Effectiveness of ivermectin-based multidrug therapy in severely hypoxic, ambulatory COVID-19 patients

Sabine Hazan, Sonya Dave, Anoja W Gunaratne, Sibasish Dolai, Robert L Clancy, Peter A McCullough, Thomas J Borody, Sabine Hazan, Sonya Dave, Anoja W Gunaratne, Sibasish Dolai, Robert L Clancy, Peter A McCullough, Thomas J Borody

Abstract

Aims: Ivermectin is a safe, inexpensive and effective early COVID-19 treatment validated in 20+ random, controlled trials. Having developed combination therapies for Helicobacter pylori, the authors present a highly effective COVID-19 therapeutic combination, stemming from clinical observations. Patients & methods: In 24 COVID-19 subjects refusing hospitalization with high-risk features, hypoxia and untreated moderate to severe symptoms averaging 9 days, the authors administered this novel combination of ivermectin, doxycycline, zinc and vitamins D and C. Results & conclusions: All subjects resolved symptoms (in 11 days on average), and oxygen saturation improved in 24 h (87.4% to 93.1%; p = 0.001). There were no hospitalizations or deaths, less than (p < 0.002 or 0.05, respectively) background-matched CDC database controls. Triple combination therapy is safe and effective even when used in outpatients with moderate to severe symptoms. Clinical Trial Registration: NCT04482686 (ClinicalTrial.gov).

Keywords: COVID; SARS-CoV-2; coronavirus; doxycycline; ivermectin; zinc.

Conflict of interest statement

Financial & competing interests disclosure

This study was funded by ProgenaBiome, LLC. S Hazan declares that she has pecuniary interest in Topelia Pty Ltd in Australia and Topelia Pty Ltd in the USA where development of COVID-19 preventative/treatment options are being pursued. She has also filed patents relevant to coronavirus treatments. She is the founder and owner of Microbiome Research Foundation, ProgenaBiome and Ventura Clinical Trials. TJ Borody declares that he has pecuniary interest in Topelia Pty Ltd in Australia and Topelia Therapeutics, Inc. in the USA developing COVID-19 preventative/treatment medications. He has also filed patents relevant to COVID-19 treatments. S Dave declares she has corporate affiliation to McKesson Specialty Health / Ontada and North End Advisory, LLC, and affiliation to Microbiome Research Foundation (a non-profit). S Dave is unaware of and not directly involved in COVID-19 treatment–relevant projects at McKesson, but they may exist. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed

S Dave provided medical writing assistance for this paper and was funded by ProgenaBiome and Microbiome Research Foundation.

Figures

Figure 1.. Complete recovery was seen in…
Figure 1.. Complete recovery was seen in all patients within 1 to 3 weeks.
(A) Time in days to various stages of symptom onset and resolution. Nearly all subjects resolved symptoms and became PCR negative in 3 weeks. Col 1: Symptom onset to start of treatment (n = 23; mean: 9.17 ± 2.05). Col 2: Start of treatment to resolution of symptoms (n = 23; mean: 11.61 ± 1.38). Col 3: First PCR positive to first PCR negative (n = 10; mean: 16.90 ± 1.58). Col 4: Start of treatment to first PCR negative (n = 10; mean: 11.50 ± 1.60). (B) Top, 100% survival rate was seen in patients, which is significantly higher (p = 0.044 via Chi-Square, χ2, test) than synthetic control from CDC database of equivalent or less COVID-vulnerable subjects. Bottom, no (0%) patients required hospitalization, which is significantly less (p = 0.0011 via χ2 test) than synthetic control from database.
Figure 2.. All subjects reached successful treatment…
Figure 2.. All subjects reached successful treatment (SpO2 above 95%) and experienced significant increase in SpO2 within 24 h.
(A) O2 saturation prior to treatment was significantly (p < 0.05) less than 95%, the defined successful treatment reached by all subjects. (B) O2 saturation significantly increased in subjects 24 h after treatment (paired t-test, p < 0.001, only subjects with data before and after treatment included). O2 saturation continued to rise until the defined cure of greater than 95% O2 saturation was reached.
Figure 3.. Ambulatory COVID scores, Covidex and…
Figure 3.. Ambulatory COVID scores, Covidex and Covidex-F (see methods for definition; Covidex-F includes fever measure) versus time from start of treatment to symptom resolution.
There was a significant relation between either Covidex score (Covidex: p = 0.0288; Covidex-F: p = 0.0096) and treatment resolution time.

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Source: PubMed

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