## Protocol Section
### Identification Module
**NCT ID:** NCT04374279

**Acronym:** RECOVER

**Brief Title:** Trial to Promote Recovery From COVID-19 With Endocrine Therapy

**Official Title:** A Phase II Trial to Promote Recovery From COVID-19 With Endocrine Therapy

#### Organization Study ID Info
**ID:** COV2003
#### Organization
**Class:** OTHER
**Full Name:** Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
#### Secondary ID Infos
**Domain:** JHM IRB
**ID:** IRB00249425
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2022-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-03-05

**Type:** ACTUAL

**Last Update Submit Date:** 2021-03-02

**Overall Status:** WITHDRAWN

#### Primary Completion Date
**Date:** 2022-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-04

**Type:** ESTIMATED

**Status Verified Date:** 2021-03

#### Study First Post Date
**Date:** 2020-05-05
**Type:** ACTUAL
**Study First Submit Date:** 2020-05-04
**Study First Submit QC Date:** 2020-05-04
**Why Stopped:** Limited resources.
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Patients with COVID-19 requiring inpatient hospitalization will be randomized to treatment with standard of care or standard of care + bicalutamide. This will be a randomized, open-label study to determine if bicalutamide improves the rate of clinical improvement in patients with COVID-19.

### Conditions Module

**Conditions:**

- COVID-19

- SARS-CoV 2

**Keywords:**

- COVID-19

- Coronavirus

- COVID

- SARS-COV-2

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Patients will be randomized 1:1 to bicalutamide with standard of care, or standard of care alone.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Randomized participants receive bicalutamide 150mg oral for 7 days, plus standard of care

**Intervention Names:**

- Drug: Bicalutamide 150 Mg Oral Tablet

**Label:** Standard of care and bicalutamide

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Randomized participants receive standard of care only.

**Label:** Standard of care only

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Standard of care and bicalutamide

**Description:** Bicalutamide 150 mg by mouth daily for 7 days

**Name:** Bicalutamide 150 Mg Oral Tablet

**Other Names:**

- Casodex

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Percentage of participants who are discharged from the hospital or if they have had at least a 2-point improvement on the World Health Organization (WHO) Ordinal Scale for Clinical Improvement. The WHO clinical improvement scale has a score range of 0-8 where, 0= uninfected, 1= ambulatory with no limitation of activities; 2= ambulatory with limitations to activities; 3= hospitalized, mild disease, with no oxygen therapy; 4= hospitalized, mild disease, with oxygen by mask or nasal prongs; 5= hospitalized, severe disease, with non-invasive ventilation or high-flow oxygen; 6= hospitalized, severe disease, with intubation and mechanical ventilation; 7= hospitalized, severe disease, with ventilation and additional organ support (pressors, dialysis, ECMO); 8= death

**Measure:** Percentage of participants who have clinical improvement at day 7 after randomization

**Time Frame:** up to 7 days

#### Secondary Outcomes

**Description:** Number of participants deceased for any cause

**Measure:** All-cause mortality

**Time Frame:** 28 days

**Description:** Number of calendar days in the hospital

**Measure:** Duration of hospitalization

**Time Frame:** up to 60 days

**Measure:** Percentage of patients needing upgrade to the intermediate care unit (IMC)

**Time Frame:** up to 60 days

**Description:** Number of calendar days in IMC

**Measure:** Duration of IMC stay

**Time Frame:** up to 60 days

**Measure:** Percentage of patients needing upgrade to the intensive care unit (ICU)

**Time Frame:** up to 60 days

**Description:** Number of calendar days in ICU

**Measure:** Duration of ICU stay

**Time Frame:** up to 60 days

**Measure:** Number of participants requiring mechanical ventilation

**Time Frame:** up to 60 days

**Description:** Number of calendar days requiring mechanical ventilation

**Measure:** Duration of mechanical ventilation

**Time Frame:** up to 60 days

**Description:** Number of participants who are COVID-19 positive, experiencing adverse events as defined by the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

**Measure:** Number of participants experiencing adverse events

**Time Frame:** up to 60 days

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* ≥18 years of age
* COVID-19 infection, confirmed by polymerase chain reaction (PCR) test \<=3 days from enrollment
* Require inpatient hospitalization due to COVID-19 with minimal respiratory symptoms
* Able to provide informed consent

Exclusion Criteria:

* Unable to take oral medication
* Pregnant or breastfeeding
* On non-invasive positive pressure ventilation or mechanical ventilation at time of study entry
* Requiring ≥6L oxygen or respiratory rate ≥30
* Taking bicalutamide, any systemic hormonal therapy, or prophylactic treatment for COVID-19 within one month of study entry
* Known hypersensitivity to bicalutamide or its components.
* A past medical history of cirrhosis or AST/ALT/Alk phos/bilirubin \> 3x the upper limit of normal
* Patients with a clinical history of myocardial infarction or congestive heart failure within 6 months, or with prior echocardiogram showing ejection fraction \< 40%
* Patients currently on coumadin anticoagulants due to the potential for drug-drug interactions.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Baltimore

**Country:** United States

**Facility:** Johns Hopkins Hospital

**State:** Maryland

**Zip:** 21231

#### Overall Officials

**Official 1:**

**Affiliation:** Johns Hopkins University

**Name:** Catherine H Marshall, MD/MPH

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011024

- Term: Pneumonia, Viral

- ID: D000011014

- Term: Pneumonia

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000007239

- Term: Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000018352

- Term: Coronavirus Infections

- 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: M20490

- Name: Coronavirus Infections

- 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: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- 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: D000086382

- Term: COVID-19

### Intervention Browse Module - Ancestors

- ID: D000000726

- Term: Androgen Antagonists

- ID: D000006727

- Term: Hormone Antagonists

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000970

- Term: Antineoplastic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M231527

- Name: Bicalutamide

- Relevance: HIGH

- As Found: Coronavirus

- ID: M4059

- Name: Androgens

- Relevance: LOW

- As Found: Unknown

- ID: M4057

- Name: Androgen Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000053541

- Term: Bicalutamide

### Misc Info Module

- Version Holder: 2024-05-24
