Ivermectin 6mg vs Ivermectin 12mg (RCT)

Hospitalized patients

FOREST PLOTS -2021-01-21

Studies description

Trial ISRCTN40302986
Publication IVERCOVID - Babalola OE, QJM (2021) (published paper)
Dates: 2020-06-22 to 2020-09-22
Funding: Private (Rachel Eye Center, Abuja; Crystal Optics (Nig) Ltd.)
Conflict of interest: No

Methods
RCT
Blinding: Double blinded, no restrictions
Location : Single center / Nigeria
Follow-up duration (days): 14
Inclusion criteria
  • COVID 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 criteria
  • COVID 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
Ivermectin
6 mg orally twice a week for 2 weeks

Ivermectin 6mg
6 mg orally twice a week for 2 weeks

Ivermectin 12 mg
12 mg orally twice a week for 2 weeks
Control
Lopinavir-ritonavir
Lopinavir/ritonavir daily for 2 weeks

Participants
Randomized
NR

Analyzed
104 participants Ivermectin =42
Ivermectin 6mg=21
Ivermectin 12 mg=21
Lopinavir-ritonavir=20
Characteristics of participants
N= 104
Mean age : NR
58 males
Severity : Mild: n=78 / Moderate: n=5 / 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
avalaible

Protocol

Yes. In English

Statistical plan

NR

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 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.