Antiviral Efficacy and Safety of Molnupiravir Against Omicron Variant Infection: A Randomized Controlled Clinical Trial
et al., Frontiers in Pharmacology, doi:10.3389/fphar.2022.939573, ChiCTR2200056817, Jun 2022
RCT 116 mild/moderate COVID-19 patients in China, showing improved viral clearance with treatment.
Potential risks of molnupiravir include the creation of dangerous variants, and mutagenicity, carcinogenicity, teratogenicity, and embryotoxicity1-15. Multiple analyses have identified variants potentially created by molnupiravir16-20.
Standard of Care (SOC) for COVID-19 in the study country,
China, is average with moderate efficacy for approved treatments21.
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recovery time, 28.6% lower, relative time 0.71, p = 0.50, treatment 77, control 31.
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time to viral-, 10.0% lower, relative time 0.90, p = 0.009, treatment 76, control 31.
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risk of no viral clearance, 51.1% lower, RR 0.49, p = 0.02, treatment 18 of 76 (23.7%), control 15 of 31 (48.4%), NNT 4.0, day 10.
|
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risk of no viral clearance, 36.7% lower, RR 0.63, p < 0.001, treatment 45 of 76 (59.2%), control 29 of 31 (93.5%), NNT 2.9, day 7.
|
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risk of no viral clearance, 18.4% lower, RR 0.82, p = 0.009, treatment 62 of 76 (81.6%), control 31 of 31 (100.0%), NNT 5.4, day 5.
|
| Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates |
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Zou et al., 15 Jun 2022, Randomized Controlled Trial, China, peer-reviewed, 16 authors, study period 3 March, 2022 - 21 March, 2022, trial ChiCTR2200056817.
Contact: lis.lisong@gmail.com, luhongzhou@szsy.sustech.edu.cn, zhongwu@bmi.ac.cn, szsy_lyx@szsy.sustech.edu.cn.
Antiviral Efficacy and Safety of Molnupiravir Against Omicron Variant Infection: A Randomized Controlled Clinical Trial
Frontiers in Pharmacology, doi:10.3389/fphar.2022.939573
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.
ETHICS STATEMENT The studies involving human participants were reviewed and approved by the Medical Ethics Committee of the Third People's Hospital of Shenzhen (No. 2022-034-02) . The patients/ participants provided their written informed consent to participate in this study.
AUTHOR CONTRIBUTIONS
SUPPLEMENTARY MATERIAL The Supplementary Material for this article can be found online at: https://www.frontiersin.org/articles/10.3389/fphar.2022.939573/ full#supplementary-material Conflict of Interest: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. Publisher's Note: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.
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"abstract": "<jats:p><jats:bold>Background:</jats: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.</jats:p><jats:p><jats:bold>Objective:</jats:bold> Evaluated the antiviral efficacy and safety of molnupiravir in patients infected with SARS-CoV-2 Omicron variant, with symptom duration within 5 days.</jats:p><jats:p><jats:bold>Methods:</jats: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.</jats:p><jats:p><jats:bold>Results:</jats: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 <jats:italic>p</jats:italic> = 0.0092). Of patients receiving molnupiravir, 18.42% achieved viral RNA clearance on day 5 of treatment, compared to the control group (0%) (<jats:italic>p</jats:italic> = 0.0092). On day 7, 40.79%, and 6.45% of patients in the molnupiravir and control groups, respectively, achieved viral RNA clearance (<jats:italic>p</jats:italic> = 0.0004). In addition, molnupiravir has a good safety profile, and no serious adverse events were reported.</jats:p><jats:p><jats:bold>Conclusion:</jats:bold> Molnupiravir significantly accelerated the SARS-CoV-2 Omicron RNA clearance in patients with COVID-19.</jats:p><jats:p><jats:bold>Clinical Trial Registration:</jats:bold> [<jats:ext-link>chictr.org.cn</jats:ext-link>], identifier [ChiCTR2200056817].</jats:p>",
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