## Protocol Section
### Identification Module
**NCT ID:** NCT04376879

**Brief Title:** Predicting the Need for Intubation in Hospitalised COVID-19 Patients (PRED ICU COVID19)

**Official Title:** Predicting the Need for Intubation in Hospitalised COVID-19 Patients (PRED ICU COVID19)

#### Organization Study ID Info
**ID:** 2020-A01076-33
#### Organization
**Class:** OTHER
**Full Name:** Central Hospital, Nancy, France
### Status Module
#### Completion Date
**Date:** 2021-05-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-09-10

**Type:** ACTUAL

**Last Update Submit Date:** 2021-09-02

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-05-31

**Type:** ACTUAL

#### Start Date
**Date:** 2020-05-16

**Type:** ACTUAL

**Status Verified Date:** 2021-08

#### Study First Post Date
**Date:** 2020-05-06
**Type:** ACTUAL
**Study First Submit Date:** 2020-05-04
**Study First Submit QC Date:** 2020-05-05
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Central Hospital, Nancy, France

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** One of the main challenges of the health crisis caused by the COVID-19 epidemic is the availability of beds in intensive care units (ICUs) and, more importantly, the need for invasive mechanical ventilation (IVM) because the ICUs are currently reserved for intubated patients.

The experiences of both China and Italy indicate that a certain number of COVID-19 patients will require mechanical ventilation. However, the limited number of resuscitation beds and ventilators requires strict use of these scarce resources. As a significant proportion about 5% to 10%, of patients initially admitted to hospital with COVID-19 will require ventilation, it is essential to anticipate their need for resuscitation to improve the rare resource of beds and ventilator shortages in intensive care units.

The hypothesis of the study is that, in proven or suspected hospitalised and oxygen-requiring COVID-19 patients, an early predictive clinical score, calculated over the three first days of admission may allow for an earlier identification of patients who will require intubation and transfer to an intensive care unit for orotracheal intubation

### Conditions Module

**Conditions:**

- COVID-19

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 301

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Cohort for the creation of clinical-biological score to predict the risk of intubation in COVID-19

**Intervention Names:**

- Other: Data monitoring for 48h within the first 24 hours of admission for COVID-19

**Label:** Step 1: creation of the score

#### Arm Group 2

**Description:** Cohort for the validation of clinical-biological score to predict the risk of intubation in COVID-19

**Intervention Names:**

- Other: Data monitoring for 48h within the first 24 hours of admission for COVID-19

**Label:** Step 2: validation of the score

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Step 1: creation of the score

- Step 2: validation of the score

**Description:** The admission variables and those constituting the predictive score (blood pressure, temperature, oxygenotherapy, biological analysis...) will be collected for 48 hours after enrolment (i.e within the first 24 hours of admission )

**Name:** Data monitoring for 48h within the first 24 hours of admission for COVID-19

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Primary outcome measure for the creation of the predictive score

**Measure:** the number of intubations in COVID-19 patients initially hospitalised in wards

**Time Frame:** up to 1 month

#### Secondary Outcomes

**Description:** Secondary endpoints for validation of the predictive score

**Measure:** the number of intubations in COVID-19 patients initially hospitalised in wards.

**Time Frame:** up to 1 month

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Proven or expected COVID-19 patients hospitalised in a non-intensive care unit for less than 24 hours,
* Patients requiring oxygen therapy,
* Age ≥ 18 years old.

Exclusion Criteria:

* Patients who are opposed to taking part in the study and who are opposed to the collection and use of the data that the study aims to collect.,
* Patients who can not be intubated for medical reasons,
* Pregnant women, parturient women or nursing mothers ,
* Adult person subject to a legal protection measure (guardianship, curatorship, judicial safeguard),
* Adults person who is unable to give consent and who is not subject to a legal protection measure,
* Persons deprived of their liberty by a judicial or administrative decision,
* Persons subject to psychiatric care under duress.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Proven or expected COVID-19 patients hospitalised in a non-intensive care unit for less than 24 hours

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Colombes

**Country:** France

**Facility:** Louis Mourier hospital (AP-HP)

**Zip:** 92700

**Location 2:**

**City:** Vandœuvre-lès-Nancy

**Country:** France

**Facility:** Brabois Hospital (CHRU de Nancy)

**Zip:** 54500

#### Overall Officials

**Official 1:**

**Affiliation:** CHRU de NANCY

**Name:** Antoine KIMMOUN, MD-PhD

**Role:** STUDY_CHAIR

**Official 2:**

**Affiliation:** AP-HP, Louis Mourier Hospital

**Name:** Jean Damien RICARD, MD-PhD

**Role:** STUDY_CHAIR

**Official 3:**

**Affiliation:** Institut National de Recherche en Informatique et en Automatique

**Name:** Julie JOSSE, PhD

**Role:** STUDY_CHAIR

**Official 4:**

**Affiliation:** CHRU de NANCY

**Name:** Patrick ROSSIGNOL, MD-PhD

**Role:** STUDY_CHAIR

## 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: 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: M20490

- Name: Coronavirus 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: D000086382

- Term: COVID-19

### Misc Info Module

- Version Holder: 2024-05-24
