Antiviral Efficacy and Safety of Molnupiravir Against Omicron Variant Infection: A Randomized Controlled Clinical Trial

Zou, Rongrong1; Peng, Ling1; Shu, Dan1; Zhao, Lei2; Lan, Jianfeng1; Tan, Guoyu1; Peng, Jinghan1; Yang, Xiangyi1; Liu, Miaona1; Zhang, Chenhui1; Yuan, Jing1; Wang, Huxiang1; Li, Song2; Lu, Hongzhou1; Zhong, Wu2; Liu, Yingxia1

2022-06-15

10.3389/fphar.2022.939573

FRONTIERS IN PHARMACOLOGY   Impact Factor & Quartile

1663-9812

Background: The rapid worldwide spread of the Omicron variant of SARS-CoV-2 has unleashed a new wave of COVID-19 outbreaks. The efficacy of molnupiravir, an approved drug, is still unknown in patients infected with the Omicron variant.Objective: Evaluated the antiviral efficacy and safety of molnupiravir in patients infected with SARS-CoV-2 Omicron variant, with symptom duration within 5 days. Methods: We conducted a randomized, controlled trial involving patients with mild or moderate COVID-19. Patients were randomized to orally receive molnupiravir (800 mg) plus basic treatment or only basic treatment for 5 days (BID). The antiviral efficacy of the drug was evaluated using reverse transcriptase polymerase chain reaction. Results: Results showed that the time of viral RNA clearance (primary endpoint) was significantly decreased in the molnupiravir group (median, 9 days) compared to the control group (median, 10 days) (Log-Rank p = 0.0092). Of patients receiving molnupiravir, 18.42% achieved viral RNA clearance on day 5 of treatment, compared to the control group (0%) (p = 0.0092). On day 7, 40.79%, and 6.45% of patients in the molnupiravir and control groups, respectively, achieved viral RNA clearance (p = 0.0004). In addition, molnupiravir has a good safety profile, and no serious adverse events were reported. Conclusion: Molnupiravir significantly accelerated the SARS-CoV-2 Omicron RNA clearance in patients with COVID-19.

Omicron variant SARS-CoV-2 molnupiravir antiviral efficacy clinical trial

SCI

English

First ; Corresponding

National Key Research and Development Project[2021YFC2300704] ; Shenzhen Science and Technology Research and Development Project[JSGG20200207161928126] ; National Science and Technology[2018ZX09711003]

Pharmacology & Pharmacy

Pharmacology & Pharmacy

WOS:000820058300001

FRONTIERS MEDIA SA

Web of Science

1.Southern Univ Sci & Technol, Shenzhen Peoples Hosp 3, Natl Clin Res Ctr Infect Dis, Shenzhen Key Lab Pathogen & Immun,Hosp Affiliated, Shenzhen, Peoples R China
2.Beijing Inst Pharmacol & Toxicol, Natl Engn Res Ctr Emergency Drug, Beijing, Peoples R China

Zou, Rongrong,Peng, Ling,Shu, Dan,et al. Antiviral Efficacy and Safety of Molnupiravir Against Omicron Variant Infection: A Randomized Controlled Clinical Trial[J]. FRONTIERS IN PHARMACOLOGY,2022,13.

Zou, Rongrong.,Peng, Ling.,Shu, Dan.,Zhao, Lei.,Lan, Jianfeng.,...&Liu, Yingxia.(2022).Antiviral Efficacy and Safety of Molnupiravir Against Omicron Variant Infection: A Randomized Controlled Clinical Trial.FRONTIERS IN PHARMACOLOGY,13.

Zou, Rongrong,et al."Antiviral Efficacy and Safety of Molnupiravir Against Omicron Variant Infection: A Randomized Controlled Clinical Trial".FRONTIERS IN PHARMACOLOGY 13(2022).