Trial NCT04407130
Publication Ahmed S, 2020 (published paper)
Funding: Private (Beximco Pharmaceutical Limited, Bangladesh)
Conflict of interest: No
| Methods | |
| RCT Blinding: double blinding | |
| Location :
* / Bangladesh Follow-up duration (days): 28 | |
| Inclusion criteria | age 18-65 years; admitted to hospital within the last 7 days; with either fever (â¥37.5C); cough or sore throat; and diagnosed positive for SARS-CoV-2 by rRT-PCR |
| Exclusion criteria | allergic to or potential drug-drug interaction for ivermectin or doxycycline; chronic illnesses (e.g., ischemic heath disease, heart failure, documented cardiomyopathy, chronic kidney disease, chronic liver disease); received ivermectin and/or doxycycline in the last 7 days; were pregnant or lactating; or participated in any other clinical trial within the last month |
| Interventions | |
| Treatment 1 Ivermectin+Doxycycline ( 12 mg/100 mg) Co-Intervention: Standard care Duration : 5 days | |
| Control Placebo | |
| Control Ivermectin (12 mg) Co-Intervention: Standard care Duration : 5 days | |
| Participants | |
| Randomized 72 participants n1=24/ n2=24/ n3=24 | |
| Characteristics of participants N=72 Mean age : 41.7 33 males Severity : Mild: n=72 / Moderate: n=0/ Severe: n=0 Critical: n=0 | |
| Primary outcome | |
| In the register 1.Virological clearance [ Time Frame: within 7 days after enrollment ] 2.Remission of fever [ Time Frame: within 7 days after enrollment ] 3.Remission of cough [ Time Frame: within 7 days after enrollment ] | |
| In the report Time required for virological clearance (a negative rRT-PCR result on nasopharyngeal swab); remission of fever (≥37.5C) and cough within 7 days | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated NR |
| 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 |
The published article and the regsitry were used in data extraction and assessment of risk of bias. No study protocol or statistical analysis plan were available. 4/72 participants withdrew consent because of family obligations and unwillingness to be tested further. Baseline characteristics were not reported by study group. Some efficacy outcomes were not reported in the results section of the paper although they were listed in the methods section. Mortality, reported as a study outcome in the methods, was not clearly reported.
This study was updated on February 2nd, 2021 after contact with authors. |