A Study in Patients With COVID-19 and Respiratory Distress Not Requiring Mechanical Ventilation, to Compare Standard-of-care With Anakinra and Tocilizumab Treatment The Immunomodulation-CoV Assessment (ImmCoVA) Study

Summary

The study is designed as a randomized, controlled, multi-center open-label trial to compare standard-of-care (SOC) treatment with SOC + anakinra or SOC + tocilizumab treatment in hospitalized adult subjects who are diagnosed with severe COVID 19. Arm A: Standard-of-care Treatment (SOC) Arm B: Anakinra + SOC Arm C: Tocilizumab + SOC. All subjects will be treated with standard-of-care treatment. Arms B and C will also receive broad spectrum antibiotics initiated before or latest 24 hours after initiation of treatment with study drug. The primary follow-up period of the study is 29 days.

Timeline

Start

2020-06-11

Primary completion

2021-03

Completion

2021-06

Publications

• Sunden-Cullberg J, Chen P, Habel H, Skorup P, Janols H, Rasmuson J, Niward K, Ostholm Balkhed A, Chatzidionysiou K, Asgeirsson H, Blennow O, Parke A, Svensson AK, Muvva JR, Ljunggren HG; Karolinska KI/K COVID-19 Treatment Working Group; Horne AC, Aden U, Henter JI, Sonnerborg A, Vesterbacka J, Nowak P, Lampa J. Anakinra or tocilizumab in patients admitted to hospital with severe covid-19 at high risk of deterioration (IMMCoVA): A randomized, controlled, open-label trial. PLoS One. 2023 Dec 29;18(12):e0295838. doi: 10.1371/journal.pone.0295838. eCollection 2023.

Drugs

Indications