Safety and Efficacy of the Combined Use of Ivermectin, Dexamethasone, Enoxaparin and Aspirina against COVID-19 the I.D.E.A. Protocol

Carvallo et al., Journal of Clinical Trials, 11:459 (date from preprint)

Sep 2020

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Prospective trial of ivermectin, dexamethasone, enoxaparin, and aspirin, showing no hospitalization for mild cases, and lower mortality for moderate/severe patients.

This is the 7th of 99 COVID-19 controlled studies for ivermectin, which collectively show efficacy with p<0.0000000001 (1 in 2 sextillion). 46 studies are RCTs, which show efficacy with p=0.00000014.

This study is excluded in the after exclusion results of meta analysis: minimal details of groups provided.

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risk of death, 85.4% lower, RR 0.15, p = 0.08, treatment 1 of 32 (3.1%), control 3 of 14 (21.4%), NNT 5.5, moderate/severe patients, the only treatment death was a patient already in the ICU before treatment, primary outcome.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

Carvallo et al., 15 Sep 2020, prospective, Argentina, peer-reviewed, mean age 55.7, 3 authors, dosage 36mg days 1, 8, dose varied depending on patient condition - mild 24mg, moderate 36mg, severe 48mg, this trial uses multiple treatments in the treatment arm (combined with dexamethasone, enoxaparin, and aspirin) - results of individual treatments may vary.

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Safety and Efficacy of the Combined Use of Ivermectin, Dexamethasone, Enoxaparin and Aspirina against COVID-19 the I.D.E.A. Protocol

Carvallo Hector, Hirsch Roberto

From the first outbreak in Wuhan (China) in December 2019, until today (05/28/2020), the number of deaths worldwide due to the coronavirus pandemic exceeded 2.5 millions. Only in Argentina, 50,000 deaths have been confirmed so far. There haven't been so far any clear diagnostic pattern for this exceptional entity except unilateral skin involvement, early onset of symptoms, positive ANA and negative tests for Borrelia burgdorferi. Hence, we report a new case of a young Moroccan man. No treatment tested worldwide has shown unquestionable efficacy in the fight against COVID-19, according to W.H.O, NIH and NICE reports and accumulated data. Our proposal consists of the combination of drugs, based on the pathophysiology of the virus. We have designed a treatment called I.D.E.A., based on four affordable drugs already available on the pharmacopoeia in Argentina, on the following rationale: -Ivermectin (IVM) solution to lower the viral load in all stages of COVID-19. -Dexamethasone 4 mg injection, as anti-inflammatory drug to treat hyperinflammatory reaction to COVID-infection. -Enoxaparin injection as anticoagulant to treat hypercoagulation in severe cases. -Aspirin 250 mg tablets to prevent hypercoagulation in mild and moderate cases. Except for Ivermection oral solution, which was used in a higher dose than approved for parasitosis, all other drugs were used in the already approved dose and indication. Regarding Ivermectin safety, several oral studies have shown it to be safe even when used at daily doses much higher than those approved already. A clinical study has been conducted on COVID-19 patients at Eurnekian Hospital in the Province of Buenos Aires, Argentina. The study protocol and its final outcomes are described in this article. Results were compared with published data and data from patients admitted to the hospital receiving other treatments. None of the patient presenting mild symptoms needed to be hospitalized. Only one patient died (0.59% of all included patients vs. 2.1% overall mortality for the disease in Argentina today, 3.1% of hospitalized patients vs. 26.8% mortality in published data). I.D.E.A. protocol has proved to be a very effective alternative to prevent disease progression of COVID-19 when applied to mild cases, and to decrease mortality in patients at all stages of the disease with a favorable risk-benefit ratio.

CONFLICT OF INTEREST The Authors manifest no conflict of interests.

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