Trial NCT04429711
Publication Biber A, medRxiv, 2021 (preprint)
Dates: 2020-05-15 to 2021-01-30
Funding: No specific funding (None)
Conflict of interest: No
| Methods | |
| RCT Blinding: double blinding | |
| Location :
Multicenter / Israel Follow-up duration (days): 14 | |
| Inclusion criteria | 18 years of age or older; not pregnant; with molecular confirmation of COVID-19 by RT-PCR up to seven days from symptoms onset (symptomatic cases were also included within 5 days from molecular diagnosis) |
| Exclusion criteria | weight below 40kg; known allergy to the drugs; unable to take oral medication; participating in another RCT for treatment of COVID-19; patients who had RT-PCR results with Ct (cycle threshold) value >35 in first two consecutive; patients with comorbidities of cardiovascular disease, diabetes, chronic respiratory disease (excluding mild intermittent asthma), hypertension, and or cancer were defined as high-risk patients; severe infection (defined as need for invasive or non-invasive ventilator support, ECMO, or shock requiring vasopressor support)(regsitry) |
| Interventions | |
| Treatment
Ivermectin Weight 40-69 kg = 12mg orally once a day for 3 days; weight ≥70kg =15mg orally once a day for 3 days |
|
| Control
Placebo | |
| Participants | |
| Randomized 116 participants (n1=57 / n2= 59) | |
| Characteristics of participants N=116 Mean age : NR 69 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=0 | |
| Primary outcome | |
| In the register Viral clearance at day 6 [Time Frame: Outcome will be determined till 6 days post intervention] | |
| In the report Viral clearance following a diagnostic swab taken on the sixth day (third day after termination of treatment) | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated
|
| 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 pre-print article, the trial registry (dated June 12 2020) was used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. Due to delays in test results in the community, the inclusion criteria relating to time from testing to inclusion were slightly different in the report than in the registry in terms of time from symptom onset to testing. Some changes were made to the testing timepoints during the trial due to changes in national policies on discharge from isolation. The study achieved its target sample size. The registry was retrospective. The registry primary outcome reflects that reported in the preprint, however, the secondary outcomes reported in the registry (symptom clearance time, viral shedding duration) were not reported. |