CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 146 enrolled
Drug / intervention
Human immunoglobulin +1 moredrug
Likely dose
Human immunoglobulin 2gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04350580
NCT04350580Phase 3Completed

Value of Early Treatment With Polyvalent Immunoglobulin in the Management of Acute Respiratory Distress Syndrome Associated With SARS-CoV-2 Infections

Centre Hospitalier St Anne·interventional·Posted Apr 17, 2020·Updated Aug 19, 2021

In Brief

A Phase 3 clinical trial evaluating Human immunoglobulin and Placebo for Acute Respiratory Distress Syndrome and COVID-19. Completed, enrolled 146 participants across 42 sites.

Detailed Summary

As of 30/03/2020, 715600 people have been infected with COVID-19 worldwide and 35500 people died, essentially due to respiratory distress syndrome (ARDS) complicated in 25% of the with acute renal failure. No specific pharmacological treatment is available yet. The lung lesions are related to both the viral infection and to an intense inflammatory reaction. Because of it's action, as an immunomodulatory agent that can attenuate the inflammatory reaction and also strengthen the antiviral response, it is proposed to evaluate the effectiveness and safety of intravenous immunoglobulin administration (IGIV) in patients developing ARDS post-SARS-CoV2. IGIV modulates immunity, and this effect results in a decrease of pro-inflammatory activity, key factor in the ARDS related to the COVID-19. It should be noted that IGIV is part of the treatments in various diseases such as autoimmune and inflammatory diffuse interstitial lung diseases. In addition, they have been beneficial in the post-influenza ARDS but also have been in 3 cases of post-SARS-CoV2 ARDS. IGIV is a treatment option because it is well tolerated, especially concerning the kidney. These elements encourage a placebo-controlled trial testing the benefit of IGIV in ARDS post-SARS-CoV2.

Study Details

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedApr 17, 2020
Enrollment StartApr 11, 2020
Primary CompletionNov 20, 2020
Study CompletionFeb 20, 2021
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 6.2 years ago

Interventions

Human immunoglobulindrug

Human immunoglobulin 2g/kg over 4 days (0.5g/kg/d)

Placebodrug

Sodium chloride 0.9% in the same volume and over the same time as the immunoglobulin