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World Health Organization (WHO) COVID-19 Solidarity Trial for COVID-19 Treatments

NCT04647669 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-05-13

No results posted yet for this study

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).

Conditions

  • Covid19

Interventions

DRUG

Remdesivir

200 mg intravenous loading dose on Day 1, and 100mg intravenous once-daily for subsequent doses from Day 2 up to Day 10.

DRUG

Acalabrutinib

100 mg capsules twice daily every 12 h for 10 days taken with or without food.

DRUG

Interferon beta-1a

Interferon ß-1a will be administered intravenously at the dose of 10 μg once daily for 6 days if oxygen dependent or subcutaneously at 44 ug Day 1, Day 3, and Day 6

OTHER

Standard of Care

Treatment according to local hospital protocol

Sponsors & Collaborators

  • The University of The West Indies

    lead OTHER

Principal Investigators

  • Marvin Reid · University of the West Indies

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2021-11-30
Completion
2021-12-31

Countries

  • Jamaica

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04647669 on ClinicalTrials.gov