Overview

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

Status:
Recruiting

Trial end date:
2021-06-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 2

Details

Lead Sponsor:

Jon Lampa
Karolinska University Hospital

Collaborators:

Karolinska Institutet
Karolinska University Hospital

Treatments:

Anti-Bacterial Agents
Interleukin 1 Receptor Antagonist Protein