Efficacy and safety of ivermectin in the treatment of mild-to-moderate COVID-19 infection: A randomized, double blind, placebo, controlled trial
Manomaipiboon et al.,
Efficacy and safety of ivermectin in the treatment of mild-to-moderate COVID-19 infection: A randomized,..,
Trials, doi:10.1186/s13063-022-06649-3 (date from earlier preprint), NCT05076253
Small RCT with 72 low-risk patients in Thailand, showing improved recovery with ivermectin, without statistical significance. All patients recovered and there was no escalation of care in either group. There were no adverse events.
risk of no recovery, 43.5% lower, RR 0.57, p = 0.26, treatment 3 of 36 (8.3%), control 6 of 36 (16.7%), NNT 12, adjusted per study, odds ratio converted to relative risk, resolution of symptoms, Table S2, day 28.
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recovery time, 15.3% lower, RR 0.85, p = 0.56, treatment 36, control 36, inverted to make RR<1 favor treatment, time to resolution of symptoms.
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risk of no viral clearance, 5.0% lower, RR 0.95, p = 1.00, treatment 19 of 36 (52.8%), control 20 of 36 (55.6%), NNT 36, day 14, primary outcome.
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risk of no viral clearance, 3.3% lower, RR 0.97, p = 1.00, treatment 29 of 36 (80.6%), control 30 of 36 (83.3%), NNT 36, day 7.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Manomaipiboon et al., 2 Feb 2022, Double Blind Randomized Controlled Trial, placebo-controlled, Thailand, peer-reviewed, mean age 48.6, 8 authors, study period 10 October, 2021 - 15 December, 2021, dosage 12mg days 1-5, trial
NCT05076253 (history).
Contact:
thananda@hotmail.com (corresponding author).
Abstract: Efficacy and safety of ivermectin in the treatment of
mild-to-moderate COVID-19 infection: A randomized,
double blind, placebo, controlled trial
Anan Manomaipiboon
Navamindradhiraj University
Kitisak Pholtawornkulchai
Navamindradhiraj University
Sujaree Pupipatpab
Navamindradhiraj University
Swangjit Suraamornkul
Navamindradhiraj University
Jakravoot Maneerit
Navamindradhiraj University
Wiroj Ruksakul
Navamindradhiraj University
Uraporn Phumisantiphong
Navamindradhiraj University
Thananda Trakarnvanich ( thananda@hotmail.com )
Navamindradhiraj University
Research Article
Keywords: Efficacy, Ivermectin, COVID-19, Randomized-controlled trial, SARS-CoV-2, RT-PCR
Posted Date: February 2nd, 2022
DOI: https://doi.org/10.21203/rs.3.rs-1290999/v1
License: This work is licensed under a Creative Commons Attribution 4.0 International License.
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Abstract
The emergent outbreak of coronavirus disease (COVID-19), caused by severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2), has emphasized the requirement for therapeutic opportunities to overcome
this pandemic. Ivermectin is an antiparasitic drug that has shown to be effective against various agents,
including SARS-CoV-2, and is under extensive research in clinical trials. In this randomized, double-blind,
placebo-controlled trial among adult hospitalized patients with mild-to-moderate COVID-19, 72 patients
(mean age 48.57 ± 14.80 years) were randomly assigned to either the ivermectin (n=36) or placebo
(n=36) group, along with receiving standard care. The primary outcomes were a negative reverse
transcription polymerase chain reaction (RT-PCR) result at day 7 and 14 of enrolment. The secondary
outcomes were duration of hospitalization, frequency of clinical worsening, survival on day 28, and
adverse events. At day 7 and 14, a negative RT-PCR result was not significantly different between the two
groups. The other secondary outcomes were reported to be comparable. However, the time to resolution
of many symptoms were shorter in the ivermectin group, albeit not significantly. No adverse events were
reported. In conclusion, early symptomatic recovery was observed with no side effects after treatment
with ivermectin and standard care in mild-to-moderate COVID-19 patients.
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