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

Acute Respiratory Failure Clinical Trial

— ANTICOV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04733105
• Other study ID #: APHP201254
• Status: Completed
• Start date: November 20, 2020
• Est. completion date: October 30, 2021

Study information

• Verified date: January 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1022
• Est. completion date: October 30, 2021
• Est. primary completion date: June 30, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure
• COVID-19
• Respiratory Distress Syndrome
• Respiratory Insufficiency

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR	Créteil

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

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