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This study is an adaptive, randomized, open-label, controlled clinical trial utilizing an adaptive design to compare effects of repurposed drugs with local standard of care alone on major inpatient hospital outcomes. This is performed worldwide in collaboration with WHO.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LSoC | No Intervention | Local Standard of Care | |
| Rem+LSoC | Experimental | Remdesivir with Local Standard of Care |
|
| HCQ+LSoC | Experimental | Hydroxychloroquine with Local Standard of Care |
|
| Lopi/Rito+LSoC | Experimental | Lopinavir/Ritonavir with Local Standard of Care |
|
| Lopi/Rito+IFN+LSoC | Experimental | Lopinavir/Ritonavir and Interferon Beta 1a with Local Standard of Care |
|
| IFN+LSoC | Experimental | Interferon Beta 1a with Local Standard of Care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remdesivir | Drug | Two intravenous loading doses, then daily infusion for 10 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | Number of days from hospital admission up to 28 days post discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of hospital stay | Number of days from hospital admission to discharge up to 28 days post admission | |
| Time to first receiving ventilation | Number of days from hospital admission to day of receiving ventilatory support up to 28 days post admission |
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Inclusion Criteria:
Consenting adults (age ≥18) hospitalised with the following criteria will be included in the study:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baguio General Hospital | Baguio City | Benguet | Philippines | |||
| Cebu Doctor's University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36695483 | Derived | Grundeis F, Ansems K, Dahms K, Thieme V, Metzendorf MI, Skoetz N, Benstoem C, Mikolajewska A, Griesel M, Fichtner F, Stegemann M. Remdesivir for the treatment of COVID-19. Cochrane Database Syst Rev. 2023 Jan 25;1(1):CD014962. doi: 10.1002/14651858.CD014962.pub2. |
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Adaptive design
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| ACB+LSoC | Experimental | Acalabrutinib with Local Standard of Care |
|
| Hydroxychloroquine |
| Drug |
Two oral loading doses, then orally twice daily for 10 days |
|
| Lopinavir / Ritonavir | Drug | Orally twice daily for 14 days |
|
| Interferon beta-1a | Drug | Daily injection for 6 days |
|
| Acalabrutinib | Drug | Orally twice daily for 10 days |
|
| Cebu City |
| Cebu |
| Philippines |
| Perpetual Succor Hospital Cebu | Cebu City | Cebu | Philippines |
| Vicente Sotto Memorial Medical Center | Cebu City | Cebu | Philippines |
| Southern Philippines Medical Center | Davao City | Davao Region | Philippines |
| West Visayas University Medical Center | Iloilo City | Iloilo | Philippines |
| St Luke's Medical Center Global | City of Taguig | National Capital Region | Philippines |
| Makati Medical Center | Makati City | National Capital Region | Philippines |
| Chinese General Hospital | Manila | National Capital Region | Philippines |
| Manila Doctors Hospital | Manila | National Capital Region | Philippines |
| ManilaMed - Medical Center Philippines | Manila | National Capital Region | Philippines |
| San Lazaro Hospital | Manila | National Capital Region | Philippines |
| UP - Philippine General Hospital | Manila | National Capital Region | Philippines |
| Asian Hospital and Medical Center | Muntinlupa | National Capital Region | Philippines |
| Research Institute for Tropical Medicine | Muntinlupa | National Capital Region | Philippines |
| San Juan de Dios Educational Foundation Inc - Hospital | Pasay | National Capital Region | Philippines |
| The Medical City | Pasig | National Capital Region | Philippines |
| Diliman Doctors Hospital | Quezon City | National Capital Region | Philippines |
| Fe Del Mundo Medical Center | Quezon City | National Capital Region | Philippines |
| Lung Center of the Philippines | Quezon City | National Capital Region | Philippines |
| St Luke's Medical Center Quezon City | Quezon City | National Capital Region | Philippines |
| University of the East Ramon Magsaysay Memorial Medical Center | Quezon City | National Capital Region | Philippines |
| World Citi Medical Center | Quezon City | National Capital Region | Philippines |
| Cardinal Santos Medical Center | San Juan City | National Capital Region | Philippines |
| Batangas Medical Center | Batangas | Philippines |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| 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 |
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| ID | Term |
|---|---|
| C000606551 | remdesivir |
| D006886 | Hydroxychloroquine |
| D061466 | Lopinavir |
| D000068556 | Interferon beta-1a |
| C000604908 | acalabrutinib |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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