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Publication Mahmud R, Unpublished, 2020 (preprint)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 criteria18 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 criteriaUnable 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.