Trial PACTR202108891693522
Publication Babalola O, J Infect Dis Epidemi (2021) (published paper)
Dates: 2021-05-02 to 2021-06-11
Funding: Public/non profit (Central Bank of Nigeria Healthcare Sector Research and Development Intervention Scheme (HSRDIS))
Conflict of interest: *

Methods
RCT
Blinding: single blinding
Location : Single center / Nigeria
Follow-up duration (days): 21
Inclusion criteria
  • COVID-19-positive (virologically confirmed)
  • All ages and gender
  • Notified to the Federal Capital Territory COVID-19 Control Center based in Gwagwalada
  • Informed consent.
Exclusion criteria
  • Pregnancy
  • History of heart disease
  • Known or reported allergy to any of the trial medications
Interventions
Treatment
HCQ/AZM/Ivermectine
HCQ 200 mg/day orally for three days + Ivermectin 200 mcg/kg/day orally for five days + Azithromycin 500 mg/day orally for three days
Control
Ivermectin
Ivermectin 200 mcg/kg/day orally for five days

Participants
Randomized
participants :
Ivermectin=30
HCQ/AZM/Ivermectine=31
Characteristics of participants
N= 61
Mean age : NR
39 males
Severity : Mild: n=* / Moderate: n=* / Severe: n=20 Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Proportion virologically negative by days 2, 5, 14 and 21 in each arm, other virology outcomes
In the report
Negative PCR outcomes at days 5, 14 and 21
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:

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 IPD file, data from contact with authors and retrospective trial registry were used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plane was available. The primary outcome in the registry is reported in the article. It was unclear how many participants were randomized, consequently, the study was assessed as high risk of bias.
This study was updated on April 14th, 2022 after contact with the authors.