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

NCT ID: NCT04733105

Last Updated: 2021-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1022 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-20

Study Completion Date

2021-10-30

Brief Summary

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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

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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.

Conditions

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Acute Respiratory Failure

Keywords

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COVID-19 Acute respiratory failure ARDS

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicolas De PROST, MD, PhD

Role: STUDY_CHAIR

APHP

Locations

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Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR

Créteil, , France

Site Status

Countries

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France

Other Identifiers

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APHP201254

Identifier Type: -

Identifier Source: org_study_id