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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT04733105

Collaborator

(none)

1,022

Enrollment

Location

11.3

Actual Duration (Months)

90.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Failure

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 Design

Study Type:

Observational

Actual Enrollment :

1022 participants

Observational Model:

Other

Time Perspective:

Other

Official Title:

Pronostic Value of Type I ANTi-Interferon Antibodies in Patients With COVID-19 Acute Respiratory Failure: a Multicenter Observational Study

Actual Study Start Date :

Nov 20, 2020

Actual Primary Completion Date :

Jun 30, 2021

Actual Study Completion Date :

Oct 30, 2021

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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