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All Studies   All Outcomes    Recent:   
0 0.5 1 1.5 2+ Hospitalization 46% Improvement Relative Risk Improvement, day 14 46% Improvement, day 10 52% Improvement, day 5 25% Viral clearance, day 14 59% Viral clearance, day 10 81% Viral clearance, day 5 78% Molnupiravir  Tippabhotla et al.  EARLY TREATMENT  RCT Is early treatment with molnupiravir beneficial for COVID-19? RCT 1,220 patients in India (July - August 2021) Greater improvement (p<0.0001) and improved viral clearance (p<0.0001) c19early.org Tippabhotla et al., SSRN Electronic J., Feb 2022 Favors molnupiravir Favors control

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

Tippabhotla et al., SSRN Electronic Journal, doi:10.2139/ssrn.4042673
Feb 2022  
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RCT 1,220 patients in India, showing lower risk of hospitalization and improved recovery with treatment. CTRI/2021/07/034588.
Concerns have been raised that the mutagenic mechanism of action may create dangerous variants or cause cancer Chamod, Gruber, Hadj Hassine, Huntsman, Marikawa, Swanstrom, Waters, Zhou, Zibat. Multiple analyses have identified variants potentially created by molnupiravir Fountain-Jones, Kosakovsky Pond, Sanderson, twitter.com.
risk of hospitalization, 46.2% lower, RR 0.54, p = 0.26, treatment 7 of 610 (1.1%), control 13 of 610 (2.1%), NNT 102, day 28.
risk of no improvement, 46.4% lower, RR 0.54, p < 0.001, treatment 67 of 610 (11.0%), control 125 of 610 (20.5%), NNT 11, day 14.
risk of no improvement, 52.3% lower, RR 0.48, p < 0.001, treatment 199 of 610 (32.6%), control 417 of 610 (68.4%), NNT 2.8, day 10.
risk of no improvement, 24.8% lower, RR 0.75, p < 0.001, treatment 433 of 610 (71.0%), control 576 of 610 (94.4%), NNT 4.3, day 5.
risk of no viral clearance, 59.2% lower, RR 0.41, p < 0.001, treatment 42 of 610 (6.9%), control 103 of 610 (16.9%), NNT 10.0, day 14.
risk of no viral clearance, 81.0% lower, RR 0.19, p < 0.001, treatment 62 of 610 (10.2%), control 327 of 610 (53.6%), NNT 2.3, day 10.
risk of no viral clearance, 77.6% lower, RR 0.22, p < 0.001, treatment 113 of 610 (18.5%), control 505 of 610 (82.8%), NNT 1.6, day 5.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Tippabhotla et al., 24 Feb 2022, Randomized Controlled Trial, India, peer-reviewed, 5 authors, study period 1 July, 2021 - 24 August, 2021, average treatment delay 3.0 days.
This PaperMolnupiravirAll
Background: Molnupiravir is an oral prodrug with antiviral activity against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). Molnupiravir was initially developed for Influenza treatment, is being repurposed for the treatment of COVID-19. This study evaluates the efficacy and safety of molnupiravir in addition to the standardof-care (SOC) for the treatment of non-hospitalized patients with mild COVID-19. Methods: In this phase 3, randomized, open-label, parallel-group study, 1220 patients with laboratory-confirmed (RT-PCR positive) SARS-CoV-2 infection were enrolled across 16 centres in India and 7.3% (90/1220) patients were with one risk factor (i.e. hypertension, diabetes mellitus, obesity, hypothyroidism, hyperthyroidism) presenting a risk for progression to severe COVID-19. Non-hospitalized adults with mild COVID-19 were randomized to receive either molnupiravir 800 mg (200 mg x 4 capsules administered orally every 12 hours for 5 days) with SOC or SOC alone and followed up at day 5 (end of treatment, and days 10, 14 and 28. Standard of care was provided as per the clinical guidance for management of adult COVID-19 patients by the Government of India or as per the Investigator's discretion. The primary endpoint was the rate of hospitalization of patients from randomization till day 14. Secondary endpoints included rate of hospitalization of patients from randomization up to day 28; clinical improvement (2-point decrease in 11-point WHO Clinical Progression Scale) at days 5, 10, and 14; SARS-CoV-2 RT-PCR negativity at the end of treatment; and mortality rate at day 14 and day 28. The study is registered with the Clinical Trials Registry of India, CTRI/2021/07/034588.
References
Businesswire, Merck and Ridgeback Biotherapeutics Provide Update on Results from MOVe-OUT Study of Molnupiravir, an Investigational Oral Antiviral Medicine, in At Risk Adults With Mild-to-Moderate COVID-19
Fischer, Eron, Holman, Cohen, Fang et al., Molnupiravir, an Oral Antiviral Treatment for COVID-19, doi:10.1101/2021.06.17.21258639
Kabinger, Stiller, Schmitzová, Mechanism of molnupiravir-induced SARS-CoV-2 mutagenesis, Nat Struct Mol Biol, doi:10.1038/s41594-021-00651-0
Kenilworth, Miami, Merck and Ridgeback to Present Phase 3 Data for Molnupiravir, an Investigational Oral COVID-19 Antiviral Medicine
Khoo, Fitzgerald, Fletcher, Ewings, Jaki et al., Optimal dose and safety of molnupiravir in patients with early SARS-CoV-2: a Phase I, open-label, dose-escalating, randomized controlled study, J Antimicrob Chemother, doi:10.1093/jac/dkab318
Mahase, Covid-19: UK becomes first country to authorise antiviral molnupiravir, BMJ, doi:10.1136/bmj.n2697
Merck, Merck and Ridgeback Biotherapeutics provide update on progress of clinical development program for molnupiravir, an investigational oral therapeutic for the treatment of mild-to-moderate COVID-19
Painter, Holman, Bush, Almazedi, Malik et al., Human Safety, Tolerability, and Pharmacokinetics of Molnupiravir, a Novel Broad-Spectrum Oral Antiviral Agent with Activity Against SARS-CoV-2, Antimicrob Agents Chemother, doi:10.1128/AAC.02428-20
Painter, Sheahan, Baric, Holman, Donovan et al., Reduction in infectious SARS-CoV-2 in treatment study of COVID-19 with molnupiravir
Singh, Singh, Singh, Misra, Molnupiravir in COVID-19: A systematic review of literaturef, Diabetes Metab Syndr, doi:10.1016/j.dsx.2021.102329
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