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A Randomized Controlled Trial of Ivermectin Monotherapy versus Hydroxychloroquine, Ivermectin, and Azithromycin Combination Therapy in COVID-19 Patients in Nigeria

Babalola et al., Journal of Infectious Diseases and Epidemiology, doi:10.23937/2474-3658/1510233 (date from preprint), PACTR202108891693522
Oct 2021  
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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.
This study includes ivermectin and HCQ.
Babalola et al., 1 Oct 2021, Single Blind Randomized Controlled Trial, Nigeria, peer-reviewed, 6 authors, trial PACTR202108891693522.
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A Randomized Controlled Trial of Ivermectin Monotherapy versus Hydroxychloroquine, Ivermectin, and Azithromycin Combination Therapy in COVID- 19 Patients in Nigeria
O E Babalola, Y A Ndanusa, A A Ajayi, J O Ogedengbe, Y Thairu, O Omede
Journal of Infectious Diseases and Epidemiology, doi:10.23937/2474-3658/1510233
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 actions. RANdOmisEd dRug TRiAl
Trial ID PACTR202108891693522.
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