Trial NCT04438850
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

Methods
RCT
Blinding: double blinding
Location : Multicenter / Italy
Follow-up duration (days): 30
Inclusion criteria
  • Above 18 years old
  • Newly diagnosed with SARS-CoV-2 infection with a Real-Time PCR analysis of nasopharyngeal swabs
  • Not requiring hospitalization or oxygen supplementation (COVID-19 severity score < 3)
  • Providing their informed consent to the study.
Exclusion criteria
  • Pregnant or lactating
  • Known Central Nervous System disease
  • Participants under dialysis
  • Any severe medical condition with a prognosis of < 6 months
  • Warfarin treatment
  • Antiviral treatment
  • Chloroquine phosphate or hydroxychloroquine treatment.
Interventions
Treatment
Ivermectin 600
600 mcg/kg once daily orally for 5 days

Ivermectin 1200
1200 mcg/kg once daily orally for 5 days
Control
Placebo

Participants
Randomized
participants :
Ivermectin 600=29
Ivermectin 1200=32
Placebo=32
Characteristics of participants
N= 93
Mean age : NR
54 males
Severity : Mild: n= */ Asymptomatic: n=*
Number of vaccinated participants: 1
Primary outcome
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
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:

Yes
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 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.