drugset / Trial / NCT04647669
World Health Organization (WHO) COVID-19 Solidarity Trial for COVID-19 Treatments
RandomizedParallel-groupOpen-labelTreatment
Summary
In early 2020 there were no approved anti-viral treatments for COVID19 Infection. The SOLIDARITY trial is a multicentre adaptive international randomised trial sponsored by Word Health Organization to determine the efficacy of Remdesivir (daily infusion for 10 days), or Acalabrutinib (orally twice daily for 10 days), or Interferon β1a(daily injection for 6 days) compared with local standard of care in patients admitted to hospital for COVID19 infection on all-cause mortality, stratified by severity of disease at the time of randomisation. The major secondary outcomes are duration of hospital stay and time to first receiving ventilation (or intensive care).
Timeline
- Start
- 2021-06-01
- Primary completion
- 2021-11-30
- Completion
- 2021-12-31
Publications
- Grundeis F, Ansems K, Dahms K, Thieme V, Metzendorf MI, Skoetz N, Benstoem C, Mikolajewska A, Griesel M, Fichtner F, Stegemann M. Remdesivir for the treatment of COVID-19. Cochrane Database Syst Rev. 2023 Jan 25;1(1):CD014962. doi: 10.1002/14651858.CD014962.pub2.
- Ansems K, Grundeis F, Dahms K, Mikolajewska A, Thieme V, Piechotta V, Metzendorf MI, Stegemann M, Benstoem C, Fichtner F. Remdesivir for the treatment of COVID-19. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD014962. doi: 10.1002/14651858.CD014962.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Acalabrutinib | Small molecule | 100 mg | Oral |
| Comparator | Interferon beta-1a | Protein / enzyme biologic | 10 ug | Intravenous |
| Comparator | Interferon beta-1a | Protein / enzyme biologic | 44 ug | Intravenous |
| Comparator | Remdesivir | Small molecule | 100 mg | Intravenous |