Prospective prophylaxis study with 3,532 healthcare workers, 2,199 receiving two-dose ivermectin prophylaxis, showing adjusted relative risk of confirmed COVID-19 with treatment 0.17 [0.12-0.23]
p<0.001. 186 patients took only the first dose, and no significant difference was observed for this group. The same group published an earlier small study with 117 ivermectin patients. There were no serious adverse events. T/IM-NF/CM&FM/20/142.
This is the
38th of 99 COVID-19 controlled studies for ivermectin, which collectively show efficacy with
p<0.0000000001 (1 in 2 sextillion).
46 studies are RCTs, which show efficacy with
p=0.00000014.
risk of case, 83.0% lower, RR 0.17, p < 0.001, treatment 45 of 2,199 (2.0%), control 133 of 1,147 (11.6%), NNT 10, two doses, primary outcome.
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risk of case, 4.0% higher, RR 1.04, p = 0.85, treatment 23 of 186 (12.4%), control 133 of 1,147 (11.6%), patients only receiving the first dose.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Behera et al., 15 Feb 2021, prospective, India, peer-reviewed, 14 authors, dosage 300μg/kg days 1, 4.
Prophylactic Role of Ivermectin in Severe Acute Respiratory Syndrome Coronavirus 2 Infection Among Healthcare Workers
Priyamadhaba Behera, Binod K Patro, Biswa M Padhy, Prasanta R Mohapatra, Shakti K Bal, Pradnya D Chandanshive, Rashmi R Mohanty, S R Ravikumar, Arvind Singh, Sudipta R Singh, Siva Santosh Kumar Pentapati, Jyolsna Nair, Gitanjali Batmanbane
Cureus, doi:10.7759/cureus.16897
Introduction Healthcare workers (HCWs) are vulnerable to getting infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Preventing HCWs from getting infected is a priority to maintain healthcare services. The therapeutic and preventive role of ivermectin in coronavirus disease 2019 (COVID-19) is being investigated. Based on promising results of in vitro studies of oral ivermectin, this study was conducted with the aim to demonstrate the prophylactic role of oral ivermectin in preventing SARS-CoV-2 infection among HCWs at the All India Institute of Medical Sciences (AIIMS) Bhubaneswar.
Methods A prospective cohort study was conducted at AIIMS Bhubaneswar, which has been providing both COVID and non-COVID care since March 2020. All employees and students of the institute who provided written informed consent participated in the study. The uptake of two doses of oral ivermectin (300 μg/kg/dose at a gap of 72 hours) was considered as exposure. The primary outcome of the study was COVID-19 infection in the following month of ivermectin consumption, diagnosed as per Government of India testing criteria (realtime reverse transcriptase polymerase chain reaction [RT-PCR]) guidelines. The log-binomial model was used to estimate adjusted relative risk (ARR), and the Kaplan-Meier failure plot was used to estimate the probability of COVID-19 infection with follow-up time.
Results Of 3892 employees, 3532 (90.8%) participated in the study. The ivermectin uptake was 62.5% and 5.3% for two doses and single dose, respectively. Participants who took ivermectin prophylaxis had a lower risk of getting symptoms suggestive of SARS-CoV-2 infection (6% vs 15%). HCWs who had taken two doses of oral ivermectin had a significantly lower risk of contracting COVID-19 infection during the following month (ARR 0.17; 95% CI, 0.12-0.23). Females had a lower risk of contracting COVID-19 than males (ARR 0.70; 95% CI, 0.52-0.93). The absolute risk reduction of SARS-CoV-2 infection was 9.7%. Only 1.8% of the participants reported adverse events, which were mild and self-limiting.
Conclusion Two doses of oral ivermectin (300 μg/kg/dose given 72 hours apart) as chemoprophylaxis among HCWs reduced the risk of COVID-19 infection by 83% in the following month. Safe, effective, and low-cost chemoprophylaxis has relevance in the containment of pandemic alongside vaccine.
Additional Information Disclosures Human subjects: Consent was obtained or waived by all participants in this study. Institutional Ethics Committee of AIIMS Bhubaneswar issued approval T/IM-NF/CM&FM/20/142. The study was conducted according to the guidelines of the Declaration of Helsinki, and approved by the Institutional Ethics Committee of AIIMS Bhubaneswar. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work.
References