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All Studies   All Outcomes    Recent:   

Virologic Outcomes with Molnupiravir in Non-hospitalized Adult Patients with COVID-19 from the Randomized, Placebo-Controlled MOVe-OUT Trial

Strizki et al., Infectious Diseases and Therapy, doi:10.1007/s40121-023-00891-1, MOVe-OUT, NCT04575597
Nov 2023  
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Virological outcomes for the MOVe-OUT trial. Results are shown with the main paper1.
Concerns have been raised that the mutagenic mechanism of action may create dangerous variants or cause cancer2-10. Multiple analyses have identified variants potentially created by molnupiravir11-14.
Strizki et al., 23 Nov 2023, Double Blind Randomized Controlled Trial, placebo-controlled, multiple countries, peer-reviewed, 10 authors, study period May 2021 - November 2021, average treatment delay 4.0 days, trial NCT04575597 (history) (MOVe-OUT). Contact: julie.strizki@merck.com.
This PaperMolnupiravirAll
Virologic Outcomes with Molnupiravir in Non-hospitalized Adult Patients with COVID-19 from the Randomized, Placebo-Controlled MOVe-OUT Trial
Julie M Strizki, Jay A Grobler, Nicholas Murgolo, Arthur Fridman, Matthew G Johnson, Jiejun Du, Patricia Carmelitano, Michelle L Brown, Amanda Paschke, Carisa De Anda
Infectious Diseases and Therapy, doi:10.1007/s40121-023-00891-1
Introduction: The randomized, placebo-controlled, double-blind MOVe-OUT trial demonstrated molnupiravir (800 mg every 12 h for 5 days) as safe and effective for outpatient treatment of mild-to-moderate COVID-19, significantly reducing the risk of hospitalization/ death in high-risk adults. At the time of that report, virologic assessments from the trial were partially incomplete as a result of their timeintensive nature. Here we present final results from all prespecified virology endpoints in MOVe-OUT based on the full trial dataset.
Supplementary Information The online version contains supplementary material available at https:// doi.org/10.1007/s40121-023-00891- MSD), at the time the study was conducted. Jiejun Du is currently an employee of Moderna, and Jay A. Grobler is currently an employee of Pfizer Inc. Ethical Approval. Our company's approach to the conduct of clinical trials is in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with Good Clinical Practice and the applicable regulatory requirement(s). The trial was conducted in accordance with principles of Good Clinical Practice and was approved by the appropriate institutional Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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' '2022;386(6):509–20.', 'journal-title': 'N Engl J Med'}, { 'issue': '8', 'key': '891_CR28', 'doi-asserted-by': 'publisher', 'first-page': '1126', 'DOI': '10.7326/M22-0729', 'volume': '175', 'author': 'MG Johnson', 'year': '2022', 'unstructured': 'Johnson MG, Puenpatom A, Moncada PA, et al. Effect of molnupiravir on ' 'biomarkers, respiratory interventions, and medical services in COVID-19: ' 'a randomized, placebo-controlled trial. Ann Intern Med. ' '2022;175(8):1126–34.', 'journal-title': 'Ann Intern Med'}, { 'key': '891_CR29', 'doi-asserted-by': 'publisher', 'author': 'Y Caraco', 'year': '2022', 'unstructured': 'Caraco Y, Crofoot GE, Moncada PA, et al. Phase\xa02/3 trial of ' 'molnupiravir for treatment of COVID-19 in nonhospitalized adults. NEJM ' 'Evid. 2022. https://doi.org/10.1056/EVIDoa2100043.', 'journal-title': 'NEJM Evid', 'DOI': '10.1056/EVIDoa2100043'}, { 'issue': '1', 'key': '891_CR30', 'doi-asserted-by': 'publisher', 'first-page': '71', 'DOI': '10.1186/s12985-021-01542-y', 'volume': '18', 'author': 'ST Sonnleitner', 'year': '2021', 'unstructured': 'Sonnleitner ST, Dorighi J, Jansen B, et al. An in vitro model for ' 'assessment of SARS-CoV-2 infectivity by defining the correlation between ' 'virus isolation and quantitative PCR value: isolation success of ' 'SARS-CoV-2 from oropharyngeal swabs correlates negatively with Cq value. ' 'Virol J. 2021;18(1):71.', 'journal-title': 'Virol J'}, { 'key': '891_CR31', 'doi-asserted-by': 'publisher', 'DOI': '10.1016/j.jcv.2021.104879', 'volume': '141', 'author': 'AK Singh', 'year': '2021', 'unstructured': 'Singh AK, Stellrecht KA, Arunachalam T, et al. Lack of active SARS-CoV-2 ' 'virus in a subset of PCR-positive COVID-19 congregate care patients. J ' 'Clin Virol. 2021;141:104879.', 'journal-title': 'J Clin Virol'}, { 'key': '891_CR32', 'doi-asserted-by': 'publisher', 'author': 'TC Jones', 'year': '2021', 'unstructured': 'Jones TC, Biele G, Muhlemann B, et al. Estimating infectiousness ' 'throughout SARS-CoV-2 infection course. Science. 2021. ' 'https://doi.org/10.1126/science.abi5273.', 'journal-title': 'Science', 'DOI': '10.1126/science.abi5273'}, { 'issue': '7809', 'key': '891_CR33', 'doi-asserted-by': 'publisher', 'first-page': '465', 'DOI': '10.1038/s41586-020-2196-x', 'volume': '581', 'author': 'R Wölfel', 'year': '2020', 'unstructured': 'Wölfel R, Corman VM, Guggemos W, et al. Virological assessment of ' 'hospitalized patients with COVID-2019. Nature. 2020;581(7809):465–9.', 'journal-title': 'Nature'}, { 'issue': '67', 'key': '891_CR34', 'doi-asserted-by': 'publisher', 'first-page': '3773', 'DOI': '10.21105/joss.03773', 'volume': '6', 'author': 'I Aksamentov', 'year': '2021', 'unstructured': 'Aksamentov I, Roemer C, Hodcroft EB, et al. Nextclade: clade assignment, ' 'mutation calling and quality control for viral genomes. J Open Source ' 'Softw. 2021;6(67):3773.', 'journal-title': 'J Open Source Softw'}, { 'issue': '2', 'key': '891_CR35', 'doi-asserted-by': 'publisher', 'first-page': '183', 'DOI': '10.1016/S1473-3099(22)00644-2', 'volume': '23', 'author': 'SH Khoo', 'year': '2023', 'unstructured': '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\xa02 trial. Lancet Infect Dis. 2023;23(2):183–95.', 'journal-title': 'Lancet Infect Dis'}, { 'issue': '1', 'key': '891_CR36', 'doi-asserted-by': 'publisher', 'first-page': '7284', 'DOI': '10.1038/s41467-022-34839-9', 'volume': '13', 'author': 'I Donovan-Banfield', 'year': '2022', 'unstructured': 'Donovan-Banfield I, Penrice-Randal R, Goldswain H, et al. ' 'Characterisation of SARS-CoV-2 genomic variation in response to ' 'molnupiravir treatment in the AGILE phase IIa clinical trial. Nat ' 'Commun. 2022;13(1):7284.', 'journal-title': 'Nat Commun'}, { 'issue': '628', 'key': '891_CR37', 'doi-asserted-by': 'publisher', 'first-page': 'eab17430', 'DOI': '10.1126/scitranslmed.abl7430', 'volume': '14', 'author': 'WA Fischer 2nd', 'year': '2022', 'unstructured': 'Fischer WA 2nd, Eron JJ Jr, Holman W, et al. A phase\xa02a 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):eab17430.', 'journal-title': 'Sci Transl Med'}, { 'issue': '6', 'key': '891_CR38', 'doi-asserted-by': 'publisher', 'first-page': '1337', 'DOI': '10.1002/cpt.2895', 'volume': '113', 'author': 'A Chawla', 'year': '2023', 'unstructured': 'Chawla A, Birger R, Wan H, et al. Factors influencing COVID-19 risk: ' 'insights from molnupiravir exposure-response modeling of clinical ' 'outcomes. Clin Pharmacol Ther. 2023;113(6):1337–45.', 'journal-title': 'Clin Pharmacol Ther'}, { 'issue': '22', 'key': '891_CR39', 'doi-asserted-by': 'publisher', 'first-page': '2249', 'DOI': '10.1001/jama.2020.8259', 'volume': '323', 'author': 'N Sethuraman', 'year': '2020', 'unstructured': 'Sethuraman N, Jeremiah SS, Ryo A. Interpreting diagnostic tests for ' 'SARS-CoV-2. JAMA. 2020;323(22):2249–51.', 'journal-title': 'JAMA'}, { 'issue': '1', 'key': '891_CR40', 'doi-asserted-by': 'publisher', 'first-page': 'e13', 'DOI': '10.1016/S2666-5247(20)30172-5', 'volume': '2', 'author': 'M Cevik', 'year': '2021', 'unstructured': 'Cevik M, Tate M, Llloyd O, et al. SARS-CoV-2, SARS-CoV, and MERS-CoV ' 'viral load dynamics, duration of viral shedding, and infectiousness: a ' 'systematic review and meta-analysis. Lancet Microbe. 2021;2(1):e13–22.', 'journal-title': 'Lancet Microbe'}, { 'issue': '3', 'key': '891_CR41', 'first-page': '147', 'volume': '21', 'author': 'O Puhach', 'year': '2023', 'unstructured': 'Puhach O, Meyer B, Eckerle I. SARS-CoV-2 viral load and shedding ' 'kinetics. Nat Rev Microbiol. 2023;21(3):147–61.', 'journal-title': 'Nat Rev Microbiol'}, { 'issue': '17', 'key': '891_CR42', 'doi-asserted-by': 'publisher', 'first-page': '2769', 'DOI': '10.1016/j.vaccine.2023.03.044', 'volume': '41', 'author': 'S-W Kang', 'year': '2023', 'unstructured': 'Kang S-W, Park H, Kim JY, et al. Comparison of culture-competent virus ' 'shedding duration of SARS-CoV-2 Omicron variant in regard to vaccination ' 'status: a prospective cohort study. Vaccine. 2023;41(17):2769–72.', 'journal-title': 'Vaccine'}, { 'issue': '3', 'key': '891_CR43', 'doi-asserted-by': 'publisher', 'first-page': '275', 'DOI': '10.1056/NEJMc2202092', 'volume': '387', 'author': 'J Boucau', 'year': '2022', 'unstructured': 'Boucau J, Marino C, Regan J, et al. Duration of shedding of culturable ' 'virus in SARS-CoV-2 Omicron (BA.1) infection. N Engl J Med. ' '2022;387(3):275–7.', 'journal-title': 'N Engl J Med'}, { 'issue': '5', 'key': '891_CR44', 'doi-asserted-by': 'publisher', 'first-page': '468', 'DOI': '10.1056/NEJMc2207519', 'volume': '387', 'author': 'E Takashita', 'year': '2022', 'unstructured': 'Takashita E, Yamayoshi S, Simon V, et al. Efficacy of antibodies and ' 'antiviral drugs against Omicron BA.2.12.1, BA.4, and BA.5 subvariants. N ' 'Engl J Med. 2022;387(5):468–70.', 'journal-title': 'N Engl J Med'}, { 'key': '891_CR45', 'unstructured': 'European Medicines Agency. Withdrawal assessment report for Lagevrio. ' 'First published 08 September, 2023. Amsterdam: EMA. 2023. ' 'https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/lagevrio. ' 'Accessed 24 Sept 2023.'}, { 'key': '891_CR46', 'doi-asserted-by': 'publisher', 'author': 'JR Arribas', 'year': '2022', 'unstructured': 'Arribas JR, Bhagani S, Lobo SM, et al. Randomized trial of molnupiravir ' 'or placebo in patients hospitalized with Covid-19. NEJM Evid. 2022. ' 'https://doi.org/10.1056/EVIDoa2100044.', 'journal-title': 'NEJM Evid', 'DOI': '10.1056/EVIDoa2100044'}, { 'key': '891_CR47', 'doi-asserted-by': 'publisher', 'DOI': '10.1136/bmj-2022-072705', 'volume': '380', 'author': 'Y Xie', 'year': '2023', 'unstructured': 'Xie Y, Bowe B, Al-Aly Z. Molnupiravir and risk of hospital admission or ' 'death in adults with Covid-19: emulation of a randomized target trial ' 'using electronic health records. BMJ. 2023;380: e072705.', 'journal-title': 'BMJ'}, { 'issue': '10359', 'key': '891_CR48', 'doi-asserted-by': 'publisher', 'first-page': '1213', 'DOI': '10.1016/S0140-6736(22)01586-0', 'volume': '400', 'author': 'CHK Wong', 'year': '2022', 'unstructured': 'Wong CHK, Au ICH, Lau KTK, et al. Real-world effectiveness of ' 'molnupiravir and nirmatrelvir plus ritonavir against mortality, ' 'hospitalisation, and in-hospital outcomes among community-dwelling, ' 'ambulatory patients with confirmed SARS-CoV-2 infection during the ' 'Omicron wave in Hong Kong: an observational study. Lancet. ' '2022;400(10359):1213–22.', 'journal-title': 'Lancet'}, { 'key': '891_CR49', 'doi-asserted-by': 'publisher', 'DOI': '10.1016/j.lanwpc.2022.100602', 'volume': '30', 'author': 'AK Wai', 'year': '2023', 'unstructured': 'Wai AK, Chan CY, Cheung AW, et al. Association of molnupiravir and ' 'nirmatrelvir-ritonavir with preventable mortality, hospital admissions ' 'and related avoidable healthcare system cost among high-risk patients ' 'with mild to moderate COVID-19. Lancet Reg Health West Pac. 2023;30: ' '100602.', 'journal-title': 'Lancet Reg Health West Pac'}, { 'key': '891_CR50', 'doi-asserted-by': 'publisher', 'DOI': '10.1136/bmj-2022-074572', 'volume': '381', 'author': 'Y Xie', 'year': '2023', 'unstructured': 'Xie Y, Choi T, Al-Aly Z. Molnupiravir and risk of post-acute sequelae of ' 'Covid-19: cohort study. BMJ. 2023;381:e074572.', 'journal-title': 'BMJ'}, { 'issue': '1', 'key': '891_CR51', 'doi-asserted-by': 'publisher', 'DOI': '10.1002/jmv.28186', 'volume': '95', 'author': 'V Mazzotta', 'year': '2023', 'unstructured': 'Mazzotta V, Lepri AC, Colavita F, et al. Viral load decrease in ' 'SARS-CoV-2 BA.1 and BA.2 Omicron sublineages infection after treatment ' 'with monoclonal antibodies and direct antiviral agents. J Med Virol. ' '2023;95(1):e28186.', 'journal-title': 'J Med Virol'}], 'container-title': 'Infectious Diseases and Therapy', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://link.springer.com/content/pdf/10.1007/s40121-023-00891-1.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://link.springer.com/article/10.1007/s40121-023-00891-1/fulltext.html', 'content-type': 'text/html', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://link.springer.com/content/pdf/10.1007/s40121-023-00891-1.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2023, 11, 23]], 'date-time': '2023-11-23T07:12:43Z', 'timestamp': 1700723563000}, 'score': 1, 'resource': {'primary': {'URL': 'https://link.springer.com/10.1007/s40121-023-00891-1'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2023, 11, 23]]}, 'references-count': 51, 'alternative-id': ['891'], 'URL': 'http://dx.doi.org/10.1007/s40121-023-00891-1', 'relation': {}, 'ISSN': ['2193-8229', '2193-6382'], 'subject': ['Infectious Diseases', 'Microbiology (medical)'], 'container-title-short': 'Infect Dis Ther', 'published': {'date-parts': [[2023, 11, 23]]}, 'assertion': [ { 'value': '11 August 2023', 'order': 1, 'name': 'received', 'label': 'Received', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '31 October 2023', 'order': 2, 'name': 'accepted', 'label': 'Accepted', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '23 November 2023', 'order': 3, 'name': 'first_online', 'label': 'First Online', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, {'order': 1, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Declarations'}}, { 'value': 'Julie M. Strizki, Nicholas Murgolo, Arthur Fridman, Matthew G. Johnson, ' 'Patricia Carmelitano, Michelle L. Brown, Amanda Paschke, and Carisa De Anda are ' 'employees of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., ' 'Rahway, NJ, USA\xa0(MSD), who may own stock and/or hold stock options in Merck ' '& Co., Inc., Rahway, NJ, USA. Jiejun Du and Jay A. Grobler were employees of ' 'Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA\xa0' '(MSD), at the time the study was conducted. Jiejun Du is currently an employee ' 'of Moderna, and Jay A. Grobler is currently an employee of Pfizer Inc.', 'order': 2, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Conflict of Interest'}}, { 'value': 'Our company’s\xa0approach to the conduct of clinical trials is in accordance ' 'with the ethical principles that have their origin in the Declaration of ' 'Helsinki, and that are consistent with Good Clinical Practice and the ' 'applicable regulatory requirement(s). The trial was conducted in accordance ' 'with principles of Good Clinical Practice and was approved by the appropriate ' 'institutional review boards/ethics committees and regulatory agencies at all ' 'institutions/study sites (see Table\xa0S8). Written informed consent was ' 'provided by all participants prior to their enrollment into the trial. No ' 'identifying information for any trial participant is included in the ' 'manuscript. All named authors meet the International Committee of Medical ' 'Journal Editors (ICMJE) criteria for authorship on this publication, take ' 'responsibility for the integrity of the work as a whole, and have given their ' 'approval for this final version to be published.', 'order': 3, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Ethical Approval'}}]}
Late treatment
is less effective
Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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