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

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ClinicalTrials.gov Identifier: NCT04647669
Recruitment Status : Not yet recruiting
First Posted : December 1, 2020
Last Update Posted : May 13, 2021
Sponsor:
Information provided by (Responsible Party):
The University of The West Indies

Brief 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).

Condition or disease Intervention/treatment Phase
Covid19 Drug: Remdesivir Drug: Acalabrutinib Drug: Interferon beta-1a Other: Standard of Care Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: WHO Public Health Emergency "Solidarity" Clinical Trial for COVID-19 Treatments
Estimated Study Start Date : June 1, 2021
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Placebo Comparator: Local Standard of Care
Local Standard of Care
Other: Standard of Care
Treatment according to local hospital protocol

Active Comparator: Remdesivir
Remdesivir (daily infusion for 10 days)
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.

Active Comparator: Acalabrutinib
Acalabrutinib (orally twice daily for 10 days)
Drug: Acalabrutinib
100 mg capsules twice daily every 12 h for 10 days taken with or without food.

Active Comparator: Interferon
Interferon β1a(daily injection for 6 days).
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




Primary Outcome Measures :
  1. All cause Mortality [ Time Frame: Number of days from hospital admission up to 28 days post discharge ]

Secondary Outcome Measures :
  1. Duration of hospital stay [ Time Frame: Number of days from hospital admission to discharge up to 28 days post admission ]
  2. Time to first receiving ventilation [ Time Frame: Number of days from hospital admission to day of receiving ventilatory support up to 28 days post admission ]
  3. Time to admission to the intensive care unit [ Time Frame: Number of days from hospital admission to day of admission to intensive care unit up to 28 days post admission ]


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • consenting adults (age ≥18) hospitalised with definite COVID-19
  • Patients without known allergy or contra-indications to any of the of the therapies and without anticipated transfer within 72 hours to a non- study hospital.
  • Patients admitted to a collaborating hospital Exclusion Criteria
  • AVAILABLE study drugs are contra-indicated (e.g., because of patient characteristics, chronic liver or heart disease, or some concurrent medication).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04647669


Locations
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Jamaica
Univeristy of the West Indies
Kingston, Jamaica, 7
Contact: Tomlin Paul    8769272556    tomlin.paul@uwimona.edu.jm   
Principal Investigator: Marvin E Reid, MB BS PhD         
Principal Investigator: Naydenne Williams, MBBS DM         
Sponsors and Collaborators
The University of The West Indies
Investigators
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Principal Investigator: Marvin Reid University of the West Indies
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The University of The West Indies
ClinicalTrials.gov Identifier: NCT04647669    
Other Study ID Numbers: SRD/ETH/20
First Posted: December 1, 2020    Key Record Dates
Last Update Posted: May 13, 2021
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Interferons
Interferon-beta
Interferon beta-1a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic