Trial CTRI/2020/06/026001
Publication RIVET-COV - Mohan A, J Infect Chemother (2021) (published paper)
Dates: 2020-07-28 to 2020-09-29
Funding: Mixed (Department of Science and Technology, Government of India; WindLas BioTech Ltd. Haryana (drug contribution))
Conflict of interest: No

Methods
RCT
Blinding: Participants, outcome assessor and health care pro
Location : Single center / India
Follow-up duration (days): 28
Inclusion criteria
  • - Aged 18 years or above

  • - Diagnosed (based on a positive result on either SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) or the rapid antigen test)
    - Non-severe COVID-19 (i.e. room air saturation (SpO2) >90%, no hypotension or requirement of mechanical ventilation)
Exclusion criteria
  • - If they did not give informed consent
    - Pregnancy or lactation
    - Known hypersensitivity to ivermectin
    - Chronic kidney disease with creatinine clearance <30 mL/min
    - Elevated transaminase levels (>5 x upper limit of normal)
    - Myocardial infarction or heart failure within 90 days prior to enrolment
    - Prolonged corrected QT interval (>450 ms) on electrocardiogram
    - Any other severe comorbidity as per investigator’s assessment
    - Enrolment in a concomitant clinical trial
Interventions
Treatment
Ivermectin 12 mg
12 mg orally, single dose

Ivermectin 24 mg
24 mg orally, single dose
Control
Placebo

Participants
Randomized
participants :
Ivermectin 12 mg=52
Ivermectin 24 mg=52
Placebo=53
Characteristics of participants
N= 157
Mean age : NR
111 males
Severity : Mild: n=115 / Moderate: n=10 / Severe: n=0 Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Frequency of RT-PCR negativity at day 5 after drug administration; Change in viral load (as determined by RTPCR cycle threshold) at day 5 as compared to baseline
In the report
Reduction of viral load and conversion to negativity of nasopharyngeal/oropharyngeal RT-PCR on day 5 after intervention
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 journal and pre-print article, the study registry and supplementary materials were used in data extraction and risk of bias assessment. It is not clear what the target sample size was and if it was achieved. Outcomes were not reported in the study registry, so it is unclear if there were reported at the correct follow-up point. There is no change from the study registration in the intervention and control treatments.
This trial was updated on September 27th, 2021 with data from the peer-reviewed journal publication.