SOLIDARITY TRIAL PLUS: An international randomized trial of additional treatments for COVID-19 in hospitalized patients who are all receiving the local standard of care
| ISRCTN | ISRCTN18066414 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18066414 |
| EudraCT/CTIS number | 2020-001784-88 |
| Secondary identifying numbers | 1.0 |
- Submission date
- 20/04/2021
- Registration date
- 29/07/2021
- Last edited
- 09/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
COVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. This virus can infect the respiratory (breathing) system. Some people do not have symptoms but can carry the virus and pass it on to others. People who have developed the condition may develop a fever and/or a continuous cough among other symptoms. This can develop into pneumonia. Pneumonia is a chest infection where the small air pockets of the lungs, called alveoli, fill with liquid and make it more difficult to breathe.
The World Health Organization (WHO) helps evaluate drugs by randomizing their effects on important outcomes. The WHO Solidarity trial involves collaboration between hundreds of hospitals in dozens of countries. It began by evaluating four repurposed drugs and now guided by an independent Expert Group, is now evaluating addition to the local Standard of Care of other potential drugs.
Who can participate?
Adults (age 18 years or older), hospitalized with laboratory-confirmed COVID at one of the participating hospitals
What does the study involve?
Once electronic data collection has been completed the patient automatically enters the trial and a random allocation of their trial treatment is generated (by an algorithm that ensures eventual balance in the characteristics just recorded between each study drug and its controls) and displayed. The patients will be randomly allocated either to Standard of Care (SoC) or to one of the study drugs.
What are the possible benefits and risks of participating?
At all times the patient’s medical team remains solely responsible for decisions about that patient’s care and safety. Hence, if the team decides that deviation from the randomly allocated treatment is appropriate for a particular patient, this should be done, regardless of the random allocation. That patient would still be part of the trial, regardless of what treatment they were actually given.
Where is the study run from?
The World Health Organization (Switzerland)
When is the study starting and how long is it expected to run for?
June 2021 to November 2023
Who is funding the study?
The World Health Organization (Switzerland)
Who is the main contact?
Dr Ana Maria Henao Restrepo, henaorestrepoa@who.int
Dr Marie-Pierre Preziosi, preziosim@who.int
Contact information
Scientific
HQ/HEO/RDB
World Health Organization
Avenue Appia 20
Geneva
1211
Switzerland
 ORCID ID |
0000-0001-9910-7999 |
|---|---|
| Phone | +41 22 791 3402 |
| henaorestrepoa@who.int |
Scientific
HQ/UHL/IVB/APS
World Health Organization
Avenue Appia 20
Geneva
1211
Switzerland
| ORCID ID |
0000-0002-9025-6493 |
|---|---|
| Phone | +41 22 791 3744 |
| preziosim@who.int |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments |
| Scientific title | An international randomized trial of additional treatments for COVID-19 in hospitalized patients who are all receiving the local standard of care |
| Study acronym | SOLIDARITY Plus |
| Study objectives | The primary analysis will assess any effects of treatment allocation on all-cause in-hospital mortality in all patients. The main secondary analyses will assess in-hospital mortality subdivided by initial respiratory support. Further secondary analyses will assess the initiation of ventilation in lower-risk patients, and, separately, the duration of hospital stay in lower-risk patients and in higher-risk patients. |
| Ethics approval(s) |
Approved 23/06/2021, COVID-19 Research Ethics Review Committee (WHO COVID-19 ERC) (20 Avenue Appia, Geneva, 1211, Switzerland; +41 227912174; ersec@who.int), ref: CERC.0114 |
| Health condition(s) or problem(s) studied | Additional treatments for COVID-19 in hospitalized patients who are all receiving the local standard of care |
| Intervention | Once electronic data collection has been completed the patient automatically enters the trial and a random allocation of their trial treatment is generated (by an algorithm that ensures eventual balance in the characteristics just recorded between each study drug and its controls) and displayed. The patients will be randomly allocated either to Standard of Care (SoC) alone or to one of the study drugs + SoC. 1. Artesunate: 2.4 mg/kg/dose at 0 hours, 12 hours, and 24 hours and thereafter every 24 hours; IV injection; duration of treatment 7 days. This is the standard dose recommended for the treatment of severe malaria 2. Infliximab: 5 mg/kg/dose (once only), single IV infusion over 2 hours. This is the standard dose that is given repeatedly for the treatment of psoriasis 3. Imatinib: 400 mg/dose; orally once daily; duration of treatment 14 days. This is the standard maintenance dose which is at the lower end of that used for several years in the treatment of hematological malignancies Follow-up: All randomised participants are to be followed up until death or discharge from hospital. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Artesunate, infliximab, imatinib |
| Primary outcome measure | In-hospital mortality in all patients measured using patient records up to the end of hospital stay |
| Secondary outcome measures | Measured using patient records: 1. Initial respiratory support (yes/no) 2. Initiation of ventilation in lower-risk patients (yes/no) 3. Duration of hospital stay (days) |
| Overall study start date | 23/06/2021 |
| Completion date | 14/11/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | No specific sample size is specified in this public health emergency core protocol. Interim results will be kept under review by an independent Global Data and Safety Monitoring Committee, and this Committee will decide how often to conduct interim analyses. It is anticipated that at least several thousand patients will need to be recruited into the trial to give reliable answers. |
| Key inclusion criteria | The only patients invited will be those admitted to a collaborating hospital; no wider recruitment is expected. 1. Adults (age ≥18 years, which allows consent) 2. Recently hospitalized (or already in hospital) with laboratory-confirmed COVID 3. Not expected to be transferred within 72 hours 4. With, in the view of their doctors, no contra-indication to any potentially relevant study drug |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 02/08/2021 |
| Date of final enrolment | 31/03/2023 |
Locations
Countries of recruitment
- Albania
- Argentina
- Bangladesh
- Botswana
- Brazil
- Canada
- Colombia
- Dominican Republic
- Egypt
- Ethiopia
- Finland
- Honduras
- India
- Ireland
- Kenya
- Latvia
- Lebanon
- Lithuania
- Malaysia
- Mali
- Mozambique
- Nepal
- Nigeria
- North Macedonia
- Pakistan
- Panama
- Paraguay
- Philippines
- Portugal
- Switzerland
- Tunisia
- Zimbabwe
Study participating centre
Globally, many cities
1211
Switzerland
Sponsor information
Research organisation
Avenue Appia 20
Geneva
1211
Switzerland
| Phone | +41 22 791 3402 |
|---|---|
| salamik@who.int | |
| Website | https://www.who.int |
"ROR" |
https://ror.org/01f80g185 |
Funders
Funder type
Research organisation
Private sector organisation / International organizations
- Alternative name(s)
- منظمة الصحة العالمية, 世界卫生组织, Всемирная организация здравоохранения, Organisation mondiale de la Santé, Organización Mundial de la Salud, WHO, 世卫组织, ВОЗ, OMS
- Location
- Switzerland
Results and Publications
| Intention to publish date | 31/03/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | This international collaboration is co-ordinated through the World Health Organisation, which is also a sponsor of the trial. Any wholly reliable interim findings will be disseminated rapidly by the WHO. There will be group authorship recognizing the contribution of all national and local investigators and guided by the International Committee of Medical Journal Editors (ICMJE) recommendations. Although the writing committee will consist of the executive group and the WHO trial secretariat, authorship will include all steering committee members and local collaborators whose hospital, in the view of the national PI, contributed substantially towards the trial. |
| IPD sharing plan | After the trial has ended and its results have been reported, anonymized data sharing will occur as per the Policy Statement on Data Sharing by the World Health Organization (https://www.who.int/ihr/procedures/SPG_data_sharing.pdf?ua=1&ua=1) |
Editorial Notes
09/10/2024: The intention to publish date was changed from 30/09/2024 to 31/03/2025.
17/06/2024: The intention to publish date was changed from 30/06/2024 to 30/09/2024.
14/11/2023: The following changes were made to the trial record:
1. The overall end date was changed from 01/09/2023 to 14/11/2023.
2. The intention to publish date was changed from 15/03/2024 to 30/06/2024.
3. The plain English summary was updated to reflect these changes.
07/06/2023: The overall end date was changed from 30/06/2023 to 01/09/2023 and the plain English summary has been updated accordingly.
15/05/2023: The following changes were made to the trial record:
1. The overall end date was changed from 14/05/2023 to 30/06/2023.
2. The recruitment end date was changed from 14/05/2023 to 31/03/2023.
3. The countries of recruitment "Bahamas, Belize, Bolivia, Ecuador, Georgia, Guyana, Indonesia, Iran, Italy, Jamaica, Kuwait, Mexico, Niger, Norway, Oman, Peru, Romania, Saudi Arabia, Sierra Leone, Spain, Trinidad and Tobago" were removed, and "Nepal, Tunisia" were added.
4. The intention to publish date was changed from 03/01/2024 to 15/03/2024.
05/07/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/05/2022 to 14/05/2023.
2. The intention to publish date was changed from 01/07/2022 to 03/01/2024.
11/05/2022: The overall trial end date has been changed from 14/05/2022 to 14/05/2023 and the plain English summary has been updated accordingly.
07/10/2021: Internal review.
30/06/2021: Trial's existence confirmed by WHO.
