Evaluation of Ivermectin as a Potential Treatment for Mild to Moderate COVID-19: A Double-Blind Randomized Placebo Controlled Trial in Eastern India
Ranjini Roy, Chandrima Pattadar, Rishav Raj, Neeraj Agarwal, Dr Bijit Biswas, Pramod Kumar Manjhi, Deependra Kumar Rai, Anjani Kumar, Asim Sarfaraz, Ranjini Ravikirti, Chandrima Roy, Rishav Pattadar, Bijit Raj, Neeraj Biswas, Pramod Kumar Agarwal, Manjhi, Kumar Deependra, Rai, Anjani Shyama, Asim Kumar, Sarfaraz
There has been a growing interest in ivermectin ever since it was reported to have an in-vitro activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This trial was conducted to test the efficacy of ivermectin in mild and moderate coronavirus disease 19 . Methods: A double blind, parallel, randomised, placebo-controlled trial conducted among adult COVID-19 patients with mild to moderate disease severity on admission in a COVID dedicated tertiary healthcare of eastern India. Enrolment was done between 1 st August and 31 st October 2020. On day 1 and 2 post enrolment, patients in the intervention arm received ivermectin 12 mg while the patients in the non-interventional arm received placebo tablets. Results: About one-fourth (23.6%) of the patients in the intervention arm and onethird (31.6%) in the placebo arm were tested reverse transcriptase polymerase chain reaction (RTPCR) negative for SARS-CoV-2 on 6 th day. Although this difference was found to be statistically insignificant [rate ratio (RR): 0.8; 95% confidence interval (CI): 0.4-1.4; p=0.348]. All patients in the ivermectin group were successfully discharged. In comparison the same for the placebo group was observed to be 93%. This difference was found to be statistically significant (RR: 1.1; 95% CI; 1.0-1.2; p=0.045). Conclusions: Inclusion of ivermectin in treatment regimen of mild to moderate COVID-19 patients could not be said with certainty based on our study results as it had shown only marginal benefit in successful discharge from the hospital with no other observed benefits.
References
Abani, Abbas, Abbas, Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial, Lancet Lond Engl,
doi:10.1016/S0140-6736(21)00676-0Agarwal, Mukherjee, Kumar, Convalescent plasma in the management of moderate covid-19 in adults in India: open label phase II multicentre randomised controlled trial (PLACID Trial), BMJ,
doi:10.1136/bmj.m3939Ahmed, Karim, Ross, A five-day course of ivermectin for the treatment of COVID-19 may reduce the duration of illness, Int J Infect Dis IJID Off Publ Int Soc Infect Dis,
doi:10.1016/j.ijid.2020.11.191Alam, Murshed, Bhiuyan, Saber, Alam et al., Observational Study on Clinical Features, Treatment and Outcome of COVID 19 In A Tertiary Care Centre in India-A Retrospective Case Series, J Bangladesh Coll Physicians Surg,
doi:10.3329/jbcps.v38i0.47512Babalola, Bode, Ajayi, Ivermectin shows clinical benefits in mild to moderate COVID19: a randomized controlled double-blind, dose-response study in Lagos, QJM Int J Med. Published online,
doi:10.1093/qjmed/hcab035Cao, Wang, Wen, A Trial of Lopinavir-Ritonavir in Adults Hospitalized with Severe Covid-19, N Engl J Med,
doi:10.1056/NEJMoa2001282Chaccour, Casellas, Blanco-Di Matteo, The effect of early treatment with ivermectin on viral load, symptoms and humoral response in patients with nonsevere COVID-19: A pilot, double-blind, placebo-controlled, randomized clinical trial, EClinicalMedicine,
doi:10.1016/j.eclinm.2020.100720Gonzalez, Gonzalez, Ueno, Ivermectin in Human Medicine, An Overview of the Current Status of Its Clinical Applications, Curr Pharm Biotechnol,
doi:10.2174/138920112800399248Heidary, Gharebaghi, Ivermectin: a systematic review from antiviral effects to COVID-19 complementary regimen, J Antibiot,
doi:10.1038/s41429-020-0336-zInsiat, Rabby, Current Drugs with Potential for Treatment of COVID-19: A Literature Review, J Pharm Pharm Sci,
doi:10.18433/jpps31002Kinobe, Owens, A systematic review of experimental evidence for antiviral effects of ivermectin and an in silico analysis of ivermectin's possible mode of action against SARS-CoV-2, Fundam Clin Pharmacol,
doi:10.1111/fcp.12644López-Medina, López, Hurtado, Effect of Ivermectin on Time to Resolution of Symptoms Among Adults With Mild COVID-19: A Randomized Clinical Trial, JAMA,
doi:10.1001/jama.2021.3071Mahmud, Rahman, Alam, Ivermectin in combination with doxycycline for treating COVID-19 symptoms: a randomized trial, J Int Med Res,
doi:10.1177/03000605211013550Okumuş, Demirtürk, Çetinkaya, Evaluation of the effectiveness and safety of adding ivermectin to treatment in severe COVID-19 patients, BMC Infect Dis,
doi:10.1186/s12879-021-06104-9Padhy, Mohanty, Das, Meher, Therapeutic potential of ivermectin as add on treatment in COVID 19: A systematic review and meta-analysis, J Pharm Pharm Sci,
doi:10.18433/jpps31457Rajter, Sherman, Fatteh, Vogel, Sacks et al., Use of Ivermectin Is Associated With Lower Mortality in Hospitalized Patients With Coronavirus Disease 2019: The Ivermectin in COVID Nineteen Study, Chest,
doi:10.1016/j.chest.2020.10.009Shahbaznejad, Davoudi, Eslami, Effect of ivermectin on COVID-19: A multicenter double-blind randomized controlled clinical trial, Clin Ther. Published online,
doi:10.1016/j.clinthera.2021.04.007Sterne, Murthy, Diaz, Association Between Administration of Systemic Corticosteroids and Mortality Among Critically Ill Patients With COVID-19: A Meta-analysis, JAMA,
doi:10.1001/jama.2020.17023DOI record:
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