Trial NCT04552483
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
Methods | |
RCT Blinding: | |
Location :
Multicenter / Brazil Follow-up duration (days): 14 | |
Inclusion criteria |
|
Exclusion criteria |
|
Interventions | |
Treatment
Nitazoxanide 500 mg orally three times a day for 5 days |
|
Control
Placebo | |
Participants | |
Randomized participants : Nitazoxanide =238 Placebo=237 | |
Characteristics of participants N= 475 Mean age : NR 184 males Severity : Mild: n= 475/ Asymptomatic: n=0 Number of vaccinated participants: NR | |
Primary outcome | |
In the register Days with fever; Days with cough; Days with asthenia [ Time Frame: Day8 ] | |
In the report Complete resolution of symptoms | |
Documents available |
Protocol Yes. In English Statistical plan Yes Data-sharing willing stated in the publication:
|
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
Some concerns |
General comment |
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. |