Trial NCT04668469
Publication Elgazzar A, 2020
Funding: No specific funding (No Funding/Support)
Conflict of interest:
| Methods | |
| *RCT | |
| Location :
Multicenter / Egypt Follow-up duration (days): 14 | |
| Inclusion criteria | healthcare (pre exposure) and/or household (post exposure) patientsÂ’ contacts of confirmed, symptomatic COVID-19 cases; 18 years up to 80 years old; not participating in other clinical trials within 30 days from administration of the study drugs. |
| Exclusion criteria | pregnancy; lactation |
| Interventions | |
| Treatment
Ivermectin (*)Co-Intervention: Standard care Duration : 8 days |
|
| Control
Standard care Definition of Standard care: Personal protective measures (PPM): hand hygiene, social distance measures, avoiding touching the eyes, nose, and, face masks, gloves, respiratory etiquette and self-isolation Duration : 2 weeks | |
| Participants | |
| Randomized 200 participants (n1=100 / n2= 100) | |
| Characteristics of participants N=200 Mean age : 57.2 147 males | |
| Primary outcome | |
| In the register COVID-19 disease | |
| In the report | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated 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 | This report was extracted as 3 RCTs; the report and registry cover both treatment and prevention groups, with sparse information provided on the prevention RCT. In addition to the pre-print article, the study registry was used in data extraction and risk of bias assessment. The trial was registered after the study was completed. A participant flow diagram was not presented. The method of analysis was not reported. There were no other substantive differences between the registry and pre-print in study population, procedures, or interventions. Overall the study was not clearly reported. |