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An international randomised trial of additional treatments for COVID-19 in hospitalised patients who are all receiving the local standard of care

Trial Profile

An international randomised trial of additional treatments for COVID-19 in hospitalised patients who are all receiving the local standard of care

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 May 2021

At a glance

  • Drugs Acalabrutinib (Primary) ; Interferon beta-1a (Primary) ; Remdesivir (Primary)
  • Indications COVID 2019 infections
  • Focus Therapeutic Use
  • Acronyms SOLIDARITY
  • Most Recent Events

    • 25 Apr 2021 This trial has been discontinued in Czech Republic, according to European Clinical Trials Database record.
    • 25 Mar 2021 Status changed from active, no longer recruiting to completed.
    • 07 Mar 2021 This trial has been suspended in Spain, according to European Clinical Trials Database record.

Trial Overview

Purpose

The aim of this core protocol is to compare the effects on major outcomes in hospital of the local standard of care alone versus the local standard of care plus one of four alternative anti-viral agents. The primary objective of this large international randomised trial is to provide reliable estimates on any effects of these anti-viral treatments on in-hospital mortality in moderate and in severe COVID

Primary Endpoints

The primary outcome is all-cause mortality, subdivided by severity of disease at the time of randomization.

Timepoint(s) of evaluation of this end point: At discharge or death.

Other Endpoints

Duration of hospital stay

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

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

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 [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 100000

  • Sex male & female
  • Age Group ≥ 18 years; adult; elderly

Patient 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

Patient Exclusion Criteria

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

Trial Details

Identifiers

Identifier Owner
CTRI2020-04-024773 Clinical Trials Registry - India
NCT04647669 ClinicalTrials.gov: US National Institutes of Health
EudraCT2020-001366-11 European Clinical Trials Database
IRCT20200405046953N1 Iranian Registry of Clinical Trials
83971151 ISRCTN: Current Controlled Trials
0003361 -
ERC0003361 -
SRD-ETH20 -

Trial Dates

  • Initiation Dates

    Planned : 01 Feb 2021

    Actual : 27 Mar 2020

  • Primary Completion Dates

    Planned : 30 Nov 2021

  • End Dates

    Planned : 31 Dec 2021

    Actual : 25 Mar 2021

Other Details

  • Design multicentre; open; parallel; prospective; randomised
  • Phase of Trial Phase III
  • Location Albania; Argentina; Australia; Azerbaijan; Brazil; Canada; Colombia; Czech Republic; Egypt; Finland; France; Georgia; Germany; Honduras; India; Iran; Ireland; Italy; Jamaica; Kazakhstan; Kuwait; Latvia; Lebanon; Lithuania; Macedonia; Malaysia; Mali; Norway; Pakistan; Peru; Philippines; Portugal; Romania; Saudi Arabia; Slovakia; South Africa; Spain; Sweden; Switzerland; Thailand
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
AcalabrutinibPrimary Drug Oral Capsule
Interferon beta-1aPrimary Drug Intravenous Injection
RemdesivirPrimary Drug Intravenous Infusion

Product Name: Remdesivir
INN-Proposed INN: REMDESIVIR
Pharmaceutical Form: Lyophilisate for solution for infusion
IMP Routes of Administration: Intravenous use
Active Substance Current Sponsor Code: REMDESIVIR
Active Substance other descriptive name: REMDESIVIR
EV Substance code: SUB195655
Active Substance INN: REMDESIVIR
Active Substance Concentration unit: mg milligram(s)
Active Substance Concentration type: equal
Active Substance Concentration: 100
Chemical Origin Active Substance: yes

Product Name: Acalabrutinib
INN-Proposed INN: ACALABRUTINIB
Pharmaceutical Form: Capsule
IMP Routes of Administration: Oral use
Active Substance Current Sponsor Code: ACALABRUTINIB
EV Substance code: SUB182073
Active Substance INN: ACALABRUTINIB
Active Substance Concentration unit: mg milligram(s)
Active Substance Concentration type: equal
Active Substance Concentration: 100
Chemical Origin Active Substance: yes

Number Of treatment arms In the trial: 5

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
-
Multiple hospital sites (to be confirmed), World Health Organization Switzerland
Dr Ana Maria Henao Restrepo
Medical Officer HQ/RDB R&D Blue Print (HQ/HEO/RDB) World Health Organization HQ Geneva 1211 Switzerland +41 795130039 henaorestrepoa@who.int http://orcid.org/0000-0001-9910-7999
show details
Medical Officer Switzerland
SCREN-UICEC
profesor martin lagos s/n
Madrid
Postcode: 28040
Spain
Telephone: +349133030007360
Fax: +34913303515
fibucicec.hcsc@salud.madrid.org
show details
FIB-HCSC Spain

Centres

Centre Name Location Trial Centre Country
-
-
Argentina
-
-
Brazil
-
-
Canada
-
-
Germany
-
-
Honduras
-
-
India
-
-
Indonesia
-
-
Iran
-
-
Ireland
-
-
Israel
-
-
Italy
-
-
Kenya
-
-
Lebanon
-
-
Malaysia
-
-
Norway
-
-
Peru
-
-
Philippines
-
-
Qatar
-
-
Saudi-Arabia
-
-
South-Africa
-
-
Spain
-
-
Thailand
FIB-HCSC Madrid Spain
Medical Officer Geneva Switzerland
Multiple hospital sites (to be confirmed)
-
Switzerland
World Health Organization Geneva Switzerland

Trial History

Event Date Event Type Comment
21 May 2021 Other trial event Last checked against European Clinical Trials Database record. Updated 21 May 2021
19 May 2021 Other trial event Last checked against ClinicalTrials.gov: US National Institutes of Health record. Updated 19 May 2021
25 Apr 2021 Other trial event This trial has been discontinued in Czech Republic, according to European Clinical Trials Database record. Updated 27 Apr 2021
01 Apr 2021 Other trial event Last checked against ISRCTN: Current Controlled Trials record. Updated 01 Apr 2021
25 Mar 2021 Status change - completed Status changed from active, no longer recruiting to completed. Updated 01 Apr 2021
07 Mar 2021 Other trial event This trial has been suspended in Spain, according to European Clinical Trials Database record. Updated 08 Mar 2021
02 Jan 2021 Other trial event Planned initiation date changed from 1 Dec 2020 to 1 Feb 2021. Updated 06 Jan 2021
04 Dec 2020 Other trial event New source identified and integrated (ClinicalTrial.gov: NCT04647669) Updated 04 Dec 2020
19 Nov 2020 Results Trial design of SOLIDARITY and DISCOVERY, presented at the 23rd Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research. Updated 20 Nov 2020
20 Oct 2020 Other trial event According to a Ligand Pharmaceuticals media release, Matthew Davis's views on this study were discussed at the company's Investor Day Event. Dr. Davis's views are that the data are preliminary, not peer-reviewed and incomplete, that the open-label, non-placebo-controlled trial design is a limitation of the study, and that finalized peer-reviewed results are needed to confirm these findings. Updated 22 Oct 2020
19 Oct 2020 Status change - active, no longer recruiting Status changed from recruiting to active, no longer recruiting. Updated 04 Mar 2021
18 Aug 2020 Other trial event According to a Faron Pharmaceuticals media release, in July, WHO took the decision to remove the hydroxychloroquine and lopinavir/ritonavir treatment arms from the trial due to insufficient evidence of benefit. This leaves IFN beta-1a and remdesivir as the only two drugs remaining in the trial, subject to WHO announcing further new compounds for inclusion. Updated 26 Aug 2020
04 Aug 2020 Other trial event New source identified and integrated Iranian Registry of Clinical Trials (IRCT20200405046953N1) Updated 04 Aug 2020
30 Jul 2020 Other trial event New source identified and integrated(Clinical Trials Registry - India;CTRI2020-04-024773). Updated 30 Jul 2020
27 Jul 2020 Other trial event Recruitment completion is expected on 28 Feb 2021, according to ISRCTN: Current Controlled Trials. Updated 29 Jul 2020
27 Apr 2020 Other trial event According to a Faron Pharmaceuticals media release, the Company will donate supplies of its investigational intravenous (IV) interferon (IFN) beta-1a for 2,000 patients in the World Health Organization's (WHO) Solidarity trial. Updated 31 Aug 2020
14 Apr 2020 Other trial event New source identified and integrated (European Clinical Trials Database;EudraCT2020-001366-11) Updated 14 Apr 2020
31 Mar 2020 New trial record New trial record Updated 31 Mar 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2021;.

    Available from: URL: http://clinicaltrials.gov
  2. Faron Pharmaceuticals. Faron Pharmaceuticals Oy- Traumakine update. Media-Rel 2020;.

    Media Release
  3. ISRCTN: Current Controlled Trials. Trial-Reg 2021;.

    Available from: URL: http://www.controlled-trials.com
  4. Iranian Registry of Clinical Trials. Trial-Reg 2016;.

    Available from: URL: http://www.irct.ir/
  5. European Clinical Trials Database. Trial-Reg 2021;.

    Available from: URL: https://www.clinicaltrialsregister.eu
  6. Ligand Pharmaceuticals. Ligand Provides Highlights from Todays Investor Day Event. Media-Rel 2020;.

    Media Release
  7. Clinical Trials Registry - India. Trial-Reg 2021;.

    Available from: URL: http://ctri.nic.in/
  8. Faron Pharmaceuticals. Traumakine to be a part of WHO's Solidarity trial investigating potential COVID-19 treatments. Media-Rel 2020;.

    Media Release
  9. Liang S, Qiu T, Wang Y, Han R, Dabbous O, Toumi M. COVID-19- Why Solidarity and Discovery Trials MAY Fail to Bring Informative and Timely Results? EISPOR-2020 2020; abstr. PDG75.

    Available from: URL: https://www.ispor.org/heor-resources/presentations-database/presentation/euro2020-3282/108478
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