Publication COVER - Buonfrate D, Int J Antimicrob Agents (2022) (published paper)
Dates: 2020-07-31 to 2021-06-10
Funding: Public/non profit (Italian Ministry of Health; Tablets of 9 mg ivermectin and of placebo were donated by Insud Pharma, Madrid.)
Conflict of interest: No
Blinding: double blinding
Multicenter / Italy |
Follow-up duration (days): 30
600 mcg/kg once daily orally for 5 days
1200 mcg/kg once daily orally for 5 days
|Characteristics of participants|
Mean age : NR
Severity : Mild: n= */ Asymptomatic: n=*
Number of vaccinated participants: 1
|In the register|
1) SADR [ Time Frame: 14 days ] Number of serious adverse drug reaction; 2) Viral load [ Time Frame: Assessed at day 7 ] Quantitative viral load as measured by quantitative, digital droplet PCR
|In the report|
1) Nmber of SADRs; 2) Change in viral load at Day 7 with respect to baseline. at Day 7
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 study registry was used in data extraction and risk of bias assessment. The primary outcome indicated in registry reflects the primary outcome reported in the paper. The protocol was not available though mentioned in the article to be included in the supplementary appendix. The recruitment was stopped on 10th June, because of a dramatic drop of cases.
Incidence of viral negative conversion outcome was reported for a timeframe within 14 days, hence likely cumulative.
This study was updated on April 11th 2022, with data from the peer-reviewed publication.