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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001549-38 | EudraCT Number |
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Explanation will be submitted later.
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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
| World Health Organization | OTHER |
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This study is an adaptive, randomized, open-label, controlled clinical trial, performed worldwide in collaboration with WHO and INSERM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care (SoC) | Other | 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. |
|
| Remdesivir + SoC | Experimental | Remdesivir 200 mg IV on day 1, followed by 100 mg IV daily infusion for 9 days plus optimized supportive care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of Care (SoC) | Other | Standard supportive care is expected to vary regionally and may change throughout the trial based on new and emerging data on best care guidelines for patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of clinical status on the ordinal 7-point severity-scale at day 15. | WHO 7-point ordinal scale:
| at day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to an improvement of one category from admission using the 7-point ordinal scale | up to 29 days | |
| Mortality: 28 days mortality; in-house mortality | up to 29 days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tobias Welte, MD, Prof. | Hannover Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gesundheit Nord gGmbH | Bremen | 28211 | Germany | |||
| Universitätsklinikum Gießen |
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| Remdesivir | Drug | Remdesivir 200mg IV on day 1, followed by 100 mg IV daily infusion for 9 days or until discharge from hospital, whichever occurs first |
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| Hospital stay: Duration of hospital stay due to COVID-19 |
| up to 29 days |
| Oxygen: Need of, time to first receiving and duration of oxygen | up to 29 days |
| Intensive care: Need of, time to first receiving and duration of intensive care | up to 29 days |
| Mechanical ventilation: Need of, time to first receiving and duration of mechanical ventilation | up to 29 days |
| ECMO: Need of, time to first receiving and duration for extracorporeal membrane oxygenation | up to 29 days |
| Superinfections, assessed with pathogen testing | up to 29 days |
| Kidney failure | up to 29 days |
| Myocardial failure | up to 29 days |
| Multiple organ failure | up to 29 days |
| Giessen |
| 35392 |
| Germany |
| Medizinische Hochschule Hannover (MHH) | Hanover | 30625 | Germany |
| Technische Universität München (TUM) | München | 81675 | Germany |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| C000606551 | remdesivir |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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