Clinical trial · Interventional
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
NCT04575064CI-TRIAL-00081454withdrawnPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Explanation will be submitted later.
Summary
Brief summary (as posted)
This study is an adaptive, randomized, open-label, controlled clinical trial, performed worldwide in collaboration with WHO and INSERM.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| COVID-19 | — | UNRESOLVED | — |
| Moderate and Severe COVID-19 | — | UNRESOLVED | — |
| SARS-CoV-2 Infection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Remdesivir | Drug | — | UNRESOLVED |
| Standard of Care (SoC) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Standard of Care (SoC)
- description
- This arm will receive standard supportive care according to guidelines for COVID-19. This is expected to vary regionally and may change throughout the trial based on new and emerging data on best care guidelines for patients.
- interventionNames
- Other: Standard of Care (SoC)
- type
- EXPERIMENTAL
- label
- Remdesivir + SoC
- description
- Remdesivir 200 mg IV on day 1, followed by 100 mg IV daily infusion for 9 days plus optimized supportive care
- interventionNames
- Other: Standard of Care (SoC)
- Drug: Remdesivir
Primary outcomes (1)
- measure
- Improvement of clinical status on the ordinal 7-point severity-scale at day 15.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.