A Randomized Controlled Trial of Ivermectin Monotherapy Versus Hydroxychloroquine, Ivermectin, and Azithromycin Combination Therapy in Covid-19 Patients in Nigeria
Small RCT with 61 patients in Nigeria, all patients treated with ivermectin, zinc, and vitamin C, showing no significant improvements in recovery with the addition of HCQ+AZ.
risk of no hospital discharge, 54.5% higher, RR 1.55, p = 0.20, treatment 17 of 30 (56.7%), control 11 of 30 (36.7%), day 7.
risk of no viral clearance, 9.5% lower, RR 0.90, p = 0.78, treatment 19 of 30 (63.3%), control 21 of 30 (70.0%), NNT 15, day 5 mid-recovery.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Babalola et al., 1 Oct 2021, Single Blind Randomized Controlled Trial, Nigeria, peer-reviewed, 6 authors, this trial uses multiple treatments in the treatment arm (combined with AZ) - results of individual treatments may vary, trial PACTR202108891693522
Babalola et al. J Infect Dis Epidemiol 2021, 7:233
Volume 7 | Issue 10
Infectious Diseases and Epidemiology
Randomised Drug Trial
A Randomized Controlled Trial of Ivermectin Monotherapy
versus Hydroxychloroquine, Ivermectin, and Azithromycin
Combination Therapy in COVID- 19 Patients in Nigeria
Babalola OE1*, Ndanusa YA2, Ajayi AA3, Ogedengbe JO4, Thairu Y4 and Omede O5
Bingham University, Karu, Nigeria
Al Ummah Foundation, Abuja, Nigeria
Baylor College of Medicine, Texas, USA
University of Abuja, Nigeria
Federal Ministry of Health, Abuja, Nigeria
*Corresponding author: Olufemi Emmanuel Babalola, Bingham University, Karu, Nigeria
The efficacy of Ivermectin (IVM) against SARS-CoV-2 has
been demonstrated in vitro, while several clinical studies
suggest that it is efficacious and safe in reducing morbidity
and mortality. Hydroxychloroquine (HCQ, Quinoric®), IVM
and Azithromycin(AZM, Zithromax®) (HIA therapy) is being
used in several low- and middle-income countries (LMIC)
where more expensive medications such as Remdesivir are
out of reach. In this study, we set out to compare the efficacy
of IVM monotherapy with HIA combination therapy.
Methods: This was a single-blind, randomized control trial,
of 2 parallel groups of COVID-19 Positive Nigerians. Thirty
(30) patients received Ivermectin (Mectizan®) 200 mcg/
kg daily for five days, while 31 patients received HIA triple
therapy. Viral cycle threshold (Ct) at pre-treatment baseline,
and days 2, 5, 14 and 21 were measured for E- and
N-genes (Envelope and Nucleocapsid genes respectively).
SpO2 (percentage saturation of oxygen in the blood) was
assessed on a daily basis, while inflammatory markers
such as Erythrocyte Sedimentation Rate (ESR), C-Reactive
Protein, and D-dimer and Neutrophil/Lymphocyte Ratios
(NLR), were assessed at baseline and day 7 post treatment.
Clinical status was self-assessed daily on a Likert scale.
Results: 2-way Repeated measures Analysis of Variance
(RMANOVA) did not show any difference between the
two groups. However, there was a significant time effect
(improvement over time) for SpO2, Ct N-gene, Ct E-gene
and clinical status in both groups, and significant reductions
in inflammatory markers by day 7 (P < 0.0001).
Conclusions: AZT + HCQ may be redundant adjuncts
in COVID-19 therapy. Improvements noted are likely due
in large part to Ivermectin virucidal and anti-inflammatory
is less effective
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