Trial NCT04523831
Publication Mahmud R, Unpublished, 2020 (preprint)
Dates: 2020-06-01 to 2020-09-10
Funding: Mixed (Dhaka Medical College, Popular pharmaceutical provided drugs and the placebo)
Conflict of interest: *
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 from 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 or admission in ICU/HDU; Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) more than 5 upper limit of normal (ULN); On non-invasive positive pressure ventilation or mechanical ventilation at time of study entry; Known hypersensitivity to Doxycycline or ivermectin or its components |
Interventions | |
Treatment
Ivermectin+Doxycycline (12 mg/100 mg)Co-Intervention: Standard care Duration : 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=0 Critical: n=0 | |
Primary outcome | |
In the register No | |
In the report NR | |
Documents avalaible |
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 |
High |
General comment | At the time of data collection and risk of bias assessment, there was no published report, data were collected from the online trial registry, protocol and statistical analysis plan. 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. Denominators for SAEs/withdrawal due to AEs and Mortality do not seem to include the participants with these outcomes. |