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| ID | Type | Description | Link |
|---|---|---|---|
| RBR-88bs9x | Other Identifier | Registro Brasileiro de Ensaios ClÃnicos (REBEC) | |
| 30662420.0.1001.0008 | Other Identifier | Comitê Nacional de Ética em Pesquisa (CONEP) |
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| Name | Class |
|---|---|
| Ministry of Science and Technology, Brazil | OTHER |
| National Research Council, Brazil | OTHER |
| Financiadora de Estudos e Projetos | OTHER |
| ATCGen |
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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.
SARITA-1 is a multicenter, randomized, placebo-controlled, parallel, blinded, interventional, treatment clinical trial with two arms, which aims to study the impact of nitazoxanide for hospitalized patients with pneumonia derived from COVID-19 (Coronavirus Disease-19) Experimental group: 250 patients received nitazoxanide 500mg 8 / 8 hours for 5 days. Control group: 250 patients received placebo 8/8 hours for 5 days.
Population: Patients with clinical symptoms of COVID-19: dyspnoea and/or fever and/or cough) and: either computed tomography scan suggestive of viral pneumonia or confirmatory molecular test by RT-PCR (Real Time polymerase chain reaction),
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitazoxanide | Experimental | Patients received nitazoxanide 500mg 8/8hours, for 5 days. |
|
| Placebo | Placebo Comparator | Patients received placebo 500mg 8/8hours, for 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitazoxanide | Drug | Nitazoxanide 500mg three times a day for 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Orotracheal intubation rate | Compare the intubation rate of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, in the period of 14 days; verified by clinical evolution; quantified by percentage. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalisation days | Compare the number of days patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, stayed at the hospital, in the period of 14 days; verified by clinical evolution; quantified by absolute number. | 14 days |
| ICU days |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events - percentage | Assess the incidence and profile of adverse events reported throughout the study, by treatment group; verified by information actively collected from patients or family members; quantified by percentage. | Day 14 |
| Adverse events - absolute number |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pedro L Silva, PhD | Universidade Federal do Rio de Janeiro | Study Chair |
| Patricia RM Rocco, MD, PhD | Universidade Federal do Rio de Janeiro | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Federal do Rio de Janeiro | Rio de Janeiro | 21941902 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27095301 | 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. | |
| 25108173 | 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. |
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The investigators plan on sharing all IPD that underlie results in a publication for editorial board, with cautious of not sharing confidential data.
Available as soon as the editorial board of the journal accepting the manuscript requires.
Editorial board of the Journal accepting the manuscript.
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| D011024 | Pneumonia, Viral |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| C041747 | nitazoxanide |
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| UNKNOWN |
| Hospital Central da Aeronáutica, Rio de Janeiro | UNKNOWN |
| Hospital da Força Aérea do Galeão | UNKNOWN |
| Hospital Naval Marcilio Dias | UNKNOWN |
| Hospital Universitario Pedro Ernesto | OTHER |
| Hospital de Força Aérea de São Paulo | UNKNOWN |
| Hospital das ClÃnicas Luzia de Pinho Melo | UNKNOWN |
| Complexo Hospitalar Municipal de São Caetano do Sul | UNKNOWN |
| Hospital Municipal de Barueri Dr Francisco Moran | UNKNOWN |
| Hospital Regional de Sorocaba Dr Adib Domingos Jatene | UNKNOWN |
| Hospital Geral de São Mateus Dr Manoel Bifulco | UNKNOWN |
| Santa Casa de Misericórdia de Belo Horizonte | OTHER |
| Mater Dei Hospital, Brazil | OTHER |
| Hospital Eduardo de Menezes | UNKNOWN |
| Hospital das ClÃnicas da Universidade Federal de Pernambuco | UNKNOWN |
| Hospital das Forças Armadas, Brazil | OTHER |
| Hospital Regional da Asa Norte, Brazil | UNKNOWN |
| Complexo Hospitalar do Trabalhador de Curitiba | UNKNOWN |
| Hospital Estadual de Doenças Tropicais Dr Anuar Auad | UNKNOWN |
| Hospital Geral de Fortaleza | OTHER_GOV |
Hospitalized patients with clinical signs of COVID-19, and either chest tomography scans suggestive of COVID-19 or confirmed by RT-PCR molecular tests, will be randomly divided into 2 groups: experimental and control groups.
Experimental group: 250 hospitalized patients diagnosed with COVID-19 derived pneumonia will receive nitazoxanide 500mg 8/8 hs for 5 days. Control group: 250 hospitalized patients diagnosed with COVID-19 derived pneumonia will receive placebo 8/8 hs for 5 days.
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Patients were randomly allocated into one of the two groups: A or B. Patients received labelled medication: A or B, by the pharmacist. Patients received an identification number, so care providers, outcomes assessors and investigators did not know anything regarding the patients' groups.
| Placebo | Drug | Placebo three times a day for 5 days |
|
Compare the number of days patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, stayed at the ICU, in the period of 14 days; verified by clinical evolution; quantified by absolute number. |
| 14 days |
| Intranasal oxygen support days | Compare the number of days patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, stayed with the support of oxygen nasal cannula, in the period of 14 days; verified by clinical evolution; quantified by absolute number. | 14 days |
| Mortality rate | Compare the mortality rate of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, in the period of 14 days; verified by clinical evolution; quantified by absolute number. | 14 days |
| Days with fever | Reduction in the duration of fever of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of clinica data; quantified by the number of days that presented the symptom. | 14 days |
| Days with cough | Reduction in the duration of cough of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of clinica data; quantified by the number of days that presented the symptom. | 14 days |
| Days with dyspnea | Reduction in the duration of dyspnea of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of clinica data; quantified by the number of days that presented the symptom. | 14 days |
| Radiologic findings | Compare chest tomographic findings of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of radiologic data; quantified by the number of patients that presented the a list of alterations. | Day1 |
| Radiologic findings | Compare chest tomographic findings of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of radiologic data; quantified by the number of patients that presented the a list of alterations. | Day7 |
| Cardiologic findings | Compare echocardiographic findings of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of echocardiographic data; quantified by the number of patients that presented the a list of alterations. | Day1 |
| Cardiologic findings | Compare echocardiographic findings of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of echocardiographic data; quantified by the number of patients that presented the a list of alterations. | Day7 |
| C-reactive protein - absolute number | To evaluate the levels of C-reactive protein (CRP) of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups. | Day 1 |
| C-reactive protein serum levels | To evaluate the levels of C-reactive protein (CRP) of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups. | Day 3 |
| C-reactive protein serum levels | To evaluate the levels of C-reactive protein (CRP) of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups. | Day 7 |
| Lactate dehydrogenase (LDH) serum levels | To evaluate the levels of lactate dehydrogenase (LDH) of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups. | Day 1 |
| Lactate dehydrogenase (LDH) serum levels | To evaluate the levels of lactate dehydrogenase (LDH) of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups. | Day 3 |
| Lactate dehydrogenase (LDH) serum levels | To evaluate the levels of lactate dehydrogenase (LDH) of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups. | Day 7 |
| Troponin serum levels | To evaluate the levels of troponin of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups. | Day 1 |
| Troponin serum levels | To evaluate the levels of troponin of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups. | Day 3 |
| Troponin serum levels | To evaluate the levels of troponin of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups. | Day 7 |
| Electrolytes serum levels | To evaluate the levels of electrolytes of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups. | Day 1 |
| Electrolytes serum levels | To evaluate the levels of electrolytes of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups. | Day 3 |
| Electrolytes serum levels | To evaluate the levels of electrolytes of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups. | Day 7 |
| Glucose serum levels | To evaluate the levels of glucose of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups. | Day 1 |
| Glucose serum levels | To evaluate the levels of glucose of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups. | Day 3 |
| Glucose serum levels | To evaluate the levels of glucose of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups. | Day 7 |
| Renal function | To evaluate renal function of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups. | Day 1 |
| Renal function | To evaluate renal function of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups. | Day 3 |
| Renal function | To evaluate renal function of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups. | Day 7 |
| Coagulogram | To evaluate coagulogram of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups. | Day 1 |
| Coagulogram | To evaluate coagulogram of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups. | Day 3 |
| Coagulogram | To evaluate coagulogram of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups. | Day 7 |
| Liver function panel | To evaluate liver function panel of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups. | Day 1 |
| Liver function panel | To evaluate liver function panel of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups. | Day 3 |
| Liver function panel | To evaluate liver function panel of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups. | Day 7 |
| Ferritin | To evaluate ferritin of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups. | Day 1 |
| Ferritin | To evaluate ferritin of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups. | Day 3 |
| Ferritin | To evaluate ferritin of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups. | Day 7 |
| D-dimer | To evaluate D-dimer of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups. | Day 1 |
| D-dimer | To evaluate D-dimer of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups. | Day 3 |
| D-dimer | To evaluate D-dimer of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups. | Day 7 |
| Blood cell count | To evaluate blood cell count of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, for 7 days; verified by laboratory tests and expressed by the absolute number between the two groups. | 7 days |
| Inflammatory mediators | To evaluate D-dimer of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups. | Day 1 |
| Inflammatory mediators | To evaluate D-dimer of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups. | Day 3 |
| Inflammatory mediators | To evaluate D-dimer of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups. | Day 7 |
Assess the incidence and profile of adverse events reported throughout the study, by treatment group; verified by information actively collected from patients or family members; quantified by absolute number. |
| Day 14 |
| Treatment discontinuation rate - absolute number | Assess the rate of treatment discontinuation due to adverse events; verified by information actively collected from patients or family members; quantified by absolute number. | Day 14 |
| Treatment discontinuation rate - percentage | Assess the rate of treatment discontinuation due to adverse events; verified by information actively collected from patients or family members; quantified by percentage. | Day 14 |
| 32511548 | 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. |
| 32405422 | 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. |
| 40385586 | Derived | 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. |
| 37261117 | Derived | 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. |
| 35492335 | Derived | 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. |
| D003333 |
| Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |