Covid19Phase 2NCT04561219
Nitazoxanide Therapy for Patients With COVID-19 Pneumonia
A Phase 2 study testing Nitazoxanide in people with Covid19 and Corona Virus Infection, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Corona Virus Infection, Pneumonia, Viral
- What is being tested?
- Nitazoxanide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteBrazil
- Study dates
- 19 Apr 2020to 2 Oct 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients requiring supplemental oxygen [peripheral oxygen saturation (SpO2) < 93%], admitted to hospital with COVID-19 symptoms associated with chest computed tomography (CT) scan suggestive of viral pneumonia or positive nasopharyngeal swab test for SARS-CoV2 (RT-PCR)
- Age equal or superior to 18 years
- Non-pregnant women
- Willingness to receive study treatment
- Providing written and informed consent or the same consent signed by a family member
Who cannot join
- Impossibility to use oral medications
- History of severe liver disease (Child Pugh C class)
- Previous renal failure
- Severe heart failure (NYHA 3 or 4)
- COPD (GOLD 3 and 4)
- Neoplasia in the last 5 years
Show all 10Show fewer
- Known autoimmune disease
- Individuals with known hypersensitivity to study drug
- Previous treatment with the study medication during the last 30 days
- Clinical suspicion of tuberculosis and bacterial pneumonia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nitazoxanide for Moderate to Severe COVID-19 Pneumonia: a Multicenter, Randomized, Placebo-controlled, Double-Blind Clinical Trial
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.
Read the detailed description
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),
- Conditions
- Covid19, Corona Virus Infection, Pneumonia, Viral
- Being tested
- Nitazoxanide, Placebo
- Keywords
- covid19, coronavirus, clinical trial, placebo-controlled, randomized, brazil, nitazoxanide, hospitalized patients, covid-19, sars-cov-2, new coronavirus, multicenter, double-blind
- Medical subject headings
- COVID-19, Coronavirus Infections, Pneumonia, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitazoxanideDrug
Also called annita, azox, irose, tanisea
Nitazoxanide 500mg three times a day for 5 days
PlaceboDrug
Placebo three times a day for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Nitazoxanide | Experimental | Patients received nitazoxanide 500mg 8/8hours, for 5 days. Receives: Drug: Nitazoxanide |
| Placebo | Placebo comparator | Patients received placebo 500mg 8/8hours, for 5 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Secondary outcomes (45)
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.
Measured: 14 days
ICU 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start19 Apr 2020
- Primary completion2 Oct 2020
- Study completion2 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Brazil, National Research Council, Brazil, Financiadora de Estudos e Projetos, ATCGen, Hospital Central da Aeronáutica, Rio de Janeiro, Hospital da Força Aérea do Galeão, Hospital Naval Marcilio Dias, Hospital Universitario Pedro Ernesto, Hospital de Força Aérea de São Paulo, Hospital das Clínicas Luzia de Pinho Melo, Complexo Hospitalar Municipal de São Caetano do Sul, Hospital Municipal de Barueri Dr Francisco Moran, Hospital Regional de Sorocaba Dr Adib Domingos Jatene, Hospital Geral de São Mateus Dr Manoel Bifulco, Santa Casa de Misericórdia de Belo Horizonte, Mater Dei Hospital, Brazil, Hospital Eduardo de Menezes, Hospital das Clínicas da Universidade Federal de Pernambuco, Hospital das Forças Armadas, Brazil, Hospital Regional da Asa Norte, Brazil, Complexo Hospitalar do Trabalhador de Curitiba, Hospital Estadual de Doenças Tropicais Dr Anuar Auad, Hospital Geral de Fortaleza
- Responsible party
- Principal investigator, Jose Roberto Lapa e Silva, Universidade Federal do Rio de Janeiro
- Investigators
- Pedro L Silva, PhD, Study chair, Universidade Federal do Rio de JaneiroPatricia RM Rocco, MD, PhD, Principal investigator, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561219
- Sponsor's protocol ID
- SARITA-1
- Other IDs
- RBR-88bs9x, 30662420.0.1001.0008
- Status last verified
- Jul 2021
- First submitted
- 22 Sep 2020
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators plan on sharing all IPD that underlie results in a publication for editorial board, with cautious of not sharing confidential data.
Publications
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.
PubMed 27095301Rossignol 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.
PubMed 25108173Rajoli 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.
PubMed 32511548Pepperrell 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.
PubMed 32405422Conceicao 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.
PubMed 40385586Silva 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.
PubMed 37261117Rocco 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.
PubMed 35492335
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nitazoxanide for Moderate to Severe COVID-19 Pneumonia: a Multicenter, Randomized, Placebo-controlled, Double-Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT04561219
- Acronym / sponsor ID
- SARITA-1
- Conditions
- Covid19, Corona Virus Infection, Pneumonia, Viral
- Keywords
- covid19, coronavirus, clinical trial, placebo-controlled, randomized, brazil, nitazoxanide, hospitalized patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Brazil, National Research Council, Brazil, Financiadora de Estudos e Projetos, ATCGen, Hospital Central da Aeronáutica, Rio de Janeiro, Hospital da Força Aérea do Galeão, Hospital Naval Marcilio Dias, Hospital Universitario Pedro Ernesto, Hospital de Força Aérea de São Paulo, Hospital das Clínicas Luzia de Pinho Melo, Complexo Hospitalar Municipal de São Caetano do Sul, Hospital Municipal de Barueri Dr Francisco Moran, Hospital Regional de Sorocaba Dr Adib Domingos Jatene, Hospital Geral de São Mateus Dr Manoel Bifulco, Santa Casa de Misericórdia de Belo Horizonte, Mater Dei Hospital, Brazil, Hospital Eduardo de Menezes, Hospital das Clínicas da Universidade Federal de Pernambuco, Hospital das Forças Armadas, Brazil, Hospital Regional da Asa Norte, Brazil, Complexo Hospitalar do Trabalhador de Curitiba, Hospital Estadual de Doenças Tropicais Dr Anuar Auad, Hospital Geral de Fortaleza
- Study start
- 19 Apr 2020 (actual)
- Primary completion
- 2 Oct 2020 (actual)
- Study completion
- 2 Oct 2020 (actual)
- First posted
- 23 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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),
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Nitazoxanide | Experimental | Drug: NitazoxanidePatients received nitazoxanide 500mg 8/8hours, for 5 days. |
| Placebo | Placebo comparator | Drug: PlaceboPatients received placebo 500mg 8/8hours, for 5 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients requiring supplemental oxygen [peripheral oxygen saturation (SpO2) < 93%], admitted to hospital with COVID-19 symptoms associated with chest computed tomography (CT) scan suggestive of viral pneumonia or positive nasopharyngeal swab test for SARS-CoV2 (RT-PCR)
- Age equal or superior to 18 years
- Non-pregnant women
- Willingness to receive study treatment
- Providing written and informed consent or the same consent signed by a family member
Key exclusion criteria (10 listed)
- Impossibility to use oral medications
- History of severe liver disease (Child Pugh C class)
- Previous renal failure
- Severe heart failure (NYHA 3 or 4)
- COPD (GOLD 3 and 4)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NitazoxanideAlso: annita, azox, irose, taniseaNitazoxanide 500mg three times a day for 5 days | Drug | Nitazoxanide |
| PlaceboPlacebo three times a day for 5 days | Drug | Placebo |
Primary outcome
Orotracheal intubation rate
Time frame: 14 days
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.
45 secondary outcomes
Hospitalisation days
Time frame: 14 days
ICU days
Time frame: 14 days
Intranasal oxygen support days
Time frame: 14 days
Mortality rate
Time frame: 14 days
Days with fever
Time frame: 14 days
Days with cough
Time frame: 14 days
Days with dyspnea
Time frame: 14 days
Radiologic findings
Time frame: Day1
Radiologic findings
Time frame: Day7
Cardiologic findings
Time frame: Day1
Cardiologic findings
Time frame: Day7
C-reactive protein - absolute number
Time frame: Day 1
C-reactive protein serum levels
Time frame: Day 3
C-reactive protein serum levels
Time frame: Day 7
Lactate dehydrogenase (LDH) serum levels
Time frame: Day 1
Lactate dehydrogenase (LDH) serum levels
Time frame: Day 3
Lactate dehydrogenase (LDH) serum levels
Time frame: Day 7
Troponin serum levels
Time frame: Day 1
Troponin serum levels
Time frame: Day 3
Troponin serum levels
Time frame: Day 7
Electrolytes serum levels
Time frame: Day 1
Electrolytes serum levels
Time frame: Day 3
Electrolytes serum levels
Time frame: Day 7
Glucose serum levels
Time frame: Day 1
Glucose serum levels
Time frame: Day 3
Glucose serum levels
Time frame: Day 7
Renal function
Time frame: Day 1
Renal function
Time frame: Day 3
Renal function
Time frame: Day 7
Coagulogram
Time frame: Day 1
Coagulogram
Time frame: Day 3
Coagulogram
Time frame: Day 7
Liver function panel
Time frame: Day 1
Liver function panel
Time frame: Day 3
Liver function panel
Time frame: Day 7
Ferritin
Time frame: Day 1
Ferritin
Time frame: Day 3
Ferritin
Time frame: Day 7
D-dimer
Time frame: Day 1
D-dimer
Time frame: Day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Background: PubMed 27095301Rossignol 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: PubMed 25108173Rossignol 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: PubMed 32511548Rajoli 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: PubMed 32405422Pepperrell 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.
- Derived from this study: PubMed 40385586Conceicao 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.
- Derived from this study: PubMed 37261117Silva 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.
- Derived from this study: PubMed 35492335Rocco 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.
- Individual participant dataSharing planned: Yes. The investigators plan on sharing all IPD that underlie results in a publication for editorial board, with cautious of not sharing confidential data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro L Silva, PhD study chair
Universidade Federal do Rio de Janeiro
Patricia RM Rocco, MD, PhD principal investigator
Universidade Federal do Rio de Janeiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nitazoxanide in people with Covid19 and Corona Virus Infection, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orotracheal intubation rate (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04561219, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2021; AzTrials last refreshed its copy on 7 Nov 2026.