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NCT04350580: ICAR

Polyvalent Immunoglobulin in COVID-19 Related ARds

Completed Phase 3 Last updated 19 August 2021
What this trial tests

Phase 3 trial testing Human immunoglobulin in Acute Respiratory Distress Syndrome in 146 participants. Completed in 20 February 2021.

Timeline
11 April 2020
Primary endpoint
20 November 2020
20 February 2021

Quick facts

Lead sponsorCentre Hospitalier St Anne
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment146
Start date11 April 2020
Primary completion20 November 2020
Estimated completion20 February 2021
Sites42 locations across France

Drugs / interventions tested

Conditions studied

Sponsor

Centre Hospitalier St Anne

Who can join

18 and older, any sex, with Acute Respiratory Distress Syndrome or COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Pharmaco-Immunomodulatory Therapy in COVID-19.
    Rizk JG, Kalantar-Zadeh K, Mehra MR, Lavie CJ, et al · · 2020 · cited 190× · PMID 32696108 · DOI 10.1007/s40265-020-01367-z
  2. An update on drugs with therapeutic potential for SARS-CoV-2 (COVID-19) treatment.
    Drożdżal S, Rosik J, Lechowicz K, Machaj F, et al · · 2021 · cited 186× · PMID 34991982 · DOI 10.1016/j.drup.2021.100794
  3. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review.
    Piechotta V, Chai KL, Valk SJ, Doree C, et al · · 2020 · cited 148× · PMID 32648959 · DOI 10.1002/14651858.cd013600.pub2
  4. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review.
    Piechotta V, Iannizzi C, Chai KL, Valk SJ, et al · · 2021 · cited 106× · PMID 34013969 · DOI 10.1002/14651858.cd013600.pub4
  5. Acute respiratory distress syndrome in COVID-19: possible mechanisms and therapeutic management.
    Aslan A, Aslan C, Zolbanin NM, Jafari R. · · 2021 · cited 92× · PMID 34872623 · DOI 10.1186/s41479-021-00092-9
  6. Mitochondrial network dynamics in pulmonary disease: Bridging the gap between inflammation, oxidative stress, and bioenergetics.
    Pokharel MD, Garcia-Flores A, Marciano D, Franco MC, et al · · 2024 · cited 73× · PMID 38295575 · DOI 10.1016/j.redox.2024.103049
  7. SARS-CoV-2: A comprehensive review from pathogenicity of the virus to clinical consequences.
    Lotfi M, Rezaei N. · · 2020 · cited 70× · PMID 32492197 · DOI 10.1002/jmv.26123
  8. The mechanism underlying extrapulmonary complications of the coronavirus disease 2019 and its therapeutic implication.
    Ning Q, Wu D, Wang X, Xi D, et al · · 2022 · cited 64× · PMID 35197452 · DOI 10.1038/s41392-022-00907-1

Verify or expand the search:

Other trials of Human immunoglobulin

Trials testing the same drug.

Other recruiting trials for Acute Respiratory Distress Syndrome

Currently open trials in the same condition.

Other Centre Hospitalier St Anne trials

Trials by the same sponsor.

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