CClinicalTrials.gg
CompletedNCT04733105ANTICOVUpdated Nov 9, 2021

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

An observational study in Acute Respiratory Failure, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-09.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
1,022
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Acute Respiratory Failure

Keywords

  • COVID-19
  • Acute respiratory failure
  • ARDS
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In context

COVID-19

7,638 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 1,022 is above the median of 260 across 3,135 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients with proven SARS-CoV-2 infection and acute respiratory failure admitted in the intensive care unit

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

Exclusion Criteria:

  • Patient with SARS-CoV-infection but no acute respiratory failure
05

Study design

Observational model
Other
Time perspective
Other
Enrollment
1,022 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. day-28 mortality

    comparaison of day-28 mortality in patients having positive versus negative type I anti-IFN antibodies

    Time frame: at day-28 of intensive care unit (ICU) admission

Secondary outcomes

  1. 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

    Time frame: 3 months of ICU admission

  2. 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

    Time frame: 24 hours of ICU admission

  3. hospital mortality

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

    Time frame: at day 90.

07

Study locations

1 site
  • Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR
    Créteil, 94010, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04733105
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Feb 1, 2021
Start date
Nov 20, 2020
Primary completion
Jun 30, 2021
Completion
Oct 30, 2021
Last update
Nov 9, 2021

Study contacts

Nicolas De PROST, MD, PhD
study chair · APHP

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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