Publication Rocco PRM, Eur Respir J, 2020 (published paper)
Dates: 2020-06-08 to 2020-08-20
Funding: Mixed (Brazilian Council for Scientific and Technological Development (CNPq), Brazilian Ministry of Science, Technology, and Innovation for Virus Network; Brasilia, Brazil, and Funding Authority for Studies and Projects, Brasil)
Conflict of interest: Yes
Blinding: double blinding
Multicenter / Brazil |
Follow-up duration (days): 14
|Inclusion criteria||1. Patients with one or more of three selected symptoms of Covid-19 (fever and/or dry cough and/or fatigue) of 1 to 3 days’ duration.
2. Age 18 years of age or older.
3. Willingness to take the study therapy.
4. Provision of written informed consent (by patient or a health care surrogate).
|Exclusion criteria||1. Negative result on RT-PCR for SARS-CoV-2 in a nasopharyngeal swab specimen collected at admission.
2. Inability to swallow.
3. History of severe liver disease.
4. Chronic kidney disease requiring renal replacement therapy.
5. Severe heart failure (NYHA class 3 and class 4).
6. Severe chronic obstructive pulmonary disease (COPD) (GOLD 3 and 4).
7. Any cancer in the last 5 years.
8. Any known autoimmune disease.
9. Known allergy to nitazoxanide.
10. Nitazoxanide treatment in the last 30 days.
11. Clinical suspicion of tuberculosis or bacterial pneumonia.
500 mg orally three times a day for 5 days
Duration : 5 days
475 participants (n1=238 / n2= 237)
|Characteristics of participants|
Mean age : 37.8
Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=0
|In the register|
Days with fever; Days with cough; Days with asthenia [ Time Frame: Day8 ]
|In the report|
Complete resolution of symptoms
Yes. In English
|Risk of bias
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
In addition to the pre-print, the study registry and supplementary materials were used in data extraction and risk of bias assessment. Study protocol and statistical analysis plan were not available at the time of data extraction. Trial registration was retrospective. Sample size justification was calculated retrospectively to describe power of the included sample size following considerable loss to follow up. The registry primary outcomes and timepoint does not reflect the combined reported primary outcome. Data for the outcome Viral negative conversion Day 7 correspond to day 5 in the trial.
This study was updated on December 3rd, 2020 after contact with authors.
This study was updated on January 18th, 2021 after publication of the study report.