drugset / Trial / NCT04410328
Aggrenox To Treat Acute Covid-19
Phase 3
Completed
98 enrolled
Rutgers, The State University of New Jersey
Boehringer Ingelheim · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to explore the efficacy of Aggrenox in patients with SARS-CoV-2 infection with symptoms consistent with COVID-19. An anticipated total of 132 participants will be randomly divided almost equally into 2 groups: one group will receive Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally along with the standard of care and the other group with receive the standard of care only but no Dipyridamole ER 200mg/ Aspirin 25mg. Participants will be screened, enrolled, receive treatment, and followed for 28 days. The clinical and laboratory outcomes of all the participants enrolled in the study will be evaluated at the end of the study to explore if there is any difference in the outcomes between 2 groups.
Timeline
- Start
- 2020-10-21
- Primary completion
- 2021-10-15
- Completion
- 2021-10-15
Publications
- Results Macatangay BJC, Jackson EK, Abebe KZ, Comer D, Cyktor J, Klamar-Blain C, Borowski L, Gillespie DG, Mellors JW, Rinaldo CR, Riddler SA. A Randomized, Placebo-Controlled, Pilot Clinical Trial of Dipyridamole to Decrease Human Immunodeficiency Virus-Associated Chronic Inflammation. J Infect Dis. 2020 Apr 27;221(10):1598-1606. doi: 10.1093/infdis/jiz344.
- Results Li Z LX, Huang Yi-Y et al. FEP-based screening prompts drug repositioning against COVID-19. 2020.
- Results Liu X LZ, Liu S et al. . Therapeutic effects of dipyridamole on COVID-19 patients with coagulation dysfunction. 2020.
- Results Kohler D, Streienberger A, Morote-Garcia JC, Granja TF, Schneider M, Straub A, Boison D, Rosenberger P. Inhibition of Adenosine Kinase Attenuates Acute Lung Injury. Crit Care Med. 2016 Apr;44(4):e181-9. doi: 10.1097/CCM.0000000000001370.
- Results Fata-Hartley CL, Palmenberg AC. Dipyridamole reversibly inhibits mengovirus RNA replication. J Virol. 2005 Sep;79(17):11062-70. doi: 10.1128/JVI.79.17.11062-11070.2005.
- Results Cao B, Wang Y, Wen D, Liu W, Wang J, Fan G, Ruan L, Song B, Cai Y, Wei M, Li X, Xia J, Chen N, Xiang J, Yu T, Bai T, Xie X, Zhang L, Li C, Yuan Y, Chen H, Li H, Huang H, Tu S, Gong F, Liu Y, Wei Y, Dong C, Zhou F, Gu X, Xu J, Liu Z, Zhang Y, Li H, Shang L, Wang K, Li K, Zhou X, Dong X, Qu Z, Lu S, Hu X, Ruan S, Luo S, Wu J, Peng L, Cheng F, Pan L, Zou J, Jia C, Wang J, Liu X, Wang S, Wu X, Ge Q, He J, Zhan H, Qiu F, Guo L, Huang C, Jaki T, Hayden FG, Horby PW, Zhang D, Wang C. A Trial of Lopinavir-Ritonavir in Adults Hospitalized with Severe Covid-19. N Engl J Med. 2020 May 7;382(19):1787-1799. doi: 10.1056/NEJMoa2001282. Epub 2020 Mar 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aspirin | Small molecule | 25 mg | Oral |
| Subject | Dipyridamole | Other / unclassified | 200 mg | Oral |