Trial ISRCTN40302986
Publication Babalola OE, IVERCOVID, QJM, 2021 (published paper)
Dates: 6/22/2020 to 9/22/2020
Funding: Private (Rachel Eye Center, Abuja; Crystal Optics (Nig) Ltd.)
Conflict of interest: no COI

Methods
RCT
Blinding: double blinding
Location : Single center / Nigeria
Follow-up duration (days): 14
Inclusion criteriaCOVID 19 PCR proven positive patients, who gave informed, written consent to participate in the study, and were either asymptomatic or had mild/moderate symptoms
Exclusion criteriaCOVID 19 negative patients, patients who had COVID pneumonia or requiring ventilator therapy, renal failure, thromboembolic complications, or unconscious by reduced Glasgow Coma Scale
Interventions
Treatment 1
Ivermectin 6mg (6 mg)
Co-Intervention: Standard care
Duration : 14 days
Control
Ivermectin 12mg (12 mg)
Co-Intervention: Standard care
Duration : 14 days
Control
Lopinavir-Ritonavir
Participants
Randomized
62 participants n1=21/ n2=21/ n3=20
Characteristics of participants
N=62
Mean age : 44.3
43 males
Severity : Mild: n=57 / Moderate: n=3/ Severe: n=0 Critical: n=0
Primary outcome
In the register
Viral RNA load measured using quantitative branched DNA (bDNA), reverse transcriptase-polymerase chain reaction (RT-PCR), and qualitative transcription-mediated amplification at baseline and 1, 2, 4, 7, 10, 12, 14 days
In the report
NR
Documents
available

Protocol

Yes. In English

Statistical plan

NR

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 pre-print article, the trial registry and protocol were used in data extraction and risk of bias assessment. The proof of concept study achieved its pre-stated sample size. There is conflicting information between the report and its protocol. In the report, no placebo is described beyond the brief mention in the abstract. According to the report, patients in the control arm received Lopinavir/Ritonavir, which was not allowed for patients in the Ivermectin arms. In the protocol and registry, patients in the control arm were to receive an inactive placebo. The protocol also describes the administration of lopinavir/ritonavir to those in the control arm. As a result of lopinavir/ritonavir not being allowed for patients in the ivermectin arms, this treatment difference not only plausibly affected outcomes, but also compromised the blinding of physicians and study personnel. Furthermore, the number of tablets given to the patients would also likely reveal the treatment assignment to patients, since 2 tablets were given to those in the 3mg ivermectin group and 4 tablets to those in the 12mg group.
The study was updated on March 23rd, 2021 with data from the QJM, without substantial changes.