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All Studies   All Outcomes    Recent:   
0 0.5 1 1.5 2+ Mortality 77% Improvement Relative Risk Mortality (b) 65% Mortality (c) 67% Mortality (d) 58% Hospitalization -33% Hospitalization (b) -13% Hospitalization (c) -100% Hospitalization (d) 58% Viral clearance 49% Viral clearance (b) 89% Viral clearance (c) 30% Viral clearance (d) -9% Viral clearance (e) 92% Viral clearance (f) 92% Viral clearance (g) 91% Viral clearance (h) 59% Viral clearance (i) 30% Viral clearance (j) 62% Viral clearance (k) -8% Viral clearance (l) 56% Molnupiravir  Fischer et al.  EARLY TREATMENT  RCT Is early treatment with molnupiravir beneficial for COVID-19? RCT 202 patients in the USA (June 2020 - January 2021) Lower mortality (p=0.31) and improved viral clearance (p=0.12), not sig. c19early.org Fischer et al., medRxiv, June 2021 Favors molnupiravir Favors control

Molnupiravir, an Oral Antiviral Treatment for COVID-19

Jun 2021  
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RCT 202 outpatients in the USA showing significantly faster viral clearance, but no significant differences in symptom duration or severity. NCT04405570 (history).
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 death, 76.5% lower, RR 0.23, p = 0.31, treatment 0 of 140 (0.0%), control 1 of 62 (1.6%), NNT 62, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), all.
risk of death, 65.4% lower, RR 0.35, p = 1.00, treatment 0 of 55 (0.0%), control 1 of 62 (1.6%), NNT 62, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), 800mg.
risk of death, 66.7% lower, RR 0.33, p = 1.00, treatment 0 of 62 (0.0%), control 1 of 62 (1.6%), NNT 62, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), 400mg.
risk of death, 57.8% lower, RR 0.42, p = 1.00, treatment 0 of 23 (0.0%), control 1 of 62 (1.6%), NNT 62, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), 200mg.
risk of hospitalization, 32.9% higher, RR 1.33, p = 1.00, treatment 3 of 140 (2.1%), control 1 of 62 (1.6%), all.
risk of hospitalization, 12.7% higher, RR 1.13, p = 1.00, treatment 1 of 55 (1.8%), control 1 of 62 (1.6%), 800mg.
risk of hospitalization, 100% higher, RR 2.00, p = 1.00, treatment 2 of 62 (3.2%), control 1 of 62 (1.6%), 400mg.
risk of hospitalization, 57.8% lower, RR 0.42, p = 1.00, treatment 0 of 23 (0.0%), control 1 of 62 (1.6%), NNT 62, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), 200mg.
risk of no viral clearance, 49.2% lower, RR 0.51, p = 0.12, treatment 10 of 118 (8.5%), control 9 of 54 (16.7%), NNT 12, infectious, day 3, all.
risk of no viral clearance, 88.7% lower, RR 0.11, p = 0.02, treatment 1 of 53 (1.9%), control 9 of 54 (16.7%), NNT 6.8, infectious, day 3, 800mg.
risk of no viral clearance, 30.2% lower, RR 0.70, p = 0.57, treatment 5 of 43 (11.6%), control 9 of 54 (16.7%), NNT 20, infectious, day 3, 400mg.
risk of no viral clearance, 9.1% higher, RR 1.09, p = 1.00, treatment 4 of 22 (18.2%), control 9 of 54 (16.7%), infectious, day 3, 200mg.
risk of no viral clearance, 92.3% lower, RR 0.08, p = 0.004, treatment 1 of 117 (0.9%), control 6 of 54 (11.1%), NNT 9.8, infectious, day 5, all.
risk of no viral clearance, 92.2% lower, RR 0.08, p = 0.03, treatment 0 of 53 (0.0%), control 6 of 54 (11.1%), NNT 9.0, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), infectious, day 5, 800mg.
risk of no viral clearance, 91.4% lower, RR 0.09, p = 0.03, treatment 0 of 42 (0.0%), control 6 of 54 (11.1%), NNT 9.0, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), infectious, day 5, 400mg.
risk of no viral clearance, 59.1% lower, RR 0.41, p = 0.67, treatment 1 of 22 (4.5%), control 6 of 54 (11.1%), NNT 15, infectious, day 5, 200mg.
risk of no viral clearance, 29.5% lower, RR 0.70, p = 0.30, treatment 19 of 137 (13.9%), control 12 of 61 (19.7%), NNT 17, all.
risk of no viral clearance, 61.6% lower, RR 0.38, p = 0.10, treatment 4 of 53 (7.5%), control 12 of 61 (19.7%), NNT 8.2, 800mg.
risk of no viral clearance, 8.3% higher, RR 1.08, p = 1.00, treatment 13 of 61 (21.3%), control 12 of 61 (19.7%), 400mg.
risk of no viral clearance, 55.8% lower, RR 0.44, p = 0.33, treatment 2 of 23 (8.7%), control 12 of 61 (19.7%), NNT 9.1, 200mg.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Fischer et al., 18 Jun 2021, Randomized Controlled Trial, USA, preprint, 18 authors, study period 19 June, 2020 - 25 January, 2021, average treatment delay 4.6 days, trial NCT04405570 (history).
This PaperMolnupiravirAll
Molnupiravir, an Oral Antiviral Treatment for COVID-19
MD William Fischer, MD Joseph J Eron Jr, MD Wayne Holman, MD Myron S Cohen, Lei Fang, Laura J Szewczyk, PhD Timothy P Sheahan, Ralph Baric, MS Katie R Mollan, MBBS MPH Cameron R Wolfe, MD Elizabeth R Duke, MD Masoud M Azizad, Katyna Borroto-Esoda, MD David A Wohl, BSc Amy James Loftis, BSc Paul Alabanza, Felicia Lipansky, MD, MPH Wendy P Painter
doi:10.1101/2021.06.17.21258639
Background: Easily distributed oral antivirals are urgently needed to treat coronavirus disease-2019 (COVID-19), prevent progression to severe illness, and block transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We report the results of a All rights reserved. No reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
Change from Baseline in SARS-CoV-2 Viral Load The decrease in viral RNA from baseline to Days 3 to 28 was greater for the 800 mg molnupiravir group than any other group (Table 2 and Figure 2c ). For participants administered 400 or 800 mg molnupiravir, the least squares mean viral load change from baseline was significantly greater on Day 5 when compared to placebo, with differences in least squares means of -0.434 and -0.547 log 10 copies/mL (p = 0.03 and 0.006), respectively. Additionally, for participants administered 800 mg molnupiravir, the least squares mean viral load change from baseline was also significantly greater on Day 7 compared to placebo, with a least squares mean difference of -0.534 log 10 copies/mL (p = 0.006). The reduction in viral load from baseline to Day 5 between 800 mg molnupiravir and placebo remained significant during sensitivity analyses of participants who were negative for antibodies at baseline (least squares mean difference of -0.613 log 10 copies/mL; p = 0.002; Supplementary Table 6 ) and when compared to concurrent placebo (least squares mean difference of -0.376 log 10 copies/mL; p = 0.045; Supplementary Table 8 ). SARS-CoV-2 Antibody Detection Participants were tested for SARS-CoV-2-specific immunoglobulin (Ig) A, IgM, and IgG at baseline and on Days 7 and 28. The proportions of participants with any antibody to SARS-CoV-2 at baseline varied between the groups, with 15.0%, 30.0%, 35.3%, and 18.2% in the 200, 400, 800 mg..
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We report the results of a Phase 2a trial evaluating the ' 'safety, tolerability, and antiviral efficacy of molnupiravir in the treatment of COVID-19 ' '(<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" ' 'xlink:href="http://ClinicalTrials.gov">ClinicalTrials.gov</jats:ext-link><jats:ext-link ' 'xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" ' 'xlink:href="NCT04405570">NCT04405570</jats:ext-link>).</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Eligible ' 'participants included outpatients with confirmed SARS-CoV-2 infection and symptom onset ' 'within 7 days. Participants were randomized 1:1 to 200 mg molnupiravir or placebo, or 3:1 to ' 'molnupiravir (400 or 800 mg) or placebo, twice-daily for 5 days. Antiviral activity was ' 'assessed as time to undetectable levels of viral RNA by reverse transcriptase polymerase ' 'chain reaction and time to elimination of infectious virus isolation from nasopharyngeal ' 'swabs.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Among 202 treated ' 'participants, virus isolation was significantly lower in participants receiving 800 mg ' 'molnupiravir (1.9%) versus placebo (16.7%) at Day 3 (p = 0.02). At Day 5, virus was not ' 'isolated from any participants receiving 400 or 800 mg molnupiravir, versus 11.1% of those ' 'receiving placebo (p = 0.03). Time to viral RNA clearance was decreased and a greater ' 'proportion overall achieved clearance in participants administered 800 mg molnupiravir versus ' 'placebo (p = 0.01). Molnupiravir was generally well tolerated, with similar numbers of ' 'adverse events across all ' 'groups.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>Molnupiravir ' 'is the first oral, direct-acting antiviral shown to be highly effective at reducing ' 'nasopharyngeal SARS-CoV-2 infectious virus and viral RNA and has a favorable safety and ' 'tolerability profile.</jats:p></jats:sec>', 'accepted': {'date-parts': [[2021, 6, 17]]}, 'author': [ {'affiliation': [], 'family': 'Fischer', 'given': 'William', 'sequence': 'first'}, { 'affiliation': [], 'family': 'Eron', 'given': 'Joseph J.', 'sequence': 'additional', 'suffix': 'Jr'}, {'affiliation': [], 'family': 'Holman', 'given': 'Wayne', 'sequence': 'additional'}, {'affiliation': [], 'family': 'Cohen', 'given': 'Myron S.', 'sequence': 'additional'}, {'affiliation': [], 'family': 'Fang', 'given': 'Lei', 'sequence': 'additional'}, {'affiliation': [], 'family': 'Szewczyk', 'given': 'Laura J.', 'sequence': 'additional'}, {'affiliation': [], 'family': 'Sheahan', 'given': 'Timothy P', 'sequence': 'additional'}, {'affiliation': [], 'family': 'Baric', 'given': 'Ralph', 'sequence': 'additional'}, {'affiliation': [], 'family': 'Mollan', 'given': 'Katie R.', 'sequence': 'additional'}, {'affiliation': [], 'family': 'Wolfe', 'given': 'Cameron R.', 'sequence': 'additional'}, {'affiliation': [], 'family': 'Duke', 'given': 'Elizabeth R.', 'sequence': 'additional'}, {'affiliation': [], 'family': 'Azizad', 'given': 'Masoud M.', 'sequence': 'additional'}, {'affiliation': [], 'family': 'Borroto-Esoda', 'given': 'Katyna', 'sequence': 'additional'}, {'affiliation': [], 'family': 'Wohl', 'given': 'David A.', 'sequence': 'additional'}, {'affiliation': [], 'family': 'Loftis', 'given': 'Amy James', 'sequence': 'additional'}, {'affiliation': [], 'family': 'Alabanza', 'given': 'Paul', 'sequence': 'additional'}, {'affiliation': [], 'family': 'Lipansky', 'given': 'Felicia', 'sequence': 'additional'}, {'affiliation': [], 'family': 'Painter', 'given': 'Wendy P.', 'sequence': 'additional'}], 'container-title': [], 'content-domain': {'crossmark-restriction': False, 'domain': []}, 'created': {'date-parts': [[2021, 6, 18]], 'date-time': '2021-06-18T05:30:17Z', 'timestamp': 1623994217000}, 'deposited': { 'date-parts': [[2022, 12, 31]], 'date-time': '2022-12-31T15:29:53Z', 'timestamp': 1672500593000}, 'group-title': 'Infectious Diseases (except HIV/AIDS)', 'indexed': {'date-parts': [[2024, 3, 26]], 'date-time': '2024-03-26T23:10:51Z', 'timestamp': 1711494651280}, 'institution': [{'name': 'medRxiv'}], 'is-referenced-by-count': 122, 'issued': {'date-parts': [[2021, 6, 17]]}, 'link': [ { 'URL': 'https://syndication.highwire.org/content/doi/10.1101/2021.06.17.21258639', 'content-type': 'unspecified', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'member': '246', 'original-title': [], 'posted': {'date-parts': [[2021, 6, 17]]}, 'prefix': '10.1101', 'published': {'date-parts': [[2021, 6, 17]]}, 'publisher': 'Cold Spring Harbor Laboratory', 'reference': [ { 'key': '2021061908100663000_2021.06.17.21258639v1.1', 'unstructured': 'World Health Organisation. Weekly epidemiological update on COVID-19 - ' '25 May 2021 [Internet]. Coronavirus Dis. COVID-19 Pandemic. 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