Publication SAINT - Chaccour C, EClinicalMedicine (2021) (published paper)
Dates: 2020-07-31 to 2020-09-11
Funding: Mixed (ISGlobal; University of Navarra. Unitaid; Spanish Ministry of Science and Innovation; Generalitat de Catalunya; Idipharma SL (placebo donation))
Conflict of interest: No
Single center / Spain |
Follow-up duration (days): 28
400 mcg/kg orally once off.
|Characteristics of participants|
Mean age : NR
Severity : Mild: n= 24/ Asymptomatic: n=0
Number of vaccinated participants: NR
|In the register|
Proportion of patients with a positive SARS-CoV-2 PCR from a nasopharyngeal swab at day 7 post-treatment
|In the report|
Proportion of patients with detectable SARS-CoV-2 RNA by PCR from nasopharyngeal swab at day 7 post-treatment
Yes. In English
Data-sharing willing stated in the publication:
|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 article, the supplementary appendices, the study registry, protocol and data analysis plan were used in data extraction and risk of bias assessment. There were no substantive differences between the pre-print article and the trial registry, study protocol and statistical analysis plan in population, procedures, interventions or outcomes. The study achieved its stated sample size.
Quote: "The placebo tablets did not match ivermectin in appearance, therefore, in order for the clinical team to remain blinded, treatment was administered under direct supervision by a nurse not participating in patient´s care. There was slow recruitment due to a sharp reduction in local transmission for 10 weeks after the lockdown of March-April 2020, the protocol was amended on September 2nd to extend the inclusion criteria from 48 to a maximum of 72 hours of cough or fever."
This study was updated on January 28th, 2021 after publication of the study report.