Trial NCT04523831
Publication Mahmud R, J Int Med Res (2021) (published paper)
Dates: 2020-06-01 to 2020-08-30
Funding: drug donation only (No specific grant; "Popular Pharmaceuticals Bangladesh Limited for supplying the study intervention and personal protective equipment")
Conflict of interest: No

Methods
RCT
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
IVM+DX
Ivermectin : 12 mg orally once off.
Doxycycline : 100 mg orally twice a day for 5 days.
Control
Placebo

Participants
Randomized
participants :
IVM+DX =200
Placebo=200
Characteristics of participants
N= 400
Mean age : NR
235 males
Severity : Mild: n=* / Moderate: n=* / Severe: n=* Critical: n=*
Number of vaccinated participants: NR
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 willing stated in the publication:

Not reported
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.