Condition category
Infections and Infestations
Date applied
25/03/2020
Date assigned
25/03/2020
Last edited
27/07/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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.
In 2020, the virus has spread to many countries around the world and neither a vaccine against the virus or specific treatment for COVID-19 has yet been developed. As of March 2020, it is advised that people minimize travel and social contact, and regularly wash their hands to reduce the spread of the virus.
Groups who are at a higher risk from infection with the virus, and therefore of developing COVID-19, include people aged over 70 years, people who have long-term health conditions (such as asthma or diabetes), people who have a weakened immune system and people who are pregnant. People in these groups, and people who might come into contact with them, can reduce this risk by following the up-to-date advice to reduce the spread of the virus.
There are currently no available vaccines or treatments for COVID-19. Although there have been some suggestions for untested treatments that could be added to the usual care in hospitals, none is known to help. The World Health Organization (WHO) is, therefore, organizing a study in many countries in which some of these untested treatments are compared with each other, to discover whether any do help. The study treatments are remdesivir, chloroquine or hydroxychloroquine, lopinavir plus ritonavir, and interferon-beta. Some are given as daily pills, and some as daily injections.

Who can participate?
Adults (aged over 18 years) hospitalized with definite COVID-19 and not already receiving any of the study drugs. Patients invited to join the study will be those who are admitted to a collaborating hospital. It is not possible for people to volunteer themselves or their relatives to participate.

What does the study involve?
Patients diagnosed with COVID-19 and who have consented to be part of the study will be randomly allocated to receive either local standard care alone or local standard care and one of a list of study drugs. During the study, some treatments may get removed from this list, and others may be added to it. Each patient will only receive one of the treatments.
The patients will be followed up for the entire length of their hospital stay. Death from any cause will be recorded and this will be the main result used to determine whether a drug is effective. Length of hospital stay and time to first receiving ventilation (or intensive care) will also be recorded and used to determine the drug's effectiveness.

What are the possible benefits and risks of participating?
All of the drugs tested in this study have been shown to be reasonably safe. Other than remdesivir the study drugs are used routinely to treat other conditions. All participants will receive the usual care for people with COVID-19 in each location as well as the study drug.
There are known side effects to each of the study medications. It is possible that unexpected serious side effects may occur as with any clinical trial of medicines. It is also possible that treatment with one or more of the test drugs worsens COVID-19 and increases the risk of severe illness or death.
It is possible that one or more of the drugs may reduce the severity of COVID-19, reduce need for ventilation, and reduce the risk of death.

Where is the study run from?
World Health Organization Headquarters (Switzerland)

When is the study starting and how long is it expected to run for?
March 2020 to March 2021

Who is funding the study?
Multiple funders including the World Health Organization (Switzerland)

Who is the main contact?
Dr Ana Maria Henao Restrepo, henaorestrepoa@who.int
Dr Vasee Moorthy, moorthyv@who.int
Dr Marie-Pierre Preziosi, preziosim@who.int

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ana Maria Henao Restrepo

ORCID ID

http://orcid.org/0000-0001-9910-7999

Contact details

Medical Officer
HQ/RDB R&D Blue Print
(HQ/HEO/RDB)
World Health Organization HQ
Geneva
1211
Switzerland
+41 795130039
henaorestrepoa@who.int

Type

Scientific

Additional contact

Dr Vasee Moorthy

ORCID ID

http://orcid.org/0000-0002-6535-2854

Contact details

Co-Lead
R&D Blueprint for Action to Prevent Epidemics
World Health Organization HQ
Geneva
1211
Switzerland
+41 227914760
moorthyv@who.int

Type

Scientific

Additional contact

Dr Marie-Pierre Preziosi

ORCID ID

http://orcid.org/0000-0002-9025-6493

Contact details

Co-Lead
R&D Blueprint for Action to Prevent Epidemics
World Health Organization HQ
Geneva
1211
Switzerland
+41 227913744
preziosim@who.int

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

0003361

Study information

Scientific title

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

Acronym

SOLIDARITY

Study hypothesis

The addition of treatment to the local standard of care reduces all-cause mortality in COVID-19 patients compared to the local standard of care alone.

Ethics approval

Approved 04/05/2020, WHO Research Ethics Review Committee (20, Avenue Appia – Ch-1211 Geneva 27 – Switzerland; +41 227573052; ercsec@who.int), ref: ERC.0003361

Study design

Open-label randomized multicountry clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

COVID-19 (SARS-CoV-2 infection)

Intervention

Adults (aged ≥18 years) recently hospitalized, or already in the hospital, with definite COVID-19 and, in the view of the responsible doctor, no contra-indication to any of the study drugs will be randomly allocated between five groups:
1. Local standard of care alone
OR local standard of care plus one of
2. Remdesivir (daily infusion for 10 days)
3. Chloroquine or hydroxychloroquine (two oral loading doses, then orally twice daily for 10 days)
4. Lopinavir + ritonavir (orally twice daily for 14 days)
5. Lopinavir + ritonavir ((orally twice daily for 14 days) plus interferon-beta (daily injection for 6 days)

Follow-up is until death or discharge from hospital.
Randomization is performed at one central global location through an online portal.

Intervention type

Drug

Phase

Phase III

Drug names

Remdesivir, chloroquine or hydroxychloroquine, lopinavir + ritonavir (Kaletra), interferon-beta

Primary outcome measure

All-cause mortality, subdivided by the severity of disease at the time of randomization, measured using patient records throughout the study

Secondary outcome measures

Measured using patient records:
1. Duration of hospital stay (hours)
2. Time to first receiving ventilation (or intensive care) (hours)

Overall trial start date

01/03/2020

Overall trial end date

25/03/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Adults (aged ≥18 years) hospitalized with definite COVID-19
2. Not already receiving any of the study drugs
3. Without known allergy or contraindications to any of them (in the view of the physician responsible for their care)
4. Without anticipated transfer within 72 h to a non-study hospital

Patients invited to join the study will be those who are admitted to a collaborating hospital; no wider recruitment efforts are expected

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

No specific sample size is specified in this public health emergency core protocol. It is anticipated that at least several thousand patients will be recruited into the trial.

Participant exclusion criteria

Current exclusion criteria as of 21/04/2020:
1. Any of the available study drugs are contra-indicated (e.g. because of patient characteristics, chronic liver or heart disease, or some concurrent medication)
2. Declined to participate in the study

Previous exclusion criteria:
1. Any of the available study drugs are contra-indicated (e.g. because of patient characteristics, chronic liver or heart disease, or some concurrent medication)
2. Pregnant
3. Declined to participate in the study

Recruitment start date

26/03/2020

Recruitment end date

28/02/2021

Locations

Countries of recruitment

Argentina, Brazil, Canada, Germany, Honduras, India, Indonesia, Iran, Ireland, Israel, Italy, Kenya, Lebanon, Malaysia, Norway, Peru, Philippines, Qatar, Saudi Arabia, South Africa, Spain, Switzerland, Thailand

Trial participating centre

Multiple hospital sites (to be confirmed)
-
Switzerland

Sponsor information

Organisation

World Health Organization

Sponsor details

Avenue Appia 20
Geneva
1211
Switzerland
+41 22712111
henaorestrepoa@who.int

Sponsor type

Government

Website

https://www.who.int

Funders

Funder type

Research organisation

Funder name

World Health Organization

Alternative name(s)

WHO

Funding Body Type

private sector organisation

Funding Body Subtype

International organizations

Location

Switzerland

Results and Publications

Publication and dissemination plan

This international collaboration is co-ordinated through the World Health Organization, 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.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date.

Intention to publish date

31/12/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

27/07/2020: The ethics approval was added. 21/04/2020: The following changes have been made: 1. Honduras, India, Ireland, Israel, Italy, Kenya, Lebanon, Malaysia, Philippines and Saudi Arabia have been added to the locations of recruitment. 2. The participant exclusion criteria have been changed. 02/04/2020: The trial website has been removed. 30/03/2020: Internal review. 25/03/2020: Trial’s existence confirmed by the WHO.