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OpenTrials
Completed

NCT Number: NCT04733105

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR

Créteil, 94010, France

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. day-28 mortality

    Time frame: 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 outcomes

  1. rate of positivity of type I anti-IFN antibodies

    Time frame: 3 months of ICU admission

    positivity of type I anti-IFN antibodies measured on a serum sample obtained at any time during ICU stay

  2. Factors associated with type I anti-IFN antibody positivity

    Time frame: 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

  3. hospital mortality

    Time frame: at day 90.

    Comparaison of hospital mortality of patients having positive versus negative type I anti-IFN antibodies

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: ANTICOV

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 1, 2021
Registry last updated
Nov 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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