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  • Single-dose oral ivermectin...
    Mohan, Anant; Tiwari, Pawan; Suri, Tejas Menon; Mittal, Saurabh; Patel, Ankit; Jain, Avinash; Velpandian, Thirumurthy; Das, Ujjalkumar Subhash; Boppana, Tarun Krishna; Pandey, Ravindra Mohan; Shelke, Sushil Suresh; Singh, Angel Rajan; Bhatnagar, Sushma; Masih, Shet; Mahajan, Shelly; Dwivedi, Tanima; Sahoo, Biswajeet; Pandit, Anuja; Bhopale, Shweta; Vig, Saurabh; Gupta, Ritu; Madan, Karan; Hadda, Vijay; Gupta, Nishkarsh; Garg, Rakesh; Meena, Ved Prakash; Guleria, Randeep

    Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy, 12/2021, Letnik: 27, Številka: 12
    Journal Article

    Ivermectin is an antiparasitic drug which has in-vitro efficacy in reducing severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) viral load. Hence, Ivermectin is under investigation as a repurposed agent for treating COVID-19. In this pilot, double blind, randomized controlled trial, hospitalized patients with mild-to-moderate COVID-19 were assigned to a single oral administration of an elixir formulation of Ivermectin at either 24 mg or 12 mg dose, or placebo in a 1:1:1 ratio. The co-primary outcomes were conversion of RT-PCR to negative result and the decline of viral load at day 5 of enrolment. Safety outcomes included total and serious adverse events. The primary outcomes were assessed in patients who had positive RT-PCR at enrolment (modified intention-to-treat population). Safety outcomes were assessed in all patients who received the intervention (intention-to-treat population). Among the 157 patients randomized, 125 were included in modified intention-to-treat analysis. 40 patients each were assigned to Ivermectin 24 mg and 12 mg, and 45 patients to placebo. The RT-PCR negativity at day 5 was higher in the two Ivermectin arms but failed to attain statistical significance (Ivermectin 24 mg, 47.5%; 12 mg arm, 35.0%; and placebo arm, 31.1%; p-value = 0.30). The decline of viral load at day 5 was similar in each arm. No serious adverse events occurred. In patients with mild and moderate COVID-19, a single oral administration of Ivermectin did not significantly increase either the negativity of RT-PCR or decline in viral load at day 5 of enrolment compared with placebo.