drugset / Trial / NCT04924660
Novel Experimental COVID-19 Therapies Affecting Host Response
Phase 2/3
Completed
1060 enrolled
Sean Collins
National Heart, Lung, and Blood Institute (NHLBI) · collabNational Institutes of Health (NIH) · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The overarching goal of the Master Protocol is to find effective strategies for inpatient management of patients with COVID-19. Therapeutic goals for patients hospitalized for COVID-19 include hastening recovery and preventing progression to critical illness, multiorgan failure, or death. Our objective is to determine whether modulating the host tissue response improves clinical outcomes among patients with COVID-19. The primary analysis will include data from NCT05593770.
Timeline
- Start
- 2021-07-15
- Primary completion
- 2023-10-25
- Completion
- 2023-12-31
Outcome
Missed primary endpoint
paper fostamatinib did not increase the number of oxygen-free days compared with placebo. PMID 39625722 ↗
paper RAS modulation (TXA-127 or TRV-027) did not improve oxygen-free days vs placebo. PMID 37039791 ↗
Publications
- Collins SP, Shotwell MS, Strich JR, Gibbs KW, de Wit M, Files DC, Harkins M, Hudock K, Merck LH, Moskowitz A, Apodaca KD, Barksdale A, Safdar B, Javaheri A, Sturek JM, Schrager H, Iovine NM, Tiffany B, Douglas I, Levitt J, Ginde AA, Hager DN, Shapiro N, Duggal A, Khan A, Lanspa M, Chen P, Gentile N, Harris E, Gong M, Sellers S, Goodwin AJ, Tidswell MA, Filbin M, Desai N, Gutierrez F, Estrada V, Burgos J, Boyles T, Pano-Pardo JR, Hussen N, Rosenberg Y, Troendle J, Bernard GR, Bistran-Hall AJ, Walsh K, Casey JD, DeClercq J, Joly MM, Pulley J, Rice TW, Schildcrout JS, Wang L, Semler MW, Self WH; ACTIV-4 Host Tissue Investigators. Fostamatinib for Hospitalized Adults With COVID-19 and Hypoxemia: A Randomized Clinical Trial. JAMA Netw Open. 2024 Dec 2;7(12):e2448215. doi: 10.1001/jamanetworkopen.2024.48215.
- Self WH, Shotwell MS, Gibbs KW, de Wit M, Files DC, Harkins M, Hudock KM, Merck LH, Moskowitz A, Apodaca KD, Barksdale A, Safdar B, Javaheri A, Sturek JM, Schrager H, Iovine N, Tiffany B, Douglas IS, Levitt J, Busse LW, Ginde AA, Brown SM, Hager DN, Boyle K, Duggal A, Khan A, Lanspa M, Chen P, Puskarich M, Vonderhaar D, Venkateshaiah L, Gentile N, Rosenberg Y, Troendle J, Bistran-Hall AJ, DeClercq J, Lavieri R, Joly MM, Orr M, Pulley J, Rice TW, Schildcrout JS, Semler MW, Wang L, Bernard GR, Collins SP; ACTIV-4 Host Tissue Investigators. Renin-Angiotensin System Modulation With Synthetic Angiotensin (1-7) and Angiotensin II Type 1 Receptor-Biased Ligand in Adults With COVID-19: Two Randomized Clinical Trials. JAMA. 2023 Apr 11;329(14):1170-1182. doi: 10.1001/jama.2023.3546.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fostamatinib | Small molecule | 100 mg | Oral |
| Subject | Fostamatinib | Small molecule | 150 mg | Oral |
| Subject | TRV120027 | Peptide | 12 mg | Intravenous |
| Subject | talfirastide | Peptide | 0.5 mg/kg | Intravenous |