Trial NCT04403555
Publication Abd-Elsalam S, J Med Virol (2021) (published paper)
Dates: 2020-03-01 to 2020-10-30
Funding: Not reported/unclear
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Multicenter / Egypt
Follow-up duration (days): 30
Inclusion criteria
  • adult patients from ages 20 to 65
  • mildly to moderately affected COVID-19 infection confirmed by pharyngeal swab polymerase chain reaction
Exclusion criteria
  • allergy or contraindication to the drugs used in the study
  • pregnant and lactating mothers
  • patients with cardiac problems
Interventions
Treatment
Ivermectin
12 mg per day orally for 3 days

Control
Standard care

Participants
Randomized
participants :
Ivermectin=82
Standard care=82
Characteristics of participants
N= 164
Mean age : NR
82 males
Severity : Mild: n=* / Moderate: n=* / Severe: n=* Critical: n=*
Number of vaccinated participants: NR
Primary outcome
In the register
The number of patients with resolved viral infection [Time Frame: 6 months] (2020-05-23) The number of patients with mortality [Time Frame: 1 month] (2021-03-03)
In the report
All-cause mortality within 1 month after randomization
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:

Not reported
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 published article, the trial registry was used in data extraction and risk of bias assessment. Neither protocol not statistical analysis plan was available. The trial was first registered during the conduct of the study. There were substantial changes to methods during and after the conduct of the study from the initial trial registration to the final registration and report. The sample size was reduced. Intervention and control treatments changed from ivermectin with doxycycline compared with chloroquine to ivermectin compared with standard care. The ivermectin dosage was changed. The primary outcome changed from resolved viral infection to mortality, and additional outcomes were added after the study had been completed.