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0 0.5 1 1.5 2+ Symptomatic case 91% primary Improvement Relative Risk Severe case 93% Shouman et al. NCT04422561 Ivermectin RCT Prophylaxis Is prophylaxis with ivermectin beneficial for COVID-19? RCT 304 patients in Egypt Fewer symptomatic cases (p=0.001) and lower severe cases (p=0.0022) Shouman et al., J. Clinical and Diagnostic Resea.., doi:10.7860/JCDR/2020/46795.0000 Favors ivermectin Favors control
Use of Ivermectin as a Potential Chemoprophylaxis for COVID-19 in Egypt: A Randomised Clinical Trial
Shouman et al., Journal of Clinical and Diagnostic Research, doi:10.7860/JCDR/2020/46795.0000, NCT04422561 (history)
Shouman et al., Use of Ivermectin as a Potential Chemoprophylaxis for COVID-19 in Egypt: A Randomised Clinical Trial, Journal of Clinical and Diagnostic Research, doi:10.7860/JCDR/2020/46795.0000, NCT04422561
Aug 2020   Source   PDF  
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PEP trial for asymptomatic close contacts of COVID-19 patients, 203 ivermectin patients and 101 control patients. 7.4% of contacts developed COVID-19 in the ivermectin group vs. 58.4% in the control group. Efficacy for symptomatic cases and severe cases is very similar. Adjusted results are provided only for symptomatic cases. See also [].
risk of symptomatic case, 91.3% lower, RR 0.09, p < 0.001, treatment 15 of 203 (7.4%), control 59 of 101 (58.4%), NNT 2.0, adjusted per study, inverted to make RR<1 favor treatment, multivariate, primary outcome.
risk of severe case, 92.9% lower, RR 0.07, p = 0.002, treatment 1 of 203 (0.5%), control 7 of 101 (6.9%), NNT 16, unadjusted.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Shouman et al., 28 Aug 2020, Randomized Controlled Trial, Egypt, peer-reviewed, 8 authors, dosage 18mg days 1, 3, dose varies depending on weight - 40-60kg: 15mg, 60-80kg: 18mg, >80kg: 24mg, trial NCT04422561 (history).
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Abstract: Internal Medicine Section DOI: 10.7860/JCDR/2021/46795.14529 Original Article Use of Ivermectin as a Potential Chemoprophylaxis for COVID-19 in Egypt: A Randomised Clinical Trial Waheed M Shouman1, Abdelmonem Awad Hegazy2, Ramadan M Nafae3, Moustafa I Ragab4, Saad R Samra5, Dalia Anas Ibrahim6, Tarek H AL-Mahrouky7, Ashraf E Sileem8 ABSTRACT Introduction: The rate of secondary attacks of SARS-COV-2 is high among household close contacts. Social distancing, isolation and infection control measures are important for preventing exposure to infection, but insufficient. Aim: The study aimed to evaluate possible role of oral ivermectin as a chemoprophylaxis in asymptomatic family close contacts with COVID-19 patients. Materials and Methods: A prospective interventional randomised open label-controlled study was conducted (registered at; NCT04422561) during June and July 2020. Two arms were designed according to use of ivermectin. In ivermectin arm, contacts received ivermectin according to Body Weight (BW) on day of the diagnosis of their index case. The non-intervention group received no treatment. Both groups were followed-up for two weeks for development of symptoms suggestive of COVID-19. Results: Ivermectin group included 203 contacts (to 52 index cases) aged 39.75±14.94 years; 52.2% were males. Nonintervention group included 101 contacts (to a total of 24 index cases) aged 37.69±16.96 years, 49.5% were males. Fifteen contacts (7.4%) developed COVID-19 in the ivermectin arm compared to 59 (58.4%) in the non-intervention arm (p<0.001). The protection rate for ivermectin was more prominent in contacts aged less than 60-year-old (6.2% infected compared to 58.7% if no treatment). Ivermectin in the protection against SARS-CoV-2 infection had an OR of 12.533 and 11.445 (compared to nontreatment) in both univariate and multivariate models, respectively. Side effects of ivermectin were reported in 5.4%; they were mild. Conclusion: Ivermectin is suggested to be a promising, effective and safe chemoprophylactic drug in management of COVID-19. Keywords: Close contacts, Control, Coronavirus, Pandemic, SARS-CoV-2
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