Efficacy and safety of Molnupiravir in the treatment of COVID-19: a meta-analysis_Chinese Journal of Evidence-Based Medicine

Authors：

LIANG Yankun ¹ ,  LYU Jun ^2,3 , SU Ling ¹

1. College of Pharmacy, Jinan University, Guangzhou 511443, P. R. China;
2. Department of Clinical Research, the First Affiliated Hospital of Jinan University, Guangzhou 510630, P. R. China;
3. Guangdong Provincial Key Laboratory of Traditional Chinese Medicine Information, Guangzhou 510632, P. R. China;

Corresponding author：

LYU Jun, Email: lyujun2020@jnu.edu.cn

Keywords：

Molnupiravir; Safety; Efficacy; Meta-analysis; Systematic review; Randomized controlled trials

DOI：

10.7507/1672-2531.202308092

Video：

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Objective To systematically review the efficacy and safety of Molnupiravir in the treatment of COVID-19. Methods The CNKI, VIP, WanFang Data, PubMed, Web of Science, Cochrane Library, and Epistemonikos COVID-19 L·OVE databases were electronically searched to collect randomized controlled trials (RCTs) related to Molnupiravir therapy for COVID-19 from inception to July, 2023. Two reviewers independently screened literature, extracted data and assessed the risk of bias of the included studies. Meta-analysis was then performed by using RevMan 5.4 software. Results A total of 9 RCTs involving 32 086 patients were included. The meta-analysis results revealed that no significant differences were observed in the 28-29 day hospitalization rate, the 28-29 day mortality rate, 14-15 day PCR test conversion rate, or adverse event incidence between the two groups. However, there was a significant increase in adverse events related to four types of systemic organ diseases in the Monolaurin group. Conclusion Current evidence shows that the safety profile of Monolaurin and its potential benefits for COVID-19 patients with a high risk of progressing to severe illness is unclear. Due to the limited quality and quantity of the included studies, more high quality studies are needed to verify the above conclusion.

Citation： LIANG Yankun, LYU Jun, SU Ling. Efficacy and safety of Molnupiravir in the treatment of COVID-19: a meta-analysis. Chinese Journal of Evidence-Based Medicine, 2024, 24(1): 43-48. doi: 10.7507/1672-2531.202308092 Copy

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2.	Umakanthan S, Ramlagan A, Ramlal C, et al. COVID-19 awareness among undergraduate medical students in Trinidad: a cross-sectional study: 2. Inter Med Edu, 2022, 1(2): 22-32.
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19.	Zou R, Peng L, Shu D, et al. Antiviral efficacy and safety of molnupiravir against Omicron variant infection: a randomized controlled clinical trial. Front Pharmacol, 2022, 13: 939573.
20.	Tippabhotla SK, Lahiri Dr S. Efficacy and safety of molnupiravir for the treatment of non-hospitalized adults with mild COVID-19: a randomized, open-label, parallel-group phase 3 trial. SSRN J, 2022.
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24.	Villamarín M, Márquez-Algaba E, Esperalba J, et al. Preliminary clinical experience of molnupiravir to prevent progression of COVID-19 in kidney transplant recipients. Transplantation, 2022, 106(11): 2200-2204.
25.	浙江省医院药事管理质控中心. 莫诺拉韦胶囊的临床问题及药学建议—新型冠状病毒感染临床用药建议(二). 中国合理用药探索, 2023, 20(2): 54-55.
26.	Lamontagne F, Agarwal A, Rochwerg B, et al. A living WHO guideline on drugs for COVID-19. BMJ, 2020, 370: m3379.

1. Umakanthan S, Patil S, Subramaniam N, et al. COVID-19 vaccine hesitancy and resistance in India explored through a population-based longitudinal survey. Vaccines (Basel), 2021, 9(10): 1064.
2. Umakanthan S, Ramlagan A, Ramlal C, et al. COVID-19 awareness among undergraduate medical students in Trinidad: a cross-sectional study: 2. Inter Med Edu, 2022, 1(2): 22-32.
3. Rabie AM, Abdalla M. Evaluation of a series of nucleoside analogs as effective anticoronaviral-2 drugs against the Omicron-B. 1.1. 529/BA. 2 subvariant: a repurposing research study. Med Chem Res, 2023, 32(2): 326-341.
4. Tian L, Pang Z, Li M, et al. Molnupiravir and its antiviral activity against COVID-19. Front Immunol, 2022, 13: 855496.
5. 国家中医药管理局, 国家卫生健康委员会. 新型冠状病毒感染重症病例诊疗方案(试行第四版). 中国病毒病杂志, 2023, 13(2): 111-114.
6. Tian F, Feng Q, Chen Z. Efficacy and safety of molnupiravir treatment for COVID-19: a systematic review and meta-analysis of randomized controlled trials. Int J Antimicrob Agents, 2023, 62(2): 106870.
7. Sun M, Lai H, Huang J, et al. Molnupiravir for the treatment of non-severe COVID-19: a systematic review and meta-analysis of 14 randomized trials with 34 570 patients. J Antimicrob Chemother, 2023, 78(9): 2131-2139.
8. Huang PY, Liu TH, Wu JY, et al. Clinical efficacy and safety of molnupiravir for nonhospitalized and hospitalized patients with COVID-19: a systematic review and meta-analysis of randomized control trials. J Med Virol, 2023, 95(3): e28621.
9. Fatima M, Azeem S, Saeed J, et al. Efficacy and safety of molnupiravir for COVID-19 patients. Eur J Intern Med, 2022, 102: 118-121.
10. Malin JJ, Weibel S, Gruell H, et al. Efficacy and safety of molnupiravir for the treatment of SARS-CoV-2 infection: a systematic review and meta-analysis. J Antimicrob Chemother, 2023, 78(7): 1586-1598.
11. GAO Y, LIU M, LI Z, et al. Molnupiravir for treatment of adults with mild or moderate COVID-19: a systematic review and meta-analysis of randomised controlled trials. Clin Micro Infect, 2023: S1198743X23001854.
12. Amani B, Zareei S, Amani B. Rapid review and meta-analysis of adverse events associated with molnupiravir in patients with COVID-19. Br J Clin Pharmacol, 2022, 88(10): 4403-4411.
13. Pitre T, Van Alstine R, Chick G, et al. Antiviral drug treatment for nonsevere COVID-19: a systematic review and network meta-analysis. CMAJ, 2022, 194(28): E969-E980.
14. Anonymous. Epistemonikos: database of the best evidence-based health care. 2023.
15. Jayk Bernal A, Gomes da Silva MM, Musungaie DB, et al. Molnupiravir for oral treatment of Covid-19 in Nonhospitalized patients. N Engl J Med, 2022, 386(6): 509-520.
16. Butler CC, Hobbs FDR, Gbinigie OA, et al. Molnupiravir plus usual care versus usual care alone as early treatment for adults with COVID-19 at increased risk of adverse outcomes (PANORAMIC): an open-label, platform-adaptive randomised controlled trial. Lancet, 2023, 401(10373): 281-293.
17. Caraco Y, Crofoot GE, Moncada PA, et al. Phase 2/3 trial of molnupiravir for treatment of Covid-19 in Nonhospitalized adults. NEJM Evid, 2022, 1(2): 2100013.
18. Fischer WA, Eron JJ, Holman W, et al. A phase 2a clinical trial of molnupiravir in patients with COVID-19 shows accelerated SARS-CoV-2 RNA clearance and elimination of infectious virus. Sci Transl Med, 2022, 14(628): eabl7430.
19. Zou R, Peng L, Shu D, et al. Antiviral efficacy and safety of molnupiravir against Omicron variant infection: a randomized controlled clinical trial. Front Pharmacol, 2022, 13: 939573.
20. Tippabhotla SK, Lahiri Dr S. Efficacy and safety of molnupiravir for the treatment of non-hospitalized adults with mild COVID-19: a randomized, open-label, parallel-group phase 3 trial. SSRN J, 2022.
21. Sinha S, N K, Suram VK, et al. Efficacy and Safety of molnupiravir in mild COVID-19 patients in India. Cureus, 2022, 14(11): e31508.
22. Khoo SH, FitzGerald R, Saunders G, et al. Molnupiravir versus placebo in unvaccinated and vaccinated patients with early SARS-CoV-2 infection in the UK (AGILE CST-2): a randomised, placebo-controlled, double-blind, phase 2 trial. Lancet Infect Dis, 2023, 23(2): 183-195.
23. Arribas JR, Bhagani S, Lobo SM, et al. Randomized trial of molnupiravir or placebo in patients hospitalized with Covid-19. NEJM Evid, 2022, 1(2): 2100044.
24. Villamarín M, Márquez-Algaba E, Esperalba J, et al. Preliminary clinical experience of molnupiravir to prevent progression of COVID-19 in kidney transplant recipients. Transplantation, 2022, 106(11): 2200-2204.
25. 浙江省医院药事管理质控中心. 莫诺拉韦胶囊的临床问题及药学建议—新型冠状病毒感染临床用药建议(二). 中国合理用药探索, 2023, 20(2): 54-55.
26. Lamontagne F, Agarwal A, Rochwerg B, et al. A living WHO guideline on drugs for COVID-19. BMJ, 2020, 370: m3379.

Chinese Journal of Evidence-Based Medicine

Efficacy and safety of Molnupiravir in the treatment of COVID-19: a meta-analysis

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