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0 0.5 1 1.5 2+ Hospitalization 70% Improvement Relative Risk Viral clearance, MV, day 8 62% Viral clearance, MV, day 6 39% primary Viral clearance, culture 73% Viral clearance, day 10 70% Viral clearance, day 8 82% Viral clearance, day 6 76% Viral clearance, day 4 65% Viral clearance, day 10 (b) 52% Viral clearance, day 8 (b) 58% Viral clearance, day 6 (b) 45% Viral clearance, day 4 (b) 32% c19ivm.org Biber et al. NCT04429711 Ivermectin RCT EARLY TREATMENT Is early treatment with ivermectin beneficial for COVID-19? Double-blind RCT 89 patients in Israel Improved viral clearance with ivermectin (p=0.024) Biber et al., Int. J. Infectious Diseases, doi:10.1016/j.ijid.2022.07.003 Favors ivermectin Favors control
The effect of ivermectin on the viral load and culture viability in early treatment of non-hospitalized patients with mild COVID-19 – A double-blind, randomized placebo-controlled trial
Biber et al., International Journal of Infectious Diseases, doi:10.1016/j.ijid.2022.07.003 (results 2/12/21), NCT04429711 (history)
Biber et al., The effect of ivermectin on the viral load and culture viability in early treatment of non-hospitalized.., International Journal of Infectious Diseases, doi:10.1016/j.ijid.2022.07.003 (results 2/12/21), NCT04429711
Feb 2021   Source   PDF  
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Double blind RCT for mild-moderate COVID-19 outpatients in Israel showing significantly faster reduction in viral load with treatment, and lower hospitalization with treatment. The one treatment hospitalization was a few hours after treatment and the patient improved and was discharged quickly. Authors also examine culture viability on days 2-6, with 13% positive in the ivermectin group vs. 48% in the control group. There were no safety issues. Ivermectin was taken one hour before a meal. Sheba IRB-7156/20. NCT04429711 (history).
risk of hospitalization, 70.2% lower, RR 0.30, p = 0.34, treatment 1 of 47 (2.1%), control 3 of 42 (7.1%), NNT 20.
risk of no viral clearance, 61.6% lower, RR 0.38, p = 0.02, treatment 8 of 47 (17.0%), control 17 of 42 (40.5%), NNT 4.3, adjusted per study, inverted to make RR<1 favor treatment, odds ratio converted to relative risk, Ct>30, multivariable, day 8.
risk of no viral clearance, 39.0% lower, RR 0.61, p = 0.09, treatment 13 of 47 (27.7%), control 21 of 42 (50.0%), NNT 4.5, adjusted per study, inverted to make RR<1 favor treatment, odds ratio converted to relative risk, Ct>30, multivariable, day 6, primary outcome.
risk of no viral clearance, 73.0% lower, RR 0.27, p = 0.008, treatment 3 of 23 (13.0%), control 14 of 29 (48.3%), NNT 2.8, culture viability.
risk of no viral clearance, 70.2% lower, RR 0.30, p = 0.14, treatment 2 of 47 (4.3%), control 6 of 42 (14.3%), NNT 10.0, non-infectious samples (Ct>30 or non-viable culture), day 10.
risk of no viral clearance, 82.1% lower, RR 0.18, p = 0.01, treatment 2 of 47 (4.3%), control 10 of 42 (23.8%), NNT 5.1, non-infectious samples (Ct>30 or non-viable culture), day 8.
risk of no viral clearance, 75.6% lower, RR 0.24, p = 0.02, treatment 3 of 47 (6.4%), control 11 of 42 (26.2%), NNT 5.0, non-infectious samples (Ct>30 or non-viable culture), day 6.
risk of no viral clearance, 65.1% lower, RR 0.35, p = 0.05, treatment 4 of 28 (14.3%), control 9 of 22 (40.9%), NNT 3.8, non-infectious samples (Ct>30 or non-viable culture), day 4.
risk of no viral clearance, 51.9% lower, RR 0.48, p = 0.08, treatment 7 of 47 (14.9%), control 13 of 42 (31.0%), NNT 6.2, Ct>30, day 10.
risk of no viral clearance, 57.9% lower, RR 0.42, p = 0.02, treatment 8 of 47 (17.0%), control 17 of 42 (40.5%), NNT 4.3, Ct>30, day 8.
risk of no viral clearance, 44.7% lower, RR 0.55, p = 0.049, treatment 13 of 47 (27.7%), control 21 of 42 (50.0%), NNT 4.5, Ct>30, day 6.
risk of no viral clearance, 31.9% lower, RR 0.68, p = 0.16, treatment 13 of 28 (46.4%), control 15 of 22 (68.2%), NNT 4.6, Ct>30, day 4.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Biber et al., 12 Feb 2021, Double Blind Randomized Controlled Trial, placebo-controlled, Israel, peer-reviewed, 10 authors, average treatment delay 4.0 days, dosage 12mg days 1-3, 15mg for patients ≥70kg, trial NCT04429711 (history).
Contact: elischwa@tauex.tau.ac.il.
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Abstract: Journal Pre-proof The effect of ivermectin on the viral load and culture viability in early treatment of non-hospitalized patients with mild COVID-19 – A double-blind, randomized placebo-controlled trial Asaf Biber , Geva Harmelin , Dana Lev , Li Ram , Amit Shaham , Ital Nemet , Limor Kliker , Oran Erster , Michal Mandelboim , Eli Schwartz PII: DOI: Reference: S1201-9712(22)00399-X https://doi.org/10.1016/j.ijid.2022.07.003 IJID 6299 To appear in: International Journal of Infectious Diseases Received date: Revised date: Accepted date: 9 May 2022 19 June 2022 2 July 2022 Please cite this article as: Asaf Biber , Geva Harmelin , Dana Lev , Li Ram , Amit Shaham , Ital Nemet , Limor Kliker , Oran Erster , Michal Mandelboim , Eli Schwartz , The effect of ivermectin on the viral load and culture viability in early treatment of non-hospitalized patients with mild COVID19 – A double-blind, randomized placebo-controlled trial, International Journal of Infectious Diseases (2022), doi: https://doi.org/10.1016/j.ijid.2022.07.003 This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2022 Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/) Highlights  Drug-repurposing is a desirable approach to combat a new pathogen.  The value of ivermectin as an anti-SARS-CoV-2 agent is debatable.  Our study shows ivermectin treatment decreased viral-load and culture viability.  These may reflect an anti-SARS-CoV-2 activity of ivermectin.  Further studies are needed to explore its role in combating COVID. 1 The effect of ivermectin on the viral load and culture viability in early treatment of nonhospitalized patients with mild COVID-19 – A double-blind, randomized placebocontrolled trial. Asaf Biber1,2, Geva Harmelin3, Dana Lev1,2, Li Ram3, Amit Shaham3, Ital Nemet4, Limor Kliker4, Oran Erster4, Michal Mandelboim2,4#, Eli Schwartz1,2#. 1. The Center for Geographic Medicine and Tropical Diseases, Sheba Medical Center, Ramat Gan, Israel. 2. Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. 3. Emergency Medicine, Sheba Medical Center, Ramat Gan, Israel. 4. Central Virology Laboratory, Ministry of Health, Ramat Gan, Israel. # These authors equally contributed to the study. Word coumt:3161 Corresponding author: Prof. Eli Schwartz MD, DTMH The Center for Geographic Medicine and Tropical Diseases The Chaim Sheba Medical Center, Tel Hashomer 52621, Israel Tel/Fax:+ 972-3-5308456 Email: elischwa@tauex.tau.ac.il 2 Abstract Objectives- Ivermectin, an anti-parasitic agent, also has anti-viral properties. Our aim was to assess whether ivermectin has anti-SARS-CoV-2 activity. Methods-The double-blinded trial compared patients receiving ivermectin for three days vs. placebo in non-hospitalized adult COVID-19 patients. RT-PCR from a nasopharyngeal-swab was obtained at..
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