NCT04733105

Brief Summary

Severe SARS-CoV-2 infections are frequently associated with the acute respiratory distress syndrome (ARDS), which leads to a mortality of 30-40%. An altered type I interferon (IFN) response has been demonstrated in patients with severe COVID-19, together with a high viral load. The aim of the current work is, in a large cohort of patients with severe COVID-19 admitted in the ICU, to determine the prevalence of patients with positive anti-IFN antibodies and to determine their outcome, as compared to patients having negative anti-IFN antibodies.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,022

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
Last Updated

November 9, 2021

Status Verified

January 1, 2021

Enrollment Period

7 months

First QC Date

January 24, 2021

Last Update Submit

November 8, 2021

Conditions

Acute Respiratory Failure

Keywords

COVID-19Acute respiratory failureARDS

Outcome Measures

Primary Outcomes (1)

  • day-28 mortality

    comparaison of day-28 mortality in patients having positive versus negative type I anti-IFN antibodies

    at day-28 of intensive care unit (ICU) admission

Secondary Outcomes (3)

  • rate of positivity of type I anti-IFN antibodies

    3 months of ICU admission

  • Factors associated with type I anti-IFN antibody positivity

    24 hours of ICU admission

  • hospital mortality

    at day 90.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with proven SARS-CoV-2 infection and acute respiratory failure admitted in the intensive care unit

You may qualify if:

  • Age ≥ 18 years
  • SARS-CoV-2 infection with a positive PCR
  • Patient admitted in the ICU for acute respiratory failure (SpO2≤90% and need for supplemental oxygen or any kind of ventilator support)

You may not qualify if:

  • Patient with SARS-CoV-infection but no acute respiratory failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR

Créteil, 94010, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Nicolas De PROST, MD, PhD

    APHP

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2021

First Posted

February 1, 2021

Study Start

November 20, 2020

Primary Completion

June 30, 2021

Study Completion

October 30, 2021

Last Updated

November 9, 2021

Record last verified: 2021-01

Locations

FR(1)