Polyvalent Immunoglobulin in COVID-19 Related ARds

• Status: Completed
• Trial end date: 2021-02-20
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier St Anne
• Collaborators: Groupe Hospitalier Universitaire Paris psychiatrie & neurosciences; Laboratoire français de Fractionnement et de Biotechnologies
• Treatments: Antibodies; Immunoglobulins; Immunoglobulins, Intravenous

Criteria

Inclusion Criteria:

• Any patient in intensive care:

1. Receiving invasive mechanical ventilation for less than 72 hours

2. ARDS meeting the Berlin criteria

3. PCR-proven SARS-CoV-2 infection

4. Patient, family or deferred consent (emergency clause)

5. Affiliation to a social security scheme (or exemption from affiliation)

Exclusion Criteria:

• Allergy to polyvalent immunoglobulins

• Pregnant woman or minor patient

• Known IgA deficiency

• Patient with renal failure on admission defined by a 3 times baseline creatinine or creatinine >354 micromol/L or a diuresis of less than 0.3 mL/Kg for 24 hours or anuria for 12 hours

• Participation in another interventional trial