drugset / Trial / NCT04561219
Nitazoxanide Therapy for Patients With COVID-19 Pneumonia
Phase 2
Completed
500 enrolled
Federal University of Rio de Janeiro
ATCGen · collabComplexo Hospitalar Municipal de São Caetano do Sul · collabComplexo Hospitalar do Trabalhador de Curitiba · collabFinanciadora de Estudos e Projetos · collabHospital Central da Aeronáutica, Rio de Janeiro · collabHospital Eduardo de Menezes · collabHospital Estadual de Doenças Tropicais Dr Anuar Auad · collabHospital Geral de Fortaleza · collabHospital Geral de São Mateus Dr Manoel Bifulco · collabHospital Municipal de Barueri Dr Francisco Moran · collabHospital Naval Marcilio Dias · collabHospital Regional da Asa Norte, Brazil · collabHospital Regional de Sorocaba Dr Adib Domingos Jatene · collabHospital Universitario Pedro Ernesto · collabHospital da Força Aérea do Galeão · collabHospital das Clínicas Luzia de Pinho Melo · collabHospital das Clínicas da Universidade Federal de Pernambuco · collabHospital das Forças Armadas, Brazil · collabHospital de Força Aérea de São Paulo · collabMater Dei Hospital, Brazil · collabMinistry of Science and Technology, Brazil · collabNational Research Council, Brazil · collabSanta Casa de Misericórdia de Belo Horizonte · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
Multicenter, randomized, placebo-controlled, parallel, blinded, interventional, treatment clinical trial with two arms. Population: 500 Hospitalized patients with pneumonia derived from COVID-19 (Coronavirus Disease-19), either confirmed by RT-PCR (Real Time polymerase chain reaction), or suggested by typical findings on the computed tomography scan symptomatic. Experimental group: nitazoxanide 500mg 8 / 8 hours for 5 days. Control group: placebo 8/8 hours for 5 days.
Timeline
- Start
- 2020-04-19
- Primary completion
- 2020-10-02
- Completion
- 2020-10-02
Outcome
Missed primary endpoint
paper Admission to the intensive care unit did not differ between the groups (hazard ratio [95% confidence interval], 0.68 [0.38-1.20], p = 0.179); PMID 35492335 ↗
paper Nitazoxanide, compared with placebo, did not prevent admission to the intensive care unit for patients hospitalized with COVID-19 pneumonia. PMID 35492335 ↗
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.
- Conceicao CCS, Martins CM, Medeiros Silva M, Neto HCCF, Chiumello D, Rocco PRM, Cruz FF, Silva PL. Predicting clinical outcomes at hospital admission of patients with COVID-19 pneumonia using artificial intelligence: a secondary analysis of a randomized clinical trial. Front Med (Lausanne). 2025 May 2;12:1561980. doi: 10.3389/fmed.2025.1561980. eCollection 2025.
- Silva PL, Cruz FF, Martins CM, Herrmann J, Gerard SE, Xin Y, Cereda M, Ball L, Pelosi P, Rocco PRM. A specific combination of laboratory data is associated with overweight lungs in patients with COVID-19 pneumonia at hospital admission: secondary cross-sectional analysis of a randomized clinical trial. Front Med (Lausanne). 2023 May 16;10:1137784. doi: 10.3389/fmed.2023.1137784. eCollection 2023.
- Rocco PRM, Silva PL, Cruz FF, Tierno PFGMM, Rabello E, Junior JC, Haag F, de Avila RE, da Silva JDG, Mamede MMS, Buchele KS, Barbosa LCV, Cabral AC, Junqueira AAF, Araujo-Filho JA, da Costa LATJ, Alvarenga PPM, Moura AS, Carajeleascow R, de Oliveira MC, Silva RGF, Soares CRP, Fernandes APSM, Fonseca FG, Camargos VN, Reis JS, Franchini KG, Luiz RR, Morais S, Sverdloff C, Martins CM, Felix NS, Mattos-Silva P, Nogueira CMB, Caldeira DAF, Pelosi P, Lapa-E-Silva JR. Nitazoxanide in Patients Hospitalized With COVID-19 Pneumonia: A Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial. Front Med (Lausanne). 2022 Apr 13;9:844728. doi: 10.3389/fmed.2022.844728. eCollection 2022.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nitazoxanide | Other / unclassified | 500 mg | — |