An international randomised trial of additional treatments for COVID-19 in hospitalised patients who are all receiving the local standard of care
Latest Information Update: 22 May 2023
At a glance
- Drugs Acalabrutinib (Primary) ; Artesunate (Primary) ; Imatinib (Primary) ; Infliximab (Primary) ; Interferon beta-1a (Primary) ; Remdesivir (Primary)
- Indications COVID 2019 infections
- Focus Registrational; Therapeutic Use
- Acronyms SOLIDARITY; Solidarity PLUS
- 11 May 2023 The study has been suspended in Latvia and Portugal, according to European Clinical Trials Database record.
- 15 Sep 2022 Results published in the Gilead Sciences Media Release.
- 15 Sep 2022 According to a Gilead Sciences media release, full results from this trial were published in May 2022.
Most Recent Events
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
Comments
According to a Gilead Sciences media release, World Health Organization's (WHO) Therapeutics and COVID-19: living guideline conditionally recommends Veklury (remdesivir) for the treatment of patients with severe COVID-19 and continues to conditionally recommend Veklury in those with non-severe COVID-19 at the highest risk of hospitalization, based on final results of this trial.
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 | - |
Organisations
- Affiliations Faron Pharmaceuticals; Gilead Sciences; Ligand Pharmaceuticals
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 Registrational; Therapeutic Use
Interventions
| Drugs | Route | Formulation |
|---|---|---|
| AcalabrutinibPrimary Drug | Oral | Capsule |
| ArtesunatePrimary Drug | Intravenous | Infusion |
| ImatinibPrimary Drug | Oral | Tablet |
| InfliximabPrimary Drug | Intravenous | Infusion |
| 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
Results
Publications
-
Gilead Sciences. WHO Expands Recommendation for Veklury(R) (Remdesivir) to Patients With Severe Disease in Latest Update to COVID-19 Guideline. Media-Rel 2022;.
Media Release
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
show details
Madrid Postcode: 28040 Spain Telephone: +349133030007360 Fax: +34913303515 fibucicec.hcsc@salud.madrid.org |
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 |
|---|---|---|
| 22 May 2023 | Other trial event | Last checked against European Clinical Trials Database record. Updated 22 May 2023 |
| 11 May 2023 | Other trial event | The study has been suspended in Latvia and Portugal, according to European Clinical Trials Database record. Updated 18 May 2023 |
| 05 Oct 2022 | Other trial event | According to ClinicalTrials.gov: US National Institutes of Health status of the trial is unknown as the information has not been verified recently(Last verified: May 2021 ). Updated 05 Oct 2022 |
| 05 Oct 2022 | Other trial event | Last checked against ClinicalTrials.gov: US National Institutes of Health record. Updated 05 Oct 2022 |
| 15 Sep 2022 | Results | Results published in the Gilead Sciences Media Release. Updated 21 Oct 2022 |
| 15 Sep 2022 | Results | According to a Gilead Sciences media release, full results from this trial were published in May 2022. Updated 21 Oct 2022 |
| 15 Sep 2022 | Other trial event | According to a Gilead Sciences media release, World Health Organization's (WHO) Therapeutics and COVID-19: living guideline conditionally recommends Veklury (remdesivir) for the treatment of patients with severe COVID-19 and continues to conditionally recommend Veklury in those with non-severe COVID-19 at the highest risk of hospitalization, based on final results of this trial. Updated 19 Sep 2022 |
| 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 |
Table of Contents
References
-
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov -
Faron Pharmaceuticals. Faron Pharmaceuticals Oy- Traumakine update. Media-Rel 2020;.
Media Release -
ISRCTN: Current Controlled Trials. Trial-Reg 2023;.
Available from: URL: http://www.controlled-trials.com -
Iranian Registry of Clinical Trials. Trial-Reg 2016;.
Available from: URL: http://www.irct.ir/ -
European Clinical Trials Database. Trial-Reg 2023;.
Available from: URL: https://www.clinicaltrialsregister.eu -
Ligand Pharmaceuticals. Ligand Provides Highlights from Todays Investor Day Event. Media-Rel 2020;.
Media Release -
Gilead Sciences. WHO Expands Recommendation for Veklury(R) (Remdesivir) to Patients With Severe Disease in Latest Update to COVID-19 Guideline. Media-Rel 2022;.
Media Release -
Clinical Trials Registry - India. Trial-Reg 2021;.
Available from: URL: http://ctri.nic.in/ -
Faron Pharmaceuticals. Traumakine to be a part of WHO's Solidarity trial investigating potential COVID-19 treatments. Media-Rel 2020;.
Media Release -
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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