drugset / Trial / NCT04483960
Australasian COVID-19 Trial (ASCOT) ADAptive Platform Trial
Phase 3
Unknown
2200 enrolled
University of Melbourne
Aotearoa Clinical Trials · collabAustralasian Society for Infectious Diseases · collabAustralian and New Zealand Intensive Care Research Centre · collabHunter Medical Research Institute · collabThe Peter Doherty Institute for Infection and Immunity · collab
RandomizedFactorialOpen-labelTreatment
Summary
An International Multi-Centre Randomised Adaptive Platform Clinical Trial to Assess the Clinical, Virological and Immunological Outcomes in Patients with SARS-CoV-2 Infection (COVID-19).
Timeline
- Start
- 2020-07-28
- Primary completion
- 2025-07-25
- Completion
- 2025-12-31
Outcome
Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)
paper Prespecified stopping criteria were not met, precluding definitive conclusions. PMID 38320527 ↗
paper No treatment strategy met prespecified stopping criteria before trial closure, precluding definitive conclusions. PMID 38320033 ↗
Publications
- Morpeth SC, Venkatesh B, Totterdell JA, McPhee GM, Mahar RK, Jones M, Bandara M, Barina LA, Basnet BK, Bowen AC, Burke AJ, Cochrane B, Denholm JT, Dhungana A, Dore GJ, Dotel R, Duffy E, Dummer J, Foo H, Gilbey TL, Hammond NE, Hudson BJ, Jha V, Jevaji PR, John O, Joshi R, Kang G, Kaur B, Kim S, Das SK, Lau JSY, Littleford R, Marsh JA, Marschner IC, Matthews G, Maze MJ, McArthur CJ, McFadyen JD, McMahon JH, McQuilten ZK, Molton J, Mora JM, Mudaliar V, Nguyen V, O'Sullivan MVN, Pant S, Park JE, Paterson DL, Price DJ, Raymond N, Rees MA, Robinson JO, Rogers BA, Ryu WS, Sasadeusz J, Shum O, Snelling TL, Sommerville C, Trask N, Lewin SR, Hills TE, Davis JS, Roberts JA, Tong SYC. A Randomized Trial of Nafamostat for Covid-19. NEJM Evid. 2023 Nov;2(11):EVIDoa2300132. doi: 10.1056/EVIDoa2300132. Epub 2023 Oct 18.
- McQuilten ZK, Venkatesh B, Jha V, Roberts J, Morpeth SC, Totterdell JA, McPhee GM, Abraham J, Bam N, Bandara M, Bangi AK, Barina LA, Basnet BK, Bhally H, Bhusal KR, Bogati U, Bowen AC, Burke AJ, Christopher DJ, Chunilal SD, Cochrane B, Curnow JL, Das SK, Dhungana A, Di Tanna GL, Dotel R, DSouza H, Dummer J, Dutta S, Foo H, Gilbey TL, Giles ML, Goli K, Gordon A, Gyanwali P, Haksar D, Hudson BJ, Jani MK, Jevaji PR, Jhawar S, Jindal A, John MJ, John M, John FB, John O, Jones M, Joshi RD, Kamath P, Kang G, Karki AR, Karmalkar AM, Kaur B, Koganti KC, Koshy JM, Krishnamurthy MS, Lau JS, Lewin SR, Lim LL, Marschner IC, Marsh JA, Maze MJ, McGree JM, McMahon JH, Medcalf RL, Merriman EG, Misal AP, Mora JM, Mudaliar VK, Nguyen V, O'Sullivan MV, Pant S, Pant P, Paterson DL, Price DJ, Rees MA, Robinson JO, Rogers BA, Samuel S, Sasadeusz J, Sharma D, Sharma PK, Shrestha R, Shrestha SK, Shrestha P, Shukla U, Shum O, Sommerville C, Spelman T, Sullivan RP, Thatavarthi U, Tran HA, Trask N, Whitehead CL, Mahar RK, Hammond NE, McFadyen JD, Snelling TL, Davis JS, Denholm JT, Tong SYC. Anticoagulation Strategies in Non-Critically Ill Patients with Covid-19. NEJM Evid. 2023 Feb;2(2):EVIDoa2200293. doi: 10.1056/EVIDoa2200293. Epub 2022 Dec 10.
- Denholm JT, Venkatesh B, Davis J, Bowen AC, Hammond NE, Jha V, McPhee G, McQuilten Z, O'Sullivan MVN, Paterson D, Price D, Rees M, Roberts J, Jones M, Totterdell J, Snelling T, Trask N, Morpeth S, Tong SY; ASCOT ADAPT investigators. ASCOT ADAPT study of COVID-19 therapeutics in hospitalised patients: an international multicentre adaptive platform trial. Trials. 2022 Dec 14;23(1):1014. doi: 10.1186/s13063-022-06929-y.
- Bassi A, Arfin S, Joshi R, Bathla N, Hammond NE, Rajbhandari D, Tirupakuzhi Vijayaraghavan BK, Venkatesh B, Jha V. Challenges in operationalising clinical trials in India during the COVID-19 pandemic. Lancet Glob Health. 2022 Mar;10(3):e317-e319. doi: 10.1016/S2214-109X(21)00546-5. Epub 2021 Dec 22. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dalteparin sodium | Other / unclassified | 100 iu/kg | — |
| Subject | Dalteparin sodium | Other / unclassified | 200 iu/kg | — |
| Subject | Enoxaparin sodium | Other / unclassified | 1 mg/kg | — |
| Subject | Enoxaparin sodium | Other / unclassified | 1.5 mg/kg | — |
| Subject | Hyperimmune globulin | Protein / enzyme biologic | 30 ml | — |
| Subject | Nafamostat | Small molecule | 0.2 mg/kg | Intravenous |
| Subject | Nirmatrelvir | Small molecule | 150 mg | Oral |
| Subject | Nirmatrelvir | Small molecule | 300 mg | Oral |
| Subject | Remdesivir | Small molecule | 100 mg | Intravenous |
| Subject | Ritonavir | Other / unclassified | 100 mg | Oral |
| Subject | Tinzaparin | Other / unclassified | 175 iu/kg | — |