Efficacy and Safety of Inosine Pranobex in COVID‐19 Patients: A Multicenter Phase 3 Randomized Double‐Blind, Placebo‐Controlled Trial
et al., Advanced Therapeutics, doi:10.1002/adtp.202200159, CTRI/2021/02/030892, Sep 2022
RCT 416 mild-to-moderate COVID-19 patients (both hospitalized and non-hospitalized) showing improved recovery with inosine pranobex.
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risk of no recovery, 27.4% lower, RR 0.73, p = 0.003, treatment 79 of 204 (38.7%), control 112 of 210 (53.3%), NNT 6.8, mid-recovery, day 6.
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risk of no recovery, 6.4% lower, RR 0.94, p = 1.00, treatment 10 of 204 (4.9%), control 11 of 210 (5.2%), NNT 297, day 11.
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risk of no improvement, 32.6% lower, RR 0.67, p < 0.001, treatment 72 of 204 (35.3%), control 110 of 210 (52.4%), NNT 5.9, mid-recovery, day 6.
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risk of no improvement, 14.4% higher, RR 1.14, p = 0.82, treatment 10 of 204 (4.9%), control 9 of 210 (4.3%), day 11.
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| Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates |
Jayanthi et al., 16 Sep 2022, Double Blind Randomized Controlled Trial, placebo-controlled, India, peer-reviewed, 13 authors, study period 8 February, 2021 - 16 June, 2021, trial CTRI/2021/02/030892.
Contact: ashok.swain@themismedicare.com.
Inosine pranobex is an orally administered small-molecule immunomodulator with broad antiviral activity. It enhances natural killer cell cytotoxicity and T-lymphocyte function and promotes Th1-type cytokine responses, thereby augmenting host antiviral defenses.
Abstract:
Efficacy and Safety of Inosine Pranobex in COVID-19 Patients: A Multicenter Phase 3 Randomized Double-Blind, Placebo-Controlled Trial
Jayanthi C R, Ashok K Swain,* Ranganath T Ganga, Dnyaneshwar Halnor, Ajit Avhad, Mohd. Saif Khan, Ayan Ghosh, Sumer Sanjiv Choudhary, Anand Namdevrao Yannawar, Shubhangi Despande, Manish Patel, Krishna Prasad Anne, and Yogesh Bangar
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).
J. C R
Faculty of Medicine and Department of Pharmacology Victoria Hospital, Bangalore Medical College and Research Institute KR Road Fort, Bangalore, Karnataka 560002, India
A. K Swain
Medical Services
Themis Medicare Ltd.
11/12, Udyog Nagar, S.V. Road, Goregaon (W), Mumbai, Maharashtra 400104, India
[E-mail: ashok.swain@themismedicare.com](mailto:ashok.swain@themismedicare.com)
R. T Ganga
Department of Pulmonary Medicine
All India Institute of Medical Sciences
Gate No, 1, Great Eastern Rd, opposite Gurudwara, AIIMS Campus,
Tatibandh, Raipur, Chhattisgarh 492099, India
The ORCID identification number(s) for the author(s) of this article can be found under https://doi.org/10.1002/adtp.202200159
DOI: 10.1002/adtp.202200159
D. Halnor
Department of Medicine
Vijay Vallabh Hospital And Medical Research Centre
423, Tirupati Nagar, Phase 1, Virar (West), Dist. Palghar, Bolinj, Maharashtra 401303, India
A. Avhad
Department of Medicine Family Care Hospitals
P.K. Road Opposite Seven Square Academy, Mira Road (East), Thane, Maharashtra 401107, India
M. S. Khan
Department of Critical Care, Trauma and Emergency Medicine Rajendra Institute of Medical Sciences (RIMS)
Bariatu, Ranchi, Jharkhand 834009, India
A. Ghosh
Department of Community Medicine College of Medicine and JNM College Nadia, Kalyani, West Bengal 741235, India
S. S. Choudhary
Department of Pulmonary Medicine
Datta Meghe Medical College and Shalinitai Meghe Hospital and Research Centre, Off campus college of DMIMS deemed University Wanadongri, Hingna, Nagpur, Maharashtra 441110, India
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