An International Randomized Trial of Additional Treatments for COVID-19 in Hospitalized Patients … (NCT04575064) | Clinical Trial Compass
WithdrawnPhase 2/3
An International Randomized Trial of Additional Treatments for COVID-19 in Hospitalized Patients Who Are All Receiving the Local Standard of Care - WHO-SOLIDARITY-GERMANY
Stopped: Explanation will be submitted later.
Germany0Started 2020-06-29
Plain-language summary
This study is an adaptive, randomized, open-label, controlled clinical trial, performed worldwide in collaboration with WHO and INSERM.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients 18 years and older
* Current SARS-CoV-2 infection
* Admitted to the hospital ward or the ICU due to COVID-19
* SpO2 \<= 94% on room air OR oxygen demand OR breathing support
* Written informed consent obtained
Exclusion Criteria:
* Patient's non-consent or inability to informed consent
* Pregnant or breastfeeding women.
* Subjects pretreated with one of the study drugs in the past 29 days
* Anticipated transfer within 72 hours to a non-study hospital
* Severe co-morbidity with life expectancy \< 3 months
* AST or ALT \> 5 times the upper limit of normal
* Stage 4 severe chronic kidney disease or requiring dialysis
* Contraindications and known intolerance to any of the study drugs
* Subjects participating in a potentially confounding drug or device trial
* Any reason why the patient should not participate (investigator's opinion)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Improvement of clinical status on the ordinal 7-point severity-scale at day 15.