Trial NCT04529525
Publication Vallejos J, BMC Infect Dis, 2021 (published paper)
Dates: 2020-08-19 to 2021-02-22
Funding: No specific funding (None)
Conflict of interest: No
| Methods | |
| RCT Blinding: double blinding | |
| Location :
Single center / Argentina Follow-up duration (days): 42 | |
| Inclusion criteria | Over 18 years of age; residing in the province of Corrientes at the time of diagnosis with confirmed COVID-19; diagnosis by RT-PCR (CFX96 qPCR, Bio-Rad) for SARS-CoV2 detection in the last 48 h; women of childbearing age should be using a contraceptive method of proven efficacy and safety; to weigh at the time of inclusion equal to or greater than 48 kg |
| Exclusion criteria | Required current home oxygen use or required hospitalization for COVID-19 at the time of diagnosis; a history of hospitalization for COVID-19; pregnant or breastfeeding women; known allergy to ivermectin or the components of ivermectin or placebo tablets; presence of mal-absorptive syndrome; presence of any other concomitant acute infectious disease; known history of severe liver disease and recent or expected need for dialysis; concomitant use of hydroxychloroquine or chloroquine or antiviral drugs due to a viral pathology other than COVID-19 at the time of admission; use of ivermectin up to 7 days before randomization; participation in a research study that involved the administration of a drug within the last 30 days |
| Interventions | |
| Treatment
Ivermectin Dose staggered by weight: Initial dose: 12 mg (<80 Kg), 18 mg (80-110 kg), or 24 mg (>110 kg) orally first day Maintenance dose: 12 mg (<80 Kg), 18 mg (80-110 kg), or 24 mg (>110 kg) orally once a day for 2 days |
|
| Control
Placebo | |
| Participants | |
| Randomized 501 participants (n1=250 / n2= 251) | |
| Characteristics of participants N=501 Mean age : 42.5 264 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=0 | |
| Primary outcome | |
| In the register Percentage of Hospitalization of medical cause in patients with COVID-19 in each arm [ Time Frame: through study completion, an average of 30 days ] | |
| In the report Hospitalization for any reason of patients with COVID-19 | |
| Documents available |
Protocol Yes. In English Statistical plan Yes 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 |
Low |
| General comment |
In addition to the published article with supplementary materials, the study registry and protocol were used in data extraction and risk of bias assessment. The study achieved the target sample size specified in the trial registry. There is no change from the trial registration in the intervention and control treatments. The primary outcome indicated in registry reflects the primary outcome reported in the paper. Time to death and time to WHO score 7 and above was based on a 12 (+-3) days follow up.
On 30th July, 2021, we received additional information from authors on this study. This study was updated with data from contact with authors and the published report on August 16th, 2021. |