On Dec 31, 2019, WHO was informed of a cluster of unexplained cases of pneumonia in Wuhan, Hubei province, China (1,2,3,4). The World Health Organization (WHO) has described this disease process, called as COVID-19 (Coronavirus disease-2019).  There is an urgency of developing a therapeutic strategy in order to control the spread of COVID-19(5). Ivermectin is FDA approved drug, known to have wide-spectrum antiviral activity against number of viruses under in vitro conditions (5,6,7,8,9). The drug has an excellent safety profile, and has been used for more than 30 years with an excellent safety profile. More than 2.7 billion doses have been distributed both as individual treatment and as control of neglected tropical diseases (NTDs) at the approved dose of 150–200 μg/kg, yearly, and with no major safety concerns(10,11). This drug has demonstrated in vitro efficacy against COVID 19 and there are clinical trials that have been initiated, to assess the efficacy in COVID 19. The drugs have been approved by LNJP institutional committee for use in all admitted COVID 19 patients, with precautions in specific groups. We are already using the drug, in admitted patients, in department of pediatrics (12). Given the fact that it is an easily and locally available, is a cheap drug, with a well-established safety profile, and has demonstrated in-vitro effects against COVID 19, we chose this drug for its potential against COVID 19.

For the purpose of this study, we intend to do a single centre, randomized controlled, open labelled trial, to assess, the efficacy of single dose ivermectin, given within first 72 hours, of symptom onset, as assessed by Reverse transcription polymerase chain reaction (RT-PCR) for severe acute respiratory syndrome coronavirus 2 (SARS CoV 2), at 3^rd and 7th day of treatment. We also want to assess through the study, the safety profile of the drug, symptom resolution as assessed everyday till 7 days of admission. At Day 21, from the administration of drug. we intend to have a telephonic conversation to assess any residual symptoms. For the purpose of the study, we shall include patients, who satisfy the inclusion and exclusion criterion as detailed further in this document, then randomize them into either ivermectin or control group, before administering single dose of ivermectin. Through this study, the patient data generated, will be entered into a predesigned proforma, and patient confidentiality shall be strictly maintained.

Bibliography

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7.         Mastrangelo E, Pezzullo M, De Burghgraeve T, Kaptein S, Pastorino B, Dallmeier K, et al. Ivermectin is a potent inhibitor of flavivirus replication specifically targeting NS3 helicase activity: new prospects for an old drug. J Antimicrob Chemother. 2012 Aug;67(8):1884–94.

8.         Götz V, Magar L, Dornfeld D, Giese S, Pohlmann A, Höper D, et al. Influenza A viruses escape from MxA restriction at the expense of efficient nuclear vRNP import. Sci Rep. 2016 Mar 18;6:23138.

9.         Lundberg L, Pinkham C, Baer A, Amaya M, Narayanan A, Wagstaff KM, et al. Nuclear import and export inhibitors alter capsid protein distribution in mammalian cells and reduce Venezuelan Equine Encephalitis Virus replication. Antiviral Res. 2013 Dec;100(3):662–72.

10.       Mectizan Donation Program Annual Highlights 2017 [Internet]. Available from: https://mectizan.org/wp-content/uploads/2018/06/MDP_AH17_English.pdf

11.       The Ivermectin Roadmappers  null. A Roadmap for the Development of Ivermectin as a Complementary Malaria Vector Control Tool. Am J Trop Med Hyg. 2020;102(2s):3–24.