AUTHOR=Zou Rongrong , Peng Ling , Shu Dan , Zhao Lei , Lan Jianfeng , Tan Guoyu , Peng Jinghan , Yang Xiangyi , Liu Miaona , Zhang Chenhui , Yuan Jing , Wang Huxiang , Li Song , Lu Hongzhou , Zhong Wu , Liu Yingxia 

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

JOURNAL=Frontiers in Pharmacology

VOLUME=13

YEAR=2022

URL=https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2022.939573

DOI=10.3389/fphar.2022.939573

ISSN=1663-9812

ABSTRACT=<p><bold>Background:</bold> 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.</p><p><bold>Objective:</bold> Evaluated the antiviral efficacy and safety of molnupiravir in patients infected with SARS-CoV-2 Omicron variant, with symptom duration within 5 days.</p><p><bold>Methods:</bold> 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.</p><p><bold>Results:</bold> 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 <italic>p</italic> = 0.0092). Of patients receiving molnupiravir, 18.42% achieved viral RNA clearance on day 5 of treatment, compared to the control group (0%) (<italic>p</italic> = 0.0092). On day 7, 40.79%, and 6.45% of patients in the molnupiravir and control groups, respectively, achieved viral RNA clearance (<italic>p</italic> = 0.0004). In addition, molnupiravir has a good safety profile, and no serious adverse events were reported.</p><p><bold>Conclusion:</bold> Molnupiravir significantly accelerated the SARS-CoV-2 Omicron RNA clearance in patients with COVID-19.</p><p><bold>Clinical Trial Registration:</bold> [<ext-link ext-link-type="uri" xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="http://chictr.org.cn">chictr.org.cn</ext-link>], identifier [ChiCTR2200056817].</p>