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

Babalola, O E; Ndanusa, YA; Aa, Ajayi; Ogedengbe, JO; Thairu, Y; Omede, O

doi:10.23937/2474-3658/1510233

Cited by 9 publications

(9 citation statements)

References 23 publications

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“…In a third study, Babalola et al, 2021, for 19 severe COVID-19 patients in Nigeria, SpO2 values increased significantly one day after the first dose of IVM (p < 0.008, one-tailed paired t-test) [39,44]. SpO2 values increased even more markedly at two days after the first dose of IVM (p < 0.0023, one-tailed paired t-test).…”

Section: Discussionmentioning

confidence: 98%

“…Yet such SpO2 data are rarely obtained, since severe COVID-19 patients would typically receive supplemental oxygen. However, results without supplemental oxygen were provided in one study of COVID-19 patients in Nigeria (Thairu et al, 2022), which tracked SpO2 values prior to standard treatment and for ten days following [38] as compared with results of a prior study in which IVM treatment was provided in a similarly scheduled regimen [39]. The patients in the standard treatment series were given varying combinations of lopinavir/ritonavir (Alluvia), remdesivir, azithromycin, and enoxaparin (low-molecular-weight heparin, administered to all patients), along with zinc sulfate and vitamin C. The standard treatment regimen used by Thairu et al, 2022, was aggressive; some studies using just heparin as a mainstay of COVID-19 treatment reported successful results [40][41][42].…”

Section: Discussionmentioning

confidence: 99%

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Changes in SpO2 on Room Air for 34 Severe COVID-19 Patients after Ivermectin-Based Combination Treatment: 62% Normalization within 24 Hours

Stone¹,

Ndarukwa

Scheim³

et al. 2022

Biologics

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The emergence of COVID-19 in March 2020 challenged Zimbabwe to respond with limited medical facilities and therapeutic options. Based on early clinical indications of efficacy for the macrocyclic lactone, Ivermectin (IVM), against COVID-19, IVM-based combination treatments were deployed to treat it. Oxygen saturation (SpO2) data were retrospectively analyzed for 34 severe, hypoxic COVID-19 patients all on room air (without supplemental oxygen). The patients, median age 56.5, were treated at clinics or at home between August 2020 and May 2021. All but three of these 34 patients had significantly increased SpO2 values within 24 h after the first IVM dose. The mean increase in SpO2 as a percentage of full normalization to SpO2 = 97 was 55.1% at +12 h and 62.3% at +24 h after the first IVM dose (paired t-test, p < 0.0000001). These results parallel similar sharp, rapid increases in SpO2, all on room air, for 24 mostly severe COVID-19 patients in the USA (California) who were given an IVM-based combination treatment. All patients in both of these critical series recovered. These rapid increases in SpO2 values after IVM treatment stand in sharp contrast to declines in SpO2 and associated pulmonary function through the second week following the onset of moderate or severe COVID-19 symptoms under standard care.

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Section: Discussionmentioning

confidence: 98%

Section: Discussionmentioning

confidence: 99%

Changes in SpO2 on Room Air for 34 Severe COVID-19 Patients after Ivermectin-Based Combination Treatment: 62% Normalization within 24 Hours

Stone¹,

Ndarukwa

Scheim³

et al. 2022

Biologics

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“…The y-axis value at day n is the mean of changes in SpO2 values from day 0 to day n, with error bars designating 95% confidence intervals. ● Thairu et al, 2022 [ 83 , 84 ]: 26 patients, median age 45, treated with varying combinations of lopinavir/ritonavir (Alluvia), remdesivir, azithromycin, and enoxaparin as well as zinc sulfate and vitamin C. ● Babalola et al, 2021 [ 84 , 85 ]: 19 patients, median age 33, treated with IVM, zinc and vitamin C, with some also given azithromycin and hydroxychloroquine. ● Hazan et al, 2021 [ 86 ]: 19 patients, median age 63, treated with IVM, doxycycline and zinc.…”

Section: Discussionmentioning

confidence: 99%

SARS-CoV-2 Spike Protein Induces Hemagglutination: Implications for COVID-19 Morbidities and Therapeutics and for Vaccine Adverse Effects

Boschi

Scheim²,

Bancod

et al. 2022

IJMS

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Experimental findings for SARS-CoV-2 related to the glycan biochemistry of coronaviruses indicate that attachments from spike protein to glycoconjugates on the surfaces of red blood cells (RBCs), other blood cells and endothelial cells are key to the infectivity and morbidity of COVID-19. To provide further insight into these glycan attachments and their potential clinical relevance, the classic hemagglutination (HA) assay was applied using spike protein from the Wuhan, Alpha, Delta and Omicron B.1.1.529 lineages of SARS-CoV-2 mixed with human RBCs. The electrostatic potential of the central region of spike protein from these four lineages was studied through molecular modeling simulations. Inhibition of spike protein-induced HA was tested using the macrocyclic lactone ivermectin (IVM), which is indicated to bind strongly to SARS-CoV-2 spike protein glycan sites. The results of these experiments were, first, that spike protein from these four lineages of SARS-CoV-2 induced HA. Omicron induced HA at a significantly lower threshold concentration of spike protein than the three prior lineages and was much more electropositive on its central spike protein region. IVM blocked HA when added to RBCs prior to spike protein and reversed HA when added afterward. These results validate and extend prior findings on the role of glycan bindings of viral spike protein in COVID-19. They furthermore suggest therapeutic options using competitive glycan-binding agents such as IVM and may help elucidate rare serious adverse effects (AEs) associated with COVID-19 mRNA vaccines, which use spike protein as the generated antigen.

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“…The Alluvia effect appears to be very weak in our hands. This is buttressed by the nding of Babalola et al 7 that, when compared to IVM, Alluvia is much less effective in viral clearance. Unexpectedly, vaccination status appears to have a negative effect on early viral clearance in this study.…”

Section: Ivm Acts On the Jak-stat Pathway Pai-1 And Covid-19 Sequalaementioning

confidence: 99%

“…The preponderance of evidence, based on various meta-analyses, suggests that the drug is e cacious as prophylaxis and as therapy for COVID-19 19 4,5,6 . In Nigeria, Babalola et al 7 demonstrated the superiority of ivermectin (IVM) in viral clearance over alluvia (lopinavir/ritonavir) with a hazard ratio of 2.0 on Cox regression analysis. In addition, Babalola et al 8 compared IVM used alone with the triple therapy of IVM+ hydroxychloroquine (HCQ)+azithromycin (AZM) in Abuja.…”

Section: Introductionmentioning

confidence: 99%

A comparison of Ivermectin and Non Ivermectin based regimen for covid 19 in Abuja: effects on virus clearance, Days-to-Discharge and Mortality.

Yunusa

Babalola

Adesuyi³

et al. 2022

Preprint

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Aim: To compare outcomes from ivermectin (IVM)- and non-ivermectin (NIVM)-based treatments for COVID-19 in Abuja, Nigeria.Methods: Sixty-one consecutive virology-proven cases were recruited and managed with IVM-based regimes. A subsequent cohort of 26 patients was treated with NIVM due to physician preference, with varying combinations of lopinavir/ritonavir (Alluvia), remdesivir, azithromycin, and enoxapramin. All patients received zinc sulfate, vitamin C and supportive therapy. Propensity matching was carried out as indicated, and Repeat Measures Analysis of Variance (RMANOVA) allowing for time*treatment interaction was carried out for time dependent variables, deriving Likelihood Ratio (LR) and P values.Main outcome measures: Change in cycle threshold (viral load) over time, positivity status by day 5, improvement in clinical status using myalgia scores, days to discharge (DTD), change in SpO2 and death. Results: IVM was associated with a greater and faster reduction in viral clearance (LR=64.2 p= 0.000 for the N gene): 31% and 95% were negative by days 5 and 14, respectively, versus 0% on NIVM. The mean DTD on IVM was 8.8 days versus 19.4 days, p= 0.000. IVM proved significantly superior for Myalgia scores, LR= 23.45, P=0.0007. The mortality rate was 0/61 (0%) in IVM but 4/26 (15.3%) in NIVM. Three of the 4 deaths were in females, and 2 had been vaccinated, one fully. The SP02% increased significantly more on IVM (p < 0.0001 RMANOVA) than the NIVM group. C-reactive protein and D-dimer levels dropped significantly more sharply during IVM (P= 0.0068, 0.063), suggesting anti-inflammatory and antifibrinolytic activity.Conclusions: The IVM-based regimen caused earlier discharge from treatment and reduced mortality, in addition to clinical and laboratory improvements. Vaccination did not protect some patients from SARS-CoV-2 breakthrough infection and mortality.

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

Cited by 9 publications

References 23 publications

Changes in SpO2 on Room Air for 34 Severe COVID-19 Patients after Ivermectin-Based Combination Treatment: 62% Normalization within 24 Hours

Changes in SpO2 on Room Air for 34 Severe COVID-19 Patients after Ivermectin-Based Combination Treatment: 62% Normalization within 24 Hours

SARS-CoV-2 Spike Protein Induces Hemagglutination: Implications for COVID-19 Morbidities and Therapeutics and for Vaccine Adverse Effects

A comparison of Ivermectin and Non Ivermectin based regimen for covid 19 in Abuja: effects on virus clearance, Days-to-Discharge and Mortality.

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