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Favorable outcome on viral load and culture viability using Ivermectin in early treatment of non-hospitalized patients with mild COVID-19, A double-blind, randomized placebo-controlled trial.
Asaf Biber; Michal Mandelboim; Geva Harmelin; Dana Lev; Li Ram; Amit Shaham; Ital Nemet; Limor Kliker; Oran Erster; Eli Schwartz.
Affiliation
  • Asaf Biber; The Sheba Medical Center
  • Michal Mandelboim; Ministry of Health of Israel
  • Geva Harmelin; Sheba Medical Center
  • Dana Lev; Sheba Medical Center
  • Li Ram; Sheba Medical Center
  • Amit Shaham; Sheba Medical Center
  • Ital Nemet; Ministry of Health of Israel
  • Limor Kliker; Ministry of Health of Israel
  • Oran Erster; Ministry of Health of Israel
  • Eli Schwartz; Sheba Medical Center
Preprint in English | medRxiv | ID: ppmedrxiv-21258081
ABSTRACT
BackgroundIvermectin, an anti-parasitic agent, also has anti-viral properties. Our aim was to assess whether ivermectin can shorten the viral shedding in patients at an early-stage of COVID-19 infection. MethodsThe double-blinded trial compared patients receiving ivermectin 0{middle dot}2 mg/kg for 3 days vs. placebo in non-hospitalized COVID-19 patients. RT-PCR from a nasopharyngeal swab was obtained at recruitment and then every two days. Primary endpoint was reduction of viral-load on the 6th day (third day after termination of treatment) as reflected by Ct level>30 (non-infectious level). The primary outcome was supported by determination of viral culture viability. ResultsEighty-nine patients were eligible (47 in ivermectin and 42 in placebo arm). Their median age was 35 years. Females accounted for 21{middle dot}6%, and 16{middle dot}8% were asymptomatic at recruitment. Median time from symptom onset was 4 days. There were no statistical differences in these parameters between the two groups. On day 6, 34 out of 47 (72%) patients in the ivermectin arm reached the endpoint, compared to 21/ 42 (50%) in the placebo arm (OR 2{middle dot}62; 95% CI 1{middle dot}09-6{middle dot}31). In a multivariable logistic-regression model, the odds of a negative test at day 6 was 2.62 time higher in the ivermectin group (95% CI 1{middle dot}06-6{middle dot}45). Cultures at days 2 to 6 were positive in 3/23 (13{middle dot}0%) of ivermectin samples vs. 14/29 (48{middle dot}2%) in the placebo group (p=0{middle dot}008). ConclusionsThere were significantly lower viral loads and viable cultures in the ivermectin group, which could lead to shortening isolation time in these patients. The study is registered at ClinicalTrials.gov NCT 044297411.
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Full text: Available Collection: Preprints Database: medRxiv Type of study: Experimental_studies / Prognostic study / Rct Language: English Year: 2021 Document type: Preprint
Full text: Available Collection: Preprints Database: medRxiv Type of study: Experimental_studies / Prognostic study / Rct Language: English Year: 2021 Document type: Preprint
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