Trial ChiCTR2000033627
Publication Samaha A,, Viruses (2021) (published paper)
Dates: 2020-09-01 to 2020-11-30
Funding: No specific funding (This research received no external funding)
Conflict of interest: No

Methods
RCT
Location : * / Lebanon
Follow-up duration (days): 3
Inclusion criteria
  • Adult subjects
  • Weight is ≥45 kg
  • SARS-CoV-2-positive based on a PCR result showing a Ct value below 20.
Exclusion criteria
  • Lactating or pregnant
  • History of allergy to a component of the used medication
  • End-stage kidney or liver diseases
  • Pulmonary fibrosis
  • Advanced COPD
  • Heart failure NYHA class IV
  • Recent cardiac intervention (less than two months).
Interventions
Treatment
Ivermectin
45–64 kg, 65–84 kg, or above 85 kg received 9 mg, 12 mg, or 150 μg/kg body weight orally once-off
Control
Standard care

Participants
Randomized
participants :
Ivermectin=50
Standard care=50
Characteristics of participants
N= 100
Mean age : NR
50 males
Severity : Mild: n= 0/ Asymptomatic: n=100
Number of vaccinated participants: NR
Primary outcome
In the register
Reduction of viral load and treating COVID-19 infection
In the report
NR
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 RETRACTED**** In addition to the published article, the prospective trial registry (dated 2020-06-07) was used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. In the prospective registry the control group is reported as receiving a placebo (inferring blinding), but this is not reported in the article. Blinding is not reported in the article or the registry. In the registry, recruitment was indicated in all hospitals dealing with COVID-19 in Beqaa, Lebanon, and Baghdad, Iraq; the article only reports on a study in Lebanon. The study was reported as being conducted in June/July 2020 in the registry, but September-November 2020 in the article. The study achieved its pre-specified target sample size. The primary outcome indicated in registry does not reflect the primary outcome reported in the paper. Adverse events are not reported.