## Protocol Section
### Identification Module
**NCT ID:** NCT04391179

**Acronym:** DICER

**Brief Title:** Dipyridamole to Prevent Coronavirus Exacerbation of Respiratory Status (DICER) in COVID-19

**Official Title:** Dipyridamole to Prevent Coronavirus Exacerbation of Respiratory Status (DICER) in COVID-19

#### Organization Study ID Info
**ID:** HUM00179783
#### Organization
**Class:** OTHER
**Full Name:** University of Michigan
### Status Module
#### Completion Date
**Date:** 2021-02-22

**Type:** ACTUAL

#### Last Update Post Date
**Date:** 2022-03-24

**Type:** ACTUAL

**Last Update Submit Date:** 2022-03-18

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-02-22

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2022-03-24

**Type:** ACTUAL

**Results First Submit Date:** 2022-03-04

**Results First Submit QC Date:** 2022-03-18

#### Start Date
**Date:** 2020-05-31

**Type:** ACTUAL

**Status Verified Date:** 2022-03

#### Study First Post Date
**Date:** 2020-05-18
**Type:** ACTUAL
**Study First Submit Date:** 2020-05-15
**Study First Submit QC Date:** 2020-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Michigan

#### Responsible Party

**Investigator Affiliation:** University of Michigan

**Investigator Full Name:** Jason Scott Knight

**Investigator Title:** Associate Professor of Internal Medicine

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The most severe manifestations of COVID-19 include respiratory failure, coagulation problems, and death. Inflammation and blood clotting are believed to play an important role in these manifestations. Research in humans has shown that dipyridamole can reduce blood clotting. This research study is being conducted to learn whether 14 days of treatment with dipyridamole will reduce excessive blood clotting in COVID-19.

This study will enroll participants with confirmed coronavirus (SARS-CoV)-2 infection that are admitted. Eligible participants will be randomized to receive dipyridamole or placebo for 14 days in the hospital. In addition, data will be collected from the medical record, and there will also be blood draws during the hospitalization.

### Conditions Module

**Conditions:**

- COVID

- Corona Virus Infection

- Covid-19

- SARS-CoV-2 Infection

**Keywords:**

- Oxygen

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 99

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 100 milligrams (mg) by mouth (PO) four times a day (QID)

**Intervention Names:**

- Drug: Dipyridamole 100 Milligram(mg)

**Label:** Dipyridamole 100 Milligram(mg)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Placebo given by mouth four times a day

**Intervention Names:**

- Drug: Placebo oral tablet

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Dipyridamole 100 Milligram(mg)

**Description:** Drug will be given for 14 days while in the hospital.

**Name:** Dipyridamole 100 Milligram(mg)

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Placebo will be given for 14 days while in the hospital.

**Name:** Placebo oral tablet

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** average percent daily change in plasma D-dimer levels compared to baseline

**Measure:** Percent Change in D-dimer

**Time Frame:** baseline, up to approximately 14 days after last study drug administration

**Description:** Compare each dipyridamole patient head to head against each placebo patient using a hierarchical composite rank score

1. death
2. days on mechanical ventilation
3. dichotomized (yes/no) decrease in daily average SpO2/FiO2 of at least 50 units relative to day 1 at anytime during the observation period
4. cumulative sum of COVID ordinal score during study hospitalization. Ordinal scores could range 1-8. Levels 1 and 2 imply no hospitalization and 8 is the worst possible score (death); by definition, the subjects in the DICER study were hospitalized during the time period in which the study observed their ordinal scores.

**Measure:** Number of Participants With Wins at Each Level of a Hierarchical Composite Rank Score

**Time Frame:** up to approximately 30 days after hospital discharge

#### Secondary Outcomes

**Description:** Organ support is defined as receipt of invasive mechanical ventilation, vasopressor therapy, ECMO support, or dialysis.

**Measure:** Days Alive and Free of Organ Support

**Time Frame:** up to approximately 28 days after last study drug administration score

**Description:** Death of any cause during duration of study participation

**Measure:** Individual Component of Composite Endpoint- Death

**Time Frame:** up to approximately 30 days after hospital discharge

**Description:** The number of days spent on invasive mechanical ventilation during study hospitalization.

**Measure:** Individual Component of Composite Endpoint- Days on Mechanical Ventilation

**Time Frame:** up to 14 days after study drug administration

**Description:** Binary outcome indicating patients whose Sp02/Fi02 dropped 50 points relative to baseline at any time during hospitalization.

**Measure:** Individual Component of Composite Endpoint- Sp02/Fi02 (as Shown by Participant Count)

**Time Frame:** up to 14 days after study drug administration

**Description:** Cumulative sum of WHO Ordinal Scale for Clinical Improvement scores during hospitalization or through 14 days after study drug administration, whichever occurs first. The WHO Ordinal Scale ranges from 1 (no limitation of activities) through 8 (death). By definition, hospitalized patients score 3 or higher on the scale. The equation can be written: Cumulative Ordinal Score = (days in hospital up to 14) x (average ordinal score during hospitalization). Higher scores represent a combination of worse outcomes and longer hospitalizations.

**Measure:** Individual Component of Composite Endpoint- Cumulative Ordinal Score

**Time Frame:** Hospitalization up to 14 days after study drug administration

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Willing and able to provide informed consent prior to performing study procedures unless they have a legally authorized representative (LAR)
* Confirmed coronavirus (SARS-CoV-2) infection
* Currently hospitalized or anticipated hospitalization requiring supplemental oxygen

Exclusion Criteria:

* In the opinion of at least two investigators, unlikely to survive for \>48 hours from screening
* Concurrent enrollment in a clinical trial with a cytokine inhibitor (targeting interleukin-6 (IL-6), Interleukin-6 Receptor (IL-6R), IL-1, or Janus kinase). Use of remdesivir is permitted.
* Currently on invasive mechanical ventilation.
* Hypotension defined as systolic blood pressure \< 90 mmHg on two sequential readings at least 4 hours apart
* Pregnant or breastfeeding
* Concurrent dual antithrombotic therapy (aspirin or P2Y12 inhibitor plus anticoagulation to treat deep venous thrombosis or pulmonary embolism (single antiplatelet or anticoagulant agent at prophylaxis or therapeutic dose is permitted)
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 5 times upper limit of normal, hemoglobin \< 8 grams per deciliter (g/dL), or platelets \<50,000 per cubic millimeter (mm3)
* History of recent major bleeding, defined in accordance with the criteria of the International Society on Thrombosis and Hemostasis (ISTH).
* Any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Ann Arbor

**Country:** United States

**Facility:** University of Michigan

**State:** Michigan

**Zip:** 48109

#### Overall Officials

**Official 1:**

**Affiliation:** University of Michigan

**Name:** Jason Knight, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Document Section

### Large Document Module

#### Large Docs

- Date: 2021-07-12

- Filename: Prot_002.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 1336010

- Type Abbrev: Prot

- Upload Date: 2022-03-10T14:42

- Date: 2022-02-03

- Filename: SAP_003.pdf

- Has ICF: False

- Has Protocol: False

- Has SAP: True

- Label: Statistical Analysis Plan

- Size: 709870

- Type Abbrev: SAP

- Upload Date: 2022-03-10T14:44

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000011024

- Term: Pneumonia, Viral

- ID: D000011014

- Term: Pneumonia

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000003333

- Term: Coronaviridae Infections

- ID: D000030341

- Term: Nidovirales Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M2561

- Name: COVID-19

- Relevance: HIGH

- As Found: COVID-19

- ID: M10283

- Name: Infections

- Relevance: HIGH

- As Found: Infection

- ID: M6368

- Name: Communicable Diseases

- Relevance: HIGH

- As Found: Infection

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M20490

- Name: Coronavirus Infections

- Relevance: HIGH

- As Found: Corona Virus Infection

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M13904

- Name: Pneumonia

- Relevance: LOW

- As Found: Unknown

- ID: M13914

- Name: Pneumonia, Viral

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6555

- Name: Coronaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M23685

- Name: Nidovirales Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007239

- Term: Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000086382

- Term: COVID-19

- ID: D000018352

- Term: Coronavirus Infections

### Intervention Browse Module - Ancestors

- ID: D000010726

- Term: Phosphodiesterase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000010975

- Term: Platelet Aggregation Inhibitors

- ID: D000014665

- Term: Vasodilator Agents

### Intervention Browse Module - Browse Branches

- Abbrev: VaDiAg

- Name: Vasodilator Agents

- Abbrev: PlAggInh

- Name: Platelet Aggregation Inhibitors

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M7358

- Name: Dipyridamole

- Relevance: HIGH

- As Found: Positive control

- ID: M13629

- Name: Phosphodiesterase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M13865

- Name: Platelet Aggregation Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M17412

- Name: Vasodilator Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000004176

- Term: Dipyridamole

### Misc Info Module

#### Submission Tracking

##### First MCP Info

###### Post Date

- Date: 2022-03-11

- Type: ACTUAL

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Dipyridamole 100 Milligram(mg)

**Deaths Num At Risk:** 49

**Description:** 100 milligrams (mg) by mouth (PO) four times a day (QID)

Dipyridamole 100 Milligram(mg): Drug will be given for 14 days while in the hospital.

**ID:** EG000

**Other Num Affected:** 43

**Other Num at Risk:** 49

**Serious Number Affected:** 14

**Serious Number At Risk:** 49

**Title:** Dipyridamole 100 Milligram(mg)

**Group ID:** EG001

**Title:** Placebo

**Deaths Num Affected:** 3

**Deaths Num At Risk:** 50

**Description:** Placebo given by mouth four times a day

Placebo oral tablet: Placebo will be given for 14 days while in the hospital.

**ID:** EG001

**Other Num Affected:** 15

**Other Num at Risk:** 50

**Serious Number Affected:** 30

**Serious Number At Risk:** 50

**Title:** Placebo

**Frequency Threshold:** 0

#### Other Events

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Back pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Delirium

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Abdominal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Anxiety

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Epistaxis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Paresthesia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Bradycardia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Heart failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Ventricular arrhythmia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Electrocardiogram QT corrected interval prolonged

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Palpitations

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Edema limbs

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Acute kidney injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Kidney infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Atypical urothelial cells in urine

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Incontinence

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Diarrhea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Emesis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Aspartate aminotransferase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Vaginal hemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Hypotension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Thrombocytopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Rash maculo-papular

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Neck pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Ankle pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Body pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Fall

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Non-cardiac chest pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Diaphoresis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Tremor

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (5.0)

#### Serious Events

**Term:** Atrial Fibrillation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** CTCAE (5.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 49

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 50

**Term:** Delirium

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** CTCAE (5.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 49

**Group ID:** EG001

**Num At Risk:** 50

**Term:** Respiratory failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** CTCAE (5.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 7

**Num At Risk:** 49

**Group ID:** EG001

**Num Affected:** 14

**Num At Risk:** 50

**Term:** Hypotension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** CTCAE (5.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 49

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 50

**Term:** Heart failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** CTCAE (5.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 49

**Group ID:** EG001

**Num At Risk:** 50

**Term:** Lung infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** CTCAE (5.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 49

**Group ID:** EG001

**Num Affected:** 7

**Num At Risk:** 50

**Term:** Pulmonary edema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** CTCAE (5.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 49

**Group ID:** EG001

**Num At Risk:** 50

**Term:** Thromboembolic event

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** CTCAE (5.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 49

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 50

**Term:** Cardiac Arrest

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** CTCAE (5.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 49

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 50

**Term:** Myocardial infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** CTCAE (5.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 49

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 50

**Term:** Paroxysmal artrial tachycardia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** CTCAE (5.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 49

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 50

**Term:** Pneumothorax

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTCAE (5.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 49

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 50

**Term:** Stroke

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** CTCAE (5.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 49

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 50

**Time Frame:** The collection period for adverse events began after informed consent and ended 30 days after administration of the last dose of study drug.

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 49

**Group ID:** BG001

**Value:** 50

**Group ID:** BG002

**Value:** 99

**Units:** Participants

### Group

**ID:** BG000

**Title:** Dipyridamole 100 Milligram(mg)

**Description:** 100 milligrams (mg) by mouth (PO) four times a day (QID)

Dipyridamole 100 Milligram(mg): Drug will be given for 14 days while in the hospital.

### Group

**ID:** BG001

**Title:** Placebo

**Description:** Placebo given by mouth four times a day

Placebo oral tablet: Placebo will be given for 14 days while in the hospital.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 31

#### Measurement

**Group ID:** BG001

**Value:** 29

#### Measurement

**Group ID:** BG002

**Value:** 60

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 18

#### Measurement

**Group ID:** BG001

**Value:** 21

#### Measurement

**Group ID:** BG002

**Value:** 39

**Category Title:** >=65 years

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 49

**Group ID:** BG001

**Value:** 50

**Group ID:** BG002

**Value:** 99

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 16

#### Measurement

**Group ID:** BG001

**Value:** 17

#### Measurement

**Group ID:** BG002

**Value:** 33

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 33

#### Measurement

**Group ID:** BG001

**Value:** 33

#### Measurement

**Group ID:** BG002

**Value:** 66

**Category Title:** Male

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 49

**Group ID:** BG001

**Value:** 50

**Group ID:** BG002

**Value:** 99

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 1

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 46

#### Measurement

**Group ID:** BG001

**Value:** 48

#### Measurement

**Group ID:** BG002

**Value:** 94

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 4

**Category Title:** Unknown or Not Reported

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 49

**Group ID:** BG001

**Value:** 50

**Group ID:** BG002

**Value:** 99

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 5

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 6

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 45

#### Measurement

**Group ID:** BG001

**Value:** 42

#### Measurement

**Group ID:** BG002

**Value:** 87

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 1

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Unknown or Not Reported

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 49

**Group ID:** BG001

**Value:** 50

**Group ID:** BG002

**Value:** 99

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** .80

**Value:** 1.06

#### Measurement

**Group ID:** BG001

**Spread:** 1.46

**Value:** 1.24

#### Measurement

**Group ID:** BG002

**Spread:** 1.18

**Value:** 1.15

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 47

**Group ID:** BG001

**Value:** 49

**Group ID:** BG002

**Value:** 96

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 70

**Value:** 308

#### Measurement

**Group ID:** BG001

**Spread:** 72

**Value:** 310

#### Measurement

**Group ID:** BG002

**Spread:** 71

**Value:** 309

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 49

**Group ID:** BG001

**Value:** 50

**Group ID:** BG002

**Value:** 99

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 5
**Description:** Baseline plasma D-dimer level
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** Three patients did not have baseline D-Dimer values on the day of study drug.
**Title:** D-Dimer
**Unit of Measure:** mg/L
### Measure 6
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Oxygen Saturation (SpO2)/Fraction of Inspired Oxygen (FiO2)
**Unit of Measure:** ratio
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** jsknight@med.umich.edu
**Organization:** University of Michigan
**Phone:** 734-763-3031
**Title:** Jason Knight, MD, PhD
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** -.089
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** .023
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** .027
**Estimate Comment:** Estimation represents log-scale difference between average daily change in D-Dimer for Dipyridamole patients minus placebo average daily change. Negative estimates indicate that D-Dimer levels decline faster in Dipyridamole versus placebo patients.
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.24
**P-Value Comment:** 
**Parameter Type:** Slope
**Parameter Value:** -.033
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** 
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** 0.78
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 97.8
**CI Upper Limit:** 1.29
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** win ratio= (the probability of a win for the dipyridamole patient)/(probability of a win for the placebo patient)
**Group Description:** A win ratio analysis of the hierarchical composite outcome requiring direct comparison of outcomes between each dipyridamole patient and placebo patient. The patient with the superior outcome is adjudicated the 'winner' and receives a +1 score, while the 'loser' scores -1.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** .98
**P-Value Comment:** 
**Parameter Type:** win ratio
**Parameter Value:** 1.00
**Statistical Comment:** 
**Statistical Method:** Mantel Haenszel
**Tested Non-Inferiority:** 
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** .08
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** .09
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
### Outcome Measure 5
#### Analysis
**CI Lower Limit:** 0.02
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 3.94
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** estimated ratio of days on mechanical ventilation for dipyridamole and placebo
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.36
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Net)
**Parameter Value:** 0.29
**Statistical Comment:** 
**Statistical Method:** regression, negative binomial
**Tested Non-Inferiority:** 
### Outcome Measure 6
#### Analysis
**CI Lower Limit:** 0.43
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 2.51
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Odds of a 50 point drop in the dipyridamole group relative to the placebo group.
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** .94
**P-Value Comment:** 
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 1.04
**Statistical Comment:** 
**Statistical Method:** Regression, Logistic
**Tested Non-Inferiority:** 
### Outcome Measure 7
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** .95
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -10.2
- **Spread:** 
- **Upper Limit:** -0.07
- **Value:** -5.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -6.9
- **Spread:** 
- **Upper Limit:** 2.3
- **Value:** -2.4
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** Composite endpoint- death
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
**Title:** Composite endpoint- mechanical ventilation during hospitalization
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
**Title:** Composite endpoint- 50+ unit drop SpO2/FiO2
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 33
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 32
**Title:** Composite endpoint- remaining (ties among patients evaluated by ordinal score)
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 28
- **Spread:** 
- **Upper Limit:** 28
- **Value:** 28
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 28
- **Spread:** 
- **Upper Limit:** 28
- **Value:** 28
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.36
- **Upper Limit:** 
- **Value:** 0.33
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.74
- **Upper Limit:** 
- **Value:** 0.88
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 14
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 14
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 9.4
- **Spread:** 
- **Upper Limit:** 21.4
- **Value:** 14.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 7.8
- **Spread:** 
- **Upper Limit:** 30.0
- **Value:** 15.0
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** average percent daily change in plasma D-dimer levels compared to baseline
**Dispersion Type:** 97.8% Confidence Interval
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** baseline, up to approximately 14 days after last study drug administration
**Title:** Percent Change in D-dimer
**Type:** PRIMARY
**Unit of Measure:** percent daily change
##### Group
**Description:** 100 milligrams (mg) by mouth (PO) four times a day (QID)

Dipyridamole 100 Milligram(mg): Drug will be given for 14 days while in the hospital.
**ID:** OG000
**Title:** Dipyridamole 100 Milligram(mg)
##### Group
**Description:** Placebo given by mouth four times a day

Placebo oral tablet: Placebo will be given for 14 days while in the hospital.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 2
**Description:** Compare each dipyridamole patient head to head against each placebo patient using a hierarchical composite rank score

1. death
2. days on mechanical ventilation
3. dichotomized (yes/no) decrease in daily average SpO2/FiO2 of at least 50 units relative to day 1 at anytime during the observation period
4. cumulative sum of COVID ordinal score during study hospitalization. Ordinal scores could range 1-8. Levels 1 and 2 imply no hospitalization and 8 is the worst possible score (death); by definition, the subjects in the DICER study were hospitalized during the time period in which the study observed their ordinal scores.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** up to approximately 30 days after hospital discharge
**Title:** Number of Participants With Wins at Each Level of a Hierarchical Composite Rank Score
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** 100 milligrams (mg) by mouth (PO) four times a day (QID)

Dipyridamole 100 Milligram(mg): Drug will be given for 14 days while in the hospital.
**ID:** OG000
**Title:** Dipyridamole 100 Milligram(mg)
##### Group
**Description:** Placebo given by mouth four times a day

Placebo oral tablet: Placebo will be given for 14 days while in the hospital.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 3
**Description:** Organ support is defined as receipt of invasive mechanical ventilation, vasopressor therapy, ECMO support, or dialysis.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** 5 participants on dipyridamole and 2 participants on placebo were excluded from this analysis because of their early withdrawal from the study (prior to 28 days after last study drug administration).
**Reporting Status:** POSTED
**Time Frame:** up to approximately 28 days after last study drug administration score
**Title:** Days Alive and Free of Organ Support
**Type:** SECONDARY
**Unit of Measure:** days
##### Group
**Description:** 100 milligrams (mg) by mouth (PO) four times a day (QID)

Dipyridamole 100 Milligram(mg): Drug will be given for 14 days while in the hospital.
**ID:** OG000
**Title:** Dipyridamole 100 Milligram(mg)
##### Group
**Description:** Placebo given by mouth four times a day

Placebo oral tablet: Placebo will be given for 14 days while in the hospital.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 4
**Description:** Death of any cause during duration of study participation
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** up to approximately 30 days after hospital discharge
**Title:** Individual Component of Composite Endpoint- Death
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** 100 milligrams (mg) by mouth (PO) four times a day (QID)

Dipyridamole 100 Milligram(mg): Drug will be given for 14 days while in the hospital.
**ID:** OG000
**Title:** Dipyridamole 100 Milligram(mg)
##### Group
**Description:** Placebo given by mouth four times a day

Placebo oral tablet: Placebo will be given for 14 days while in the hospital.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 5
**Description:** The number of days spent on invasive mechanical ventilation during study hospitalization.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** up to 14 days after study drug administration
**Title:** Individual Component of Composite Endpoint- Days on Mechanical Ventilation
**Type:** SECONDARY
**Unit of Measure:** days
##### Group
**Description:** 100 milligrams (mg) by mouth (PO) four times a day (QID)

Dipyridamole 100 Milligram(mg): Drug will be given for 14 days while in the hospital.
**ID:** OG000
**Title:** Dipyridamole 100 Milligram(mg)
##### Group
**Description:** Placebo given by mouth four times a day

Placebo oral tablet: Placebo will be given for 14 days while in the hospital.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 6
**Description:** Binary outcome indicating patients whose Sp02/Fi02 dropped 50 points relative to baseline at any time during hospitalization.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** up to 14 days after study drug administration
**Title:** Individual Component of Composite Endpoint- Sp02/Fi02 (as Shown by Participant Count)
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** 100 milligrams (mg) by mouth (PO) four times a day (QID)

Dipyridamole 100 Milligram(mg): Drug will be given for 14 days while in the hospital.
**ID:** OG000
**Title:** Dipyridamole 100 Milligram(mg)
##### Group
**Description:** Placebo given by mouth four times a day

Placebo oral tablet: Placebo will be given for 14 days while in the hospital.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 7
**Description:** Cumulative sum of WHO Ordinal Scale for Clinical Improvement scores during hospitalization or through 14 days after study drug administration, whichever occurs first. The WHO Ordinal Scale ranges from 1 (no limitation of activities) through 8 (death). By definition, hospitalized patients score 3 or higher on the scale. The equation can be written: Cumulative Ordinal Score = (days in hospital up to 14) x (average ordinal score during hospitalization). Higher scores represent a combination of worse outcomes and longer hospitalizations.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** excluded patients that died or withdrew from the study
**Reporting Status:** POSTED
**Time Frame:** Hospitalization up to 14 days after study drug administration
**Title:** Individual Component of Composite Endpoint- Cumulative Ordinal Score
**Type:** SECONDARY
**Unit of Measure:** score on a scale * days
##### Group
**Description:** 100 milligrams (mg) by mouth (PO) four times a day (QID)

Dipyridamole 100 Milligram(mg): Drug will be given for 14 days while in the hospital.
**ID:** OG000
**Title:** Dipyridamole 100 Milligram(mg)
##### Group
**Description:** Placebo given by mouth four times a day

Placebo oral tablet: Placebo will be given for 14 days while in the hospital.
**ID:** OG001
**Title:** Placebo
### Participant Flow Module
#### Group
**Description:** 100 milligrams (mg) by mouth (PO) four times a day (QID)

Dipyridamole 100 Milligram(mg): Drug will be given for 14 days while in the hospital.
**ID:** FG000
**Title:** Dipyridamole 100 Milligram(mg)
#### Group
**Description:** Placebo given by mouth four times a day

Placebo oral tablet: Placebo will be given for 14 days while in the hospital.
**ID:** FG001
**Title:** Placebo
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 49
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 50
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 34
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 34
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 15
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 16
**Recruitment Details:** Between May 2020 and January 2021, 99 eligible participants received at least one dose of study drug and were included in the analysis.
**Has Results:** True