Polyvalent Immunoglobulin in COVID-19 Related ARds
Status:
Completed
Trial end date:
2021-02-20
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Centre Hospitalier St Anne
Collaborators:
Groupe Hospitalier Universitaire Paris psychiatrie & neurosciences Laboratoire français de Fractionnement et de Biotechnologies