Effects of Early Use of Nitazoxanide in Patients With COVID-19
NCT ID: NCT04552483
Last Updated: 2020-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
392 participants
INTERVENTIONAL
2020-06-08
2020-09-05
Brief Summary
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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.
Detailed Description
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Experimental group: 196 patients received nitazoxanide 500mg 8 / 8 hours for 5 days. Control group: 196 patients received placebo 8/8 hours for 5 days.
Population: 392 Patients with COVID-19, confirmed by RT-PCR (Real Time polymerase chain reaction), symptomatic in the early phase of the disease.
Calculation of the sample size was based on a previous study which demonstrated that 78% of Covid-19 patients in group 4 (Hospitalized without oxygen therapy), according to the WHO ordinal classification, experienced complete resolution of symptoms after receiving placebo.10 In the present trial, patients were classified as group 2 (Symptomatic and independent), and a greater degree of recovery as measured by symptom-free days (80%) was expected even after placebo. Thus, assuming an 11% increase in symptom-free days in those patients who would receive nitazoxanide compared to placebo, we would need approximately 196 patients per experimental group, admitting a beta error of 15% and alpha error of 5%, for a total n of 392 patients. Calculation of the sample size was done by G\*Power 3.1.9.2 (Universität Düsseldorf, Düsseldorf, Germany).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Experimental group: 196 patients diagnosed with COVID-19 confirmed by RT-PCR will receive nitazoxanide 500mg 8/8 hs for 5 days. Control group: 196 patients diagnosed with COVID-19 confirmed by RT-PCR will receive placebo 8/8 hs for 5 days.
TREATMENT
DOUBLE
Study Groups
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Nitazoxanide
Patients received nitazoxanide 500mg 8/8hours, for 5 days.
Nitazoxanide
Nitazoxanide 500mg 8/8 hours for 5 days in the early clinical phase of COVID-19.
Placebo
Patients received placebo 500mg 8/8hours, for 5 days.
Placebo
Placebo 8/8 hours for 5 days in the early clinical phase of COVID-19.
Interventions
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Nitazoxanide
Nitazoxanide 500mg 8/8 hours for 5 days in the early clinical phase of COVID-19.
Placebo
Placebo 8/8 hours for 5 days in the early clinical phase of COVID-19.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Beginning 1 to 3 days before inclusion in the study
* Age equal or superior to 18 years
* Willingness to receive study treatment
* Providing written and informed consent or the same consent signed by a family member
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Ministry of Science and Technology, Brazil
OTHER
National Research Council, Brazil
OTHER
ATCGen
UNKNOWN
Complexo Hospitalar Municipal de São Caetano do Sul
UNKNOWN
Hospital de Transplante Doutor Euryclides de Jesus Zerbini
OTHER
Secretaria Municipal de Saúde de Bauru
UNKNOWN
Santa Casa de Misericórdia de Sorocaba
UNKNOWN
Secretaria Municipal de Saúde de Guarulhos
UNKNOWN
Hospital e Maternidade Therezinha de Jesus
UNKNOWN
Secretaria de Estado de Saúde do Distrito Federal
UNKNOWN
Universidade Federal do Rio de Janeiro
OTHER
Responsible Party
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Jose Roberto Lapa e Silva
Clinical Investigator
Principal Investigators
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Patricia RM Rocco, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidade Federal do Rio de Janeiro
Locations
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Universidade Federal do Rio de Janeiro
Rio de Janeiro, , Brazil
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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RBR-4nr86m
Identifier Type: OTHER
Identifier Source: secondary_id
32258920.0.1001.5257
Identifier Type: OTHER
Identifier Source: secondary_id
SARITA-2
Identifier Type: -
Identifier Source: org_study_id