Trial NCT04920942
Publication I-TECH - Lim SCL, JAMA Intern Med (2022) (published paper)
Dates: 2021-05-31 to 2021-10-09
Funding: Not reported/unclear
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Multicenter / Malaysia
Follow-up duration (days): 28
Inclusion criteria
  • Patients with reverse transcriptase–polymerase chain reaction (RT-PCR) test–confirmed or antigen test–confirmed COVID-19
  • 50 years or older
  • with at least 1 comorbidity
  • presented with mild to moderate illness (Malaysian COVID-19 clinical severity stage 2 or 3
  • WHO clinical progression scale 2-4)
  • within 7 days from symptom onset
Exclusion criteria
  • Asymptomatic
  • required supplemental oxygen
  • pulse oximetry oxygen saturation (SpO2) level less than 95% at rest
  • severe hepatic impairment (alanine transaminase level >10 times of upper normal limit)
  • acute medical or surgical emergency
  • concomitant viral infection
  • pregnancy or breastfeeding
  • warfarin therapy
  • history of taking ivermectin or any antiviral drugs with reported activity against COVID-19 (favipiravir, hydroxychloroquine, lopinavir, and remdesivir) within 7 days before enrollment
Interventions
Treatment
Ivermectin
0.4 mg/kg/day orally for 5 days
Control
Standard care

Participants
Randomized
participants :
Ivermectin=250
Standard care=250
Characteristics of participants
N= 500
Mean age : NR
223 males
Severity : Mild: n=490 / Moderate: n=0 / Severe: n=0 Critical: n=0
Number of vaccinated participants: 124
Primary outcome
In the register
1) Number of Patients who Progressed to Severe Disease (Clinical stage 4 or 5) [ Time Frame: Within 28 days since administered Ivermectin ]; 2) Time Required for Patients on Treatment Arm to Progressed to Severe Disease (Clinical stage 4 or 5) [ Time Frame: Within 28 days since administered Ivermectin ]
In the report
The proportion of patients who progressed to severe COVID-19, defined as the hypoxic stage requiring supplemental oxygen to maintain Spo2 95% or greater (Malaysian COVID-19 clinical severity stages 4 or 5; WHO clinical progression scale 5-9)
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

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 published article, the trial registry, protocol, statistical analysis plan and supplementary appendices were used in data extraction and assessment of risk of bias. The primary and secondary outcomes in the article reflect those in the registry and/or protocol. The study (n = 500) achieved its target sample size (n = 500). There is no change from the trial registration in the intervention and control treatments.