NCT04324047: CORIMUNO-19

Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients

Status unknown Last updated 1 April 2020

What this trial tests

trial in Corona Virus Infection in 1,000 participants. Status unknown.

Timeline

27 March 2020

Primary endpoint
27 March 2021

31 December 2021

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	1,000
Start date	27 March 2020
Primary completion	27 March 2021
Estimated completion	31 December 2021
Sites	3 locations across France

Conditions studied

• Corona Virus Infection — all drugs for Corona Virus Infection →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 and older, any sex, with Corona Virus Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The overall objective of the study is to determine which treatments (e.g. immune modulator drugs) have the most favorable benefit-risk in adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation.

The specific aims of this Covid19 cohort are to collect observational data at regular intervals on an ongoing basis in order to embed a series of randomized controlled trials evaluating a various set of interventions for patients with COVID-19 pneumonia. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design.

Publications & conference data

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

1. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19.
   Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, et al · · 2021 · cited 126× · PMID 34473343 · DOI 10.1002/14651858.cd013825.pub2
2. Advances in the possible treatment of COVID-19: A review.
   Chibber P, Haq SA, Ahmed I, Andrabi NI, et al · · 2020 · cited 36× · PMID 32682787 · DOI 10.1016/j.ejphar.2020.173372
3. Janus kinase inhibitors for the treatment of COVID-19.
   Kramer A, Prinz C, Fichtner F, Fischer AL, et al · · 2022 · cited 34× · PMID 35695334 · DOI 10.1002/14651858.cd015209
4. Effect of interleukin-6 receptor antagonists in critically ill adult patients with COVID-19 pneumonia: two randomised controlled trials of the CORIMUNO-19 Collaborative Group.
   Hermine O, Mariette X, Porcher R, Resche-Rigon M, et al · · 2022 · cited 32× · PMID 35115337 · DOI 10.1183/13993003.02523-2021
5. Evaluation of the safety and efficacy of XAV-19 in patients with COVID-19-induced moderate pneumonia: study protocol for a randomized, double-blinded, placebo-controlled phase 2 (2a and 2b) trial.
   Gaborit B, Vanhove B, Vibet MA, Le Thuaut A, et al · · 2021 · cited 15× · PMID 33750432 · DOI 10.1186/s13063-021-05132-9
6. The mechanistic rationale of drugs, primary endpoints, geographical distribution of clinical trials against severe acute respiratory syndrome-related coronavirus-2: A systematic review.
   Venkatesulu BP, Thoguluva Chandrasekar V, Giridhar P, V P, et al · · 2021 · cited 4× · PMID 32706390 · DOI 10.1002/jmv.26338
7. More rapid blood interferon α2 decline in fatal versus surviving COVID-19 patients.
   Joly C, Desjardins D, Porcher R, Péré H, et al · · 2023 · cited 3× · PMID 38077399 · DOI 10.3389/fimmu.2023.1250214
8. COVID-19 drug research and the cohort multiple randomised controlled trial design.
   Dal-Ré R. · · 2022 · cited 1× · PMID 35896204 · DOI 10.1183/13993003.00746-2022