Pronostic Value of Type I ANTi-Interferon Antibodies in Patients With COVID-19 Acute Respiratory Failure

Completed

• Conditions: Acute Respiratory Failure

• Registration Number: NCT04733105
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

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. A recent study revealed that 10% of patients admitted in the intensive care unit (ICU) for severe COVID-19 had positive type I anti-IFN antibodies. Such finding has potentially important therapeutic implications, as patients having positive anti-IFN antibodies could benefit from targeted interventions, including plasmapheresis. 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.

Study Timeline

• Study Start: 2020-11-20
• Status Verified: 2021-01
• Study First Submitted: 2021-01-24
• Study First Submitted QC: 2021-01-29
• Study First Posted: 2021-02-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-10-30
• Last Update Submitted: 2021-11-08
• Last Update Posted: 2021-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1022

Inclusion Criteria

• 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)
• Patient or next of keen was informed of study inclusion

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
day-28 mortality	at day-28 of intensive care unit (ICU) admission	comparaison of day-28 mortality in patients having positive versus negative type I anti-IFN antibodies

Secondary Outcome Measures

Name	Time	Method
rate of positivity of type I anti-IFN antibodies	3 months of ICU admission	positivity of type I anti-IFN antibodies measured on a serum sample obtained at any time during ICU stay
Factors associated with type I anti-IFN antibody positivity	24 hours of ICU admission	Factors associated with type I anti-IFN antibody positivity available upon hospital admission, identified using uni- and multiple logistic regression analyses
hospital mortality	at day 90.	Comparaison of hospital mortality of patients having positive versus negative type I anti-IFN antibodies

Trial Locations

Locations (1)

Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR; 🇫🇷 Créteil, France