Trial NCT04392713
Publication Shah Bukhari K H, medRxiv (2021) (preprint)

Funding: Not reported/unclear ("Not applicable")
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Single center / Pakistan
Follow-up duration (days): 28
Inclusion criteria
  • 15-65 years
  • any gender
  • COVID-19 positive, proven by RT-PCR
  • Mild (fever <38oC quelled without treatment with or without cough, no dyspnea, no gasping, no chronic disease, no imaging findings of pneumonia) to moderate (fever, respiratory symptoms, imaging findings of pneumonia) severity of the disease
  • consent for trial, stated their willingness to comply with all study procedures, agreed for admission for the trial period (14 days)
  • able to take oral medication
Exclusion criteria
  • Positive pregnancy test (all females were tested)
  • severe symptoms likely due to cytokine release syndrome
  • uncontrolled co-morbidities
  • malignant diseases
  • diabetes mellitus
  • chronic kidney disease
  • cirrhosis liver with CPT class B or C
  • immunocompromised
  • history of ivermectin allergy
  • patients taking CYP 3A4 inhibitors or inducers
  • oxygen requirements equivalent to FiO2 ≥50% in moderate severity patients
Interventions
Treatment
Ivermectin
12 mg, once-off dose on admission

Control
Standard care

Participants
Randomized
participants :
Ivermectin=50
Standard care=50
Characteristics of participants
N= 100
Mean age : NR
73 males
Severity : Mild: n=100 / Moderate: n=0 / Severe: n=0 Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Negative PCR [ Time Frame: 144 hours ] - PCR will be done at 48, 96 and 144 hours
In the report
The primary end-point of the study was viral clearance and was measured as the days to achieve RT-PCR negativity following ivermectin administration.
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
High
General comment In addition to the pre-print article, the trial registry was used in data extraction and assessment of risk of bias. The trial was registered retrospectively while the trial was ongoing. Neither study protocol nor statistical analysis plan was available. There are some differences between the pre-print article and the trial protocol in exclusion criteria relating to comorbidities. Standard care was different between the registry (chloroquine) and the report (vitamin C, paracetamol). The primary outcome timepoints differ between the registry and the pre-print article. The secondary outcome in the registry (need for ventilation) was not reported in the pre-print article. The pre-print reported that there were no adverse drug reactions in the ivermectin arm (not listed as an outcome in the registry). The target sample size specified in the registry was achieved. The study was assessed to be at a high risk of bias due to some concerns in multiple domains.