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Polyvalent Immunoglobulin in COVID-19 Related ARds

NCT04350580 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2021-08-19

No results posted yet for this study

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.

Conditions

  • Acute Respiratory Distress Syndrome
  • COVID-19

Interventions

DRUG

Human immunoglobulin

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Groupe Hospitalier Universitaire Paris psychiatrie & neurosciences

    collaborator UNKNOWN

  • Laboratoire français de Fractionnement et de Biotechnologies

    collaborator INDUSTRY

  • Centre Hospitalier St Anne

    lead OTHER

Principal Investigators

  • Tarek Sharshar, MD, PHD · Centre Hospitalier Sainte Anne

  • Aurélien Mazeraud, MD, PHD · Centre Hospitalier Sainte Anne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-11
Primary Completion
2020-11-20
Completion
2021-02-20

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04350580 on ClinicalTrials.gov