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A clinical trial to study the effects of additional treatments for patients hospitalized and receiving treatment due to COVID -19.

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/04/024773
Enrollment
10000
Registered
2020-04-21
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

Intervention1: Imatinib: Imatinib, orally once daily for 14 days along with local standard of care Intervention2: Infliximab: Infliximab, as a single IV infusion along with local standard care treat

Sponsors

World Health Organization
Lead Sponsor
Indian Council of Medical Research
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adults (age >=18 years) recently hospitalised, or already in the hospital, with definite (diagnosed by RT-PCR) symptomatic COVID admitted for at least moderate or severe illness 2. In the view of the responsible doctor, no contra-indication to any of the study drugs. 3. Providing consent for the participation

Exclusion criteria

Exclusion criteria: 1.Adults (age >=18 years) with COVID and hospitalised for quarantine purposes or management of other conditions who do not have moderate or severe illness. 2.Laboratory confirmation of SARS Cov -2 infection not available 3.In the view of the randomising doctor, ANY of the AVAILABLE study drugs are contra-indicated Anticipated transfer to another hospital which is not a study site within 72 hours 4.Pregnant or Lactating Women

Design outcomes

Primary

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

Secondary

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

Countries

Albania, Argentina, Bahamas, Bangladesh, Belize, Bolivia, Botswana, Brazil, Canada, Colombia, Dominica, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, Georgia, Guyana, Honduras, India, Indonesia, Iran (Islamic Republic of), Ireland, Italy, Jamaica, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Mali, Mexico, Mozambique, Niger, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Portugal, Romania, Saudi Arabia, Sierra Leone, Spain, Switzerland, Trinidad and Tobago, Zimbabwe

Contacts

Public ContactDrSheela Virendra Godbole

ICMR-National AIDS Research Institute, Pune

sgodbole@nariindia.org09422087972

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026