NCT04647669

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at below P25 for phase_3 covid19

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 1, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

May 13, 2021

Status Verified

October 1, 2020

Enrollment Period

6 months

First QC Date

October 15, 2020

Last Update Submit

May 10, 2021

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

  • All cause Mortality

    Number of days from hospital admission up to 28 days post discharge

Secondary Outcomes (3)

  • Duration of hospital stay

    Number of days from hospital admission to discharge up to 28 days post admission

  • Time to first receiving ventilation

    Number of days from hospital admission to day of receiving ventilatory support up to 28 days post admission

  • Time to admission to the intensive care unit

    Number of days from hospital admission to day of admission to intensive care unit up to 28 days post admission

Study Arms (4)

Local Standard of Care

PLACEBO COMPARATOR

Local Standard of Care

Other: Standard of Care

Remdesivir

ACTIVE COMPARATOR

Remdesivir (daily infusion for 10 days)

Drug: Remdesivir

Acalabrutinib

ACTIVE COMPARATOR

Acalabrutinib (orally twice daily for 10 days)

Drug: Acalabrutinib

Interferon

ACTIVE COMPARATOR

Interferon β1a(daily injection for 6 days).

Drug: Interferon beta-1a

Interventions

RemdesivirDRUG

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

Remdesivir
AcalabrutinibDRUG

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

Acalabrutinib
Interferon beta-1aDRUG

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

Interferon
Standard of CareOTHER

Treatment according to local hospital protocol

Local Standard of Care

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • AVAILABLE study drugs are contra-indicated (e.g., because of patient characteristics, chronic liver or heart disease, or some concurrent medication).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univeristy of the West Indies

Kingston, 7, Jamaica

Location

Related Publications (2)

  • 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.

    PMID: 36695483DERIVED

  • 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.

    PMID: 34350582DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

remdesiviracalabrutinibInterferon beta-1aStandard of Care

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Interferon-betaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Marvin Reid

    University of the West Indies

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2020

First Posted

December 1, 2020

Study Start

June 1, 2021

Primary Completion

November 30, 2021

Study Completion

December 31, 2021

Last Updated

May 13, 2021

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

JA(1)