Trial NCT04523831
Publication Mahmud R, J Int Med Res, 2021 (published paper)
Dates: 2020-06-01 to 2020-08-30
Funding: No specific funding (No specific grant)
Conflict of interest: No
| Methods | |
| RCT Blinding: double blinding | |
| Location :
Single center / Bangladesh Follow-up duration (days): 30 | |
| Inclusion criteria | 18 years and older; COVID-19 infection, confirmed by polymerase chain reaction (PCR) test within 3 days prior enrollment; Only mild and moderate COVID-19 infected cases; Able to provide informed consent |
| Exclusion criteria | Unable to take oral medication; Pregnant or breast feeding lady; Patients with severe COVID symptoms(defined as tachypnea [>30 breaths/minute] and hypoxia [oxygen saturation(SpO2) <90%] requiring supplemental oxygen), or admission in ICU/HDU; Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) more than 5 upper limit of normal (ULN);Known hypersensitivity to Doxycycline or ivermectin or its components; Registry: non-invasive positive pressure ventilation or mechanical ventilation at time of study entry |
| Interventions | |
| Treatment
Ivermectin+Doxycycline Ivermectin : 12 mg orally once off. Doxycycline : 100 mg orally twice a day for 5 days. |
|
| Control
Placebo Duration : 5 days | |
| Participants | |
| Randomized 400 participants (n1=200 / n2= 200) | |
| Characteristics of participants N=400 Mean age : 39.6 235 males Severity : Mild: n=* / Moderate: n=*/ Severe: n=* Critical: n=* | |
| Primary outcome | |
| In the register Number of Patients With Early Clinical Improvement [ Time Frame: 7 days ]; Number of Participants With Late Clinical Recovery [ Time Frame: 12 days ] | |
| In the report Number of days required for clinical recovery from day 1 | |
| Documents available |
Protocol Yes. In English Statistical plan Yes 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 |
In addition to the published article, the study registry (retrospective), protocol and statistical analysis plan (retrospective) was used in data extraction and risk of bias assessment. Outcomes for adverse and serious adverse events were extracted from the result section of the study registry.Target sample size specified in the registry and protocol was achieved. There is no change from the trial registration or protocol in the intervention and control treatments or in the outcomes. However, the study registry and protocol were retrospective and therefore interpreted with caution. Denominators for SAEs/withdrawal due to AEs and Mortality do not seem to include the participants with these outcomes.
On 19th of May, 2021, this study was updated based on the published report. |