tetano
Editor, Senior Moderator
J Infect Chemother
. 2021 Aug 25;S1341-321X(21)00239-7.
doi: 10.1016/j.jiac.2021.08.021. Online ahead of print.
Single-dose oral ivermectin in mild and moderate COVID-19 (RIVET-COV): A single-centre randomized, placebo-controlled trial
Anant Mohan[SUP] 1 [/SUP], Pawan Tiwari[SUP] 2 [/SUP], Tejas Menon Suri[SUP] 2 [/SUP], Saurabh Mittal[SUP] 2 [/SUP], Ankit Patel[SUP] 2 [/SUP], Avinash Jain[SUP] 2 [/SUP], Thirumurthy Velpandian[SUP] 3 [/SUP], Ujjalkumar Subhash Das[SUP] 3 [/SUP], Tarun Krishna Boppana[SUP] 2 [/SUP], Ravindra Mohan Pandey[SUP] 4 [/SUP], Sushil Suresh Shelke[SUP] 2 [/SUP], Angel Rajan Singh[SUP] 5 [/SUP], Sushma Bhatnagar[SUP] 6 [/SUP], Shet Masih[SUP] 7 [/SUP], Shelly Mahajan[SUP] 7 [/SUP], Tanima Dwivedi[SUP] 8 [/SUP], Biswajeet Sahoo[SUP] 8 [/SUP], Anuja Pandit[SUP] 6 [/SUP], Shweta Bhopale[SUP] 6 [/SUP], Saurabh Vig[SUP] 6 [/SUP], Ritu Gupta[SUP] 8 [/SUP], Karan Madan[SUP] 2 [/SUP], Vijay Hadda[SUP] 2 [/SUP], Nishkarsh Gupta[SUP] 6 [/SUP], Rakesh Garg[SUP] 6 [/SUP], Ved Prakash Meena[SUP] 9 [/SUP], Randeep Guleria[SUP] 2 [/SUP]
Affiliations
Abstract
Introduction: 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.
Methods: 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).
Results: 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.
Conclusions: 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.
Keywords: COVID-19; Ivermectin; SARS-CoV-2; Viral load.
. 2021 Aug 25;S1341-321X(21)00239-7.
doi: 10.1016/j.jiac.2021.08.021. Online ahead of print.
Single-dose oral ivermectin in mild and moderate COVID-19 (RIVET-COV): A single-centre randomized, placebo-controlled trial
Anant Mohan[SUP] 1 [/SUP], Pawan Tiwari[SUP] 2 [/SUP], Tejas Menon Suri[SUP] 2 [/SUP], Saurabh Mittal[SUP] 2 [/SUP], Ankit Patel[SUP] 2 [/SUP], Avinash Jain[SUP] 2 [/SUP], Thirumurthy Velpandian[SUP] 3 [/SUP], Ujjalkumar Subhash Das[SUP] 3 [/SUP], Tarun Krishna Boppana[SUP] 2 [/SUP], Ravindra Mohan Pandey[SUP] 4 [/SUP], Sushil Suresh Shelke[SUP] 2 [/SUP], Angel Rajan Singh[SUP] 5 [/SUP], Sushma Bhatnagar[SUP] 6 [/SUP], Shet Masih[SUP] 7 [/SUP], Shelly Mahajan[SUP] 7 [/SUP], Tanima Dwivedi[SUP] 8 [/SUP], Biswajeet Sahoo[SUP] 8 [/SUP], Anuja Pandit[SUP] 6 [/SUP], Shweta Bhopale[SUP] 6 [/SUP], Saurabh Vig[SUP] 6 [/SUP], Ritu Gupta[SUP] 8 [/SUP], Karan Madan[SUP] 2 [/SUP], Vijay Hadda[SUP] 2 [/SUP], Nishkarsh Gupta[SUP] 6 [/SUP], Rakesh Garg[SUP] 6 [/SUP], Ved Prakash Meena[SUP] 9 [/SUP], Randeep Guleria[SUP] 2 [/SUP]
Affiliations
- PMID: 34483029
- DOI: 10.1016/j.jiac.2021.08.021
Abstract
Introduction: 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.
Methods: 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).
Results: 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.
Conclusions: 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.
Keywords: COVID-19; Ivermectin; SARS-CoV-2; Viral load.