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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04733105
Acronym
ANTICOV
Enrollment
1022
Registered
2021-02-01
Start date
2020-11-20
Completion date
2021-10-30
Last updated
2021-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure

Keywords

COVID-19, Acute respiratory failure, ARDS

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.

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
day-28 mortalityat day-28 of intensive care unit (ICU) admissioncomparaison of day-28 mortality in patients having positive versus negative type I anti-IFN antibodies

Secondary

MeasureTime frameDescription
rate of positivity of type I anti-IFN antibodies3 months of ICU admissionpositivity 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 positivity24 hours of ICU admissionFactors associated with type I anti-IFN antibody positivity available upon hospital admission, identified using uni- and multiple logistic regression analyses
hospital mortalityat day 90.Comparaison of hospital mortality of patients having positive versus negative type I anti-IFN antibodies

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026