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. 2022 Sep 16:2200159.
doi: 10.1002/adtp.202200159. Online ahead of print.

Efficacy and Safety of Inosine Pranobex in COVID-19 Patients: A Multicenter Phase 3 Randomized Double-Blind, Placebo-Controlled Trial

Jayanthi C R  1 , Ashok K Swain  2 , Ranganath T Ganga  3 , Dnyaneshwar Halnor  4 , Ajit Avhad  5 , Mohd Saif Khan  6 , Ayan Ghosh  7 , Sumer Sanjiv Choudhary  8 , Anand Namdevrao Yannawar  9 , Shubhangi Despande  10 , Manish Patel  11 , Krishna Prasad Anne  12 , Yogesh Bangar  2
Affiliations

Efficacy and Safety of Inosine Pranobex in COVID-19 Patients: A Multicenter Phase 3 Randomized Double-Blind, Placebo-Controlled Trial

Jayanthi C R et al. Adv Ther (Weinh). .

Abstract

Inosine pranobex (IP), an immunomodulatory agent, is used in the treatment of various viral infections. The results of a phase 3 randomized controlled trial are reported, evaluating the efficacy and safety of IP in the treatment of mild to moderate COVID-19. It includes 416 symptomatic patients with confirmed SARS-CoV-2 infection. In addition to a defined standard of care, patients randomly (1:1) receive either IP 500 mg tablet (IP group) or a matching placebo (placebo group) at 50 mg kg-1 body weight/day rounded to the nearest 500 mg dose (maximum 4 g day-1) administered in 3-4 divided doses for 10 days. Compared to the placebo group, IP group shows significantly higher rates of clinical response (CR) and clinical cure (CC) on Day-6 for both non-hospitalized patients and the total population. IP group shows significantly earlier CR and CC with fewer adverse events and no mortality. Based on these findings and the fact that IP increases natural killer cell-mediated cytotoxicity of virus-infected cells as an early immune response to viral infection and enhances NKG2D ligand expression, it is concluded that IP should be started early to maximize the benefit in mild to moderate COVID-19 patients. (Trial registration number: CTRI/2021/02/030892).

Keywords: COVID‐19; antiviral; efficacy; inosine acedoben dimepranol; inosine pranobex; safety.

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Conflict of interest statement

All the authors, except for A.S. and Y.B., acted as investigators in the clinical trial and have received their investigator's fees for this study. They have received no other funding related to the study. A.S. is an employee of Themis Medicare Limited, India, the sponsor of the study. Y.B. was an employee of Themis Medicare Limited, India when the study was conducted and when the first draft of the manuscript was prepared. He has checked and approved the final version of the manuscript being submitted. M.S.K. has received an honorarium from Themis Medicare Limited, India as a Speaker. All the authors report that they have no other disclosures to make.

Figures

Figure 1
Figure 1
CONSORT Flow diagram showing patient disposition and randomization; a) total patients including both hospitalized and non‐hospitalized patients. b) The non‐hospitalized patient cohort. DSC = defined standard of care.
Figure 2
Figure 2
CR on Day 6 in a) nonhospitalized population and b) total population
Figure 3
Figure 3
CC on Day 6 in a) nonhospitalized population and b) total population
Figure 4
Figure 4
Time to CR and CC in ITT population (n = 414); a) Kaplan–Meier plot for time to CR; median time to CR: 6 days versus 8 days; p < 0.001. b) Kaplan–Meier plot for time to CC; median time to CC: 6 days versus 8 days, p < 0.001. ITT population is the set of all randomized patients in the trial. ITT: Intention‐to‐treat; IP: Inosine pranobex; DSC: defined standard of care.
See this image and copyright information in PMC

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