drugset / Trial / NCT04552483
Effects of Early Use of Nitazoxanide in Patients With COVID-19
Phase 2
Completed
392 enrolled
Federal University of Rio de Janeiro
ATCGen · collabComplexo Hospitalar Municipal de São Caetano do Sul · collabHospital de Transplante Doutor Euryclides de Jesus Zerbini · collabHospital e Maternidade Therezinha de Jesus · collabMinistry of Science and Technology, Brazil · collabNational Research Council, Brazil · collabSanta Casa de Misericórdia de Sorocaba · collabSecretaria Municipal de Saúde de Bauru · collabSecretaria Municipal de Saúde de Guarulhos · collabSecretaria de Estado de Saúde do Distrito Federal · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
Multicenter, randomized, placebo-controlled, parallel, blinded, interventional, treatment clinical trial with two arms. Population: 392 Patients with COVID-19 (Coronavirus Disease-19), confirmed by RT-PCR (Real Time polymerase chain reaction), symptomatic in the early phase of the disease. Experimental group: 196 patients, nitazoxanide 500mg 8 / 8 hours for 5 days. Control group: 196 patients, placebo 8/8 hours for 5 days.
Timeline
- Start
- 2020-06-08
- Primary completion
- 2020-08-20
- Completion
- 2020-09-05
Publications
- Background Rossignol JF. Nitazoxanide, a new drug candidate for the treatment of Middle East respiratory syndrome coronavirus. J Infect Public Health. 2016 May-Jun;9(3):227-30. doi: 10.1016/j.jiph.2016.04.001. Epub 2016 Apr 16.
- Background Rossignol JF. Nitazoxanide: a first-in-class broad-spectrum antiviral agent. Antiviral Res. 2014 Oct;110:94-103. doi: 10.1016/j.antiviral.2014.07.014. Epub 2014 Aug 7.
- Background Rajoli RK, Pertinez H, Arshad U, Box H, Tatham L, Curley P, Neary M, Sharp J, Liptrott NJ, Valentijn A, David C, Rannard SP, Aljayyoussi G, Pennington SH, Hill A, Boffito M, Ward SA, Khoo SH, Bray PG, O'Neill PM, Hong WD, Biagini G, Owen A. Dose prediction for repurposing nitazoxanide in SARS-CoV-2 treatment or chemoprophylaxis. medRxiv [Preprint]. 2020 May 6:2020.05.01.20087130. doi: 10.1101/2020.05.01.20087130.
- Background Pepperrell T, Pilkington V, Owen A, Wang J, Hill AM. Review of safety and minimum pricing of nitazoxanide for potential treatment of COVID-19. J Virus Erad. 2020 Apr 30;6(2):52-60. doi: 10.1016/S2055-6640(20)30017-0.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nitazoxanide | Other / unclassified | 500 mg | — |