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A recent study in Nigeria shows that using Ivermectin-only (IVM) to treat COVID-19 patients is equally as effective as using the HIA triple therapy (Hydroxychloroquine, Ivermectin, and Azithromycin Combination) in all inflammatory, virological, and respiratory endpoints.
This study was set up to compare Ivermectin with Ivermectin plus HCQ+IVM (HIA).
The study design was a single-blind, randomized, parallel-group study of 2 groups of COVID-19-positive Nigerian patients with 30/31 subjects in each treatment arm.
Thirty patients received ivermectin 200 mcg/kg daily for five days and thirty-one patients received HIA triple therapy. What referred to us HIA triple therapy is the use of Hydroxychloroquine 200mg per day for three days, Ivermectin 200mcg/kg daily for five days, Azithromycin 500mg per day for three days. None of the patients had been vaccinated.
This was a relatively small sample size but it found that both therapies showed significant reductions in inflammation.
Here’s an excerpt from the study:
The ecacy of ivermectin (IVM) against SARS-CoV-2 has been demonstrated in vitro, while several clinical studies suggest that it is ecacious and safe in reducing morbidity and mortality. Hydroxychloroquine HCQ, IVM and azithromycin AZM (HIA therapy) are being used in several low- and middle-income countries (LMICs) where more expensive medications such as remdesivir are out of reach. In this study, we set out to compare the ecacy 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 patients received ivermectin 200 mcg/kg daily for ve days, while 31 patients received HIA triple therapy. The viral cycle threshold (Ct) at pretreatment baseline and days 2, 5 14 and 21 were measured for the E- and N-genes. SPO2 was assessed on a daily basis, while inammatory markers erythrocyte sedimentation rate (ESR), C-reactive protein, and D-dimer and neutrophil/lymphocyte ratios (NLRs) were assessed at baseline and day 7. Clinical status was self-assessed daily on a Likert scale.
Results: Two-way repeated measures analysis of variance (RAMOVA) did not show any difference between the two groups. However, there was a signicant time effect (improvement over time) for SPO2, Ct N-gene, Ct E-gene and clinical status in both groups and signicant reductions in inammatory markers by day 7. (P<0.0001).
Conclusions: AZT + HCQ may be a redundant adjuvant in COVID-19 therapy. Improvements noted are likely due in large part to ivermectin virucidal and anti-inammatory actions.
DISCUSSION:
The clinical, virological, inflammatory, and respiratory (SPO2%) comparative assessments, which are hard end points of our randomized controlled study, did not show a significant difference between IVM monotherapy and HIA triple therapy in RT-PCR-positive COVID-19 patients. This finding indicates that a combination of AZT + HCQ did not confer any additive benefit to IVM in virucidal action against SARS-Cov-2. The results, however, confirm and extend our earlier results on the anti-SARS-CoV-2 efficacy of ivermectin alone4.
In this study, we demonstrate further that ivermectin alone or with HIA rapidly increased the cycle time (Ct) of the N-gene (nucleocapsid) and the E-gene (envelope) of SARS-CoV-2 and achieved significant COVID negativity on day 7 on RAMOVA (see Figures 3 and 4).
IVM and HIA were both associated with significantly reduced pro-inflammatory markers CRP, ESR and D-dimer (Figures 6–8), indicative of antithrombotic and cytokine reduction effects of ivermectin via STAT-3 inhibition, as we have previously suggested4.
Possible side effects of ivermectin: As noted above, there was an overall decrease in the number of complaints by day 5. This suggests that the dose of ivermectin used in this study is safe and efficacious.
In conclusion, there was no significant treatment difference between IVM monotherapy and HIA triple therapy, thus suggesting that AZT + HCQ may be a redundant adjuvant in COVID-19 therapy in Nigerians and elsewhere. There was a highly significant time effect (P< 0.0001 RAMOVA), indicating that the improvements in SARS-CoV-2 N and E-gene Ct, as well as the SPO2%, are likely due in large part to ivermectin virucidal and anti-inflammatory actions.
Hypothesis:
Null hypothesis (H0): A combination of ivermectin and HCQ+A is not more ecacious in the treatment of patients with virology-proven COVID-19 disease than ivermectin alone.
Alternative Hypothesis (Ha): A combination of ivermectin and HCQ is more ecacious in the treatment of patients with virology-proven COVID-19 disease.
You can read the full study here:
A Randomized Controlled Trial of Ivermectin Monotherapy Versus Hydroxychloroquine, Ivermectin, and Azithrom… by Jim Hoft on Scribd
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