Use of Ivermectin as a Potential Chemoprophylaxis for COVID-19 in Egypt: A Randomised Clinical Trial
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
[trialsitenews.com].
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.
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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.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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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).
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 clinicaltrials.gov; 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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