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Summary of COVID-19 molnupiravir studies

Studies   Meta Analysis   Hide extended summaries

592 patient molnupiravir early treatment RCT: 103% worse viral clearance (p=0.33).
PANORAMIC virology-sub-study showing increased viral persistence with molnupiravir treatment. Molnupiravir 800mg twice daily for 5 days led to faster initial viral decline but 86% still had detectable virus by day 5. By day 14, molnupiravir was associated with significantly higher proportions with detectable virus and lower anti-spike antibodies compared to usual care. Serial genome sequencing revealed substantially increased mutagenesis with molnupiravir. Viable virus was cultured from samples up to 9 days post-treatment.

Feb 2024, Nature Communications, https://www.nature.com/articles/s41467-024-45641-0, https://c19p.org/standing

25 patient molnupiravir early treatment RCT: 83% worse recovery (p=0.36).
Very small early terminated RCT with 8 molnupiravir and 17 placebo patients showing worse recovery with molnupiravir, without statistical significance.

Nov 2023, BJGP Open, http://bjgpopen.org/lookup/doi/10.3399/BJGPO.2023.0109, https://c19p.org/tare

291 patient molnupiravir late treatment RCT: 282% higher mortality (p=0.31), 1% improved recovery (p=0.96), and 12% improved viral clearance (p=0.57).
RCT 304 hospitalized patients, 218 treated with molnupiravir, showing no significant differences. MOVe-IN MK-4482-001. NCT04575584.

Dec 2021, NEJM Evidence, https://evidence.nejm.org/pb-assets/evidence-site/content/EVIDoa2100044.pdf, https://c19p.org/arribas

18 patient molnupiravir early treatment RCT: 33% worse recovery (p=0.63).
Dose and safety study of molnupiravir with 18 participants, finding no serious adverse events in short-term followup. There was no significant difference in clinical outcomes. NCT04746183.

Aug 2021, J. Antimicrobial Chemotherapy, https://academic.oup.com/jac/advance-article/doi/10.1093/jac/dkab318/6358705, https://c19p.org/khoo

78 patient molnupiravir late treatment study: 50% higher mortality (p=1) and no change in ICU admission (p=1).
Retrospective study of 78 hospitalized COVID-19 patients in Turkey showing no significant difference in mortality or discharge rates with molnupiravir treatment.

Mar 2024, Celal Bayar Üniversitesi Sağlık Bilimleri Enstitüsü Dergisi, http://dergipark.org.tr/tr/doi/10.34087/cbusbed.1423523, https://c19p.org/ozdemir

923 patient molnupiravir late treatment RCT: 11% higher mortality (p=0.55), 43% higher ventilation (p=0.59), 9% lower hospital discharge (p=0.46), and 12% improved viral clearance (p<0.0001).
RECOVERY RCT showing no significant differences in mortality, ventilation, or discharge with either molnupiravir (923 patients) or paxlovid (137 patients). Viral load was improved with treatment but did not translate into clinical benefit, which may in part be due to side effects of treatment. The treatment delay was notably shorter compared to other treatments in this trial - 4 and 5 days from onset for paxlovid and molnupiravir. There was an exactly one year delay in publication after completion of recruitment. No press release or results are shown on the trial web site. In contrast, a press release was issued for the HCQ arm on the same day that recruitment ended. The one year delay may be a maximum delay due to EU Clinical Trials registration and associated regulatory requirements for the release of results within 12 months.

May 2024, medRxiv, https://www.medrxiv.org/content/10.1101/2024.05.23.24307731v1, https://c19p.org/horby

42 patient molnupiravir early treatment study: 18% shorter hospitalization (p=0.14) and 21% faster viral clearance (p=0.1).
Retrospective 42 elderly patients in China showing faster viral clearance with molnupiravir.

Oct 2022, Infectious Diseases and Therapy, https://link.springer.com/10.1007/s40121-022-00716-7, https://c19p.org/liu5

416 patient molnupiravir early treatment study: 110% higher mortality (p=0.47) and 58% lower hospitalization (p=0.7).
Retrospective 604 outpatients in the UK, showing lower risk of hospitalization with molnupiravir treatment, without statistical significance due to the small number of hospitalizations.

Mar 2023, PLOS ONE, https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0281915, https://c19p.org/goodwinm

88,962 patient molnupiravir early treatment study: 12% higher combined mortality/ICU admission (p=0.66) and 17% higher hospitalization (p=0.06).
Propensity score weighted retrospective of 93,883 outpatients in Hong Kong, 5,808 treated with molnupiravir and 4,921 treated with paxlovid, showing higher hospitalization and higher combined mortality/mechanical ventilation/ICU admission with molnupiravir, without statistical significance; and lower hospitalization and combined mortality/mechanical ventilation/ICU admission with paxlovid, statistically significant only for hospitalization.

May 2022, Clinical Infectious Diseases, https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciac687/6678124, https://c19p.org/yip

6,020 patient molnupiravir early treatment study: 100% higher combined mortality/hospitalization (p=0.005).
Retrospective 3,331 sotrovimab and 2,689 molnupiravir patients in the UK, showing higher risk of combined hospitalization/death with molnupiravir.

Nov 2022, BMJ, https://www.bmj.com/lookup/doi/10.1136/bmj-2022-071932, https://c19p.org/zheng4

664 patient molnupiravir early treatment study: 101% higher hospitalization (p=0.51).
Retrospective 442 patients in the UK treated with molnupiravir, and 222 eligible but declining treatment, showing no significant difference in hospitalization. No group details are provided and the results are subject to confounding by indication.

Oct 2022, Open Forum Infectious Diseases, https://academic.oup.com/ofid/advance-article/doi/10.1093/ofid/ofac527/6750023, https://c19p.org/brown2

65,010 patient molnupiravir early treatment study: 9% higher combined mortality/hospitalization (p=0.75).
Retrospective 65,010 veterans in the USA, showing no significant difference in hospitalization/death with molnupiravir treatment. 1,729 patients received molnupiravir. Authors emulate a target trial closely matching the MOVe-OUT RCT and using 1,459 matched pairs.

May 2023, The J. Infectious Diseases, https://academic.oup.com/jid/advance-article/doi/10.1093/infdis/jiad195/7187858, https://c19p.org/butt

218 patient molnupiravir early treatment study: 15% higher severe cases (p=0.71).
Retrospective 218 COVID+ lung transplant patients in Germany, showing no significant difference in severe cases with early molnupiravir use.

Sep 2022, Infection, https://link.springer.com/10.1007/s15010-022-01914-8, https://c19p.org/kneidinger

68,640 patient molnupiravir early treatment study: 9% higher combined mortality/hospitalization (p=0.28).
OpenSAFELY retrospective 75,048 outpatients in the UK, using the clone-censor-weight approach to address immortal time bias, showing no significant difference in combined mortality/hospitalization with molnupiravir treatment.

May 2023, medRxiv, https://www.medrxiv.org/content/10.1101/2023.05.12.23289914, https://c19p.org/tazare

5,638 patient molnupiravir early treatment study: 285% higher combined mortality/hospitalization (p=0.004).
OpenSAFELY retrospective 5,638 outpatients in the UK, showing significantly higher hospitalization/death for molnupiravir compared with paxlovid.

Jan 2023, medRxiv, https://www.medrxiv.org/content/10.1101/2023.01.20.23284849, https://c19p.org/zheng5m

294 patient molnupiravir early treatment study: 127% higher combined mortality/hospitalization (p=0.22) and 127% higher hospitalization (p=0.22).
Retrospective 294 consecutive patients in Japan, showing higher risk of hospitalization/death with molnupiravir, without statistical significance.

Jan 2023, Research Square, https://www.researchsquare.com/article/rs-2451986/v1, https://c19p.org/inaba

920 patient molnupiravir early treatment PSM study: 53% lower progression (p=0.04).
Retrospective 1,921 patients in Japan, showing lower progression with molnupiravir use.

Oct 2022, Clinical and Experimental Medicine, https://link.springer.com/10.1007/s10238-022-00949-3, https://c19p.org/suzuki2

1,794 patient molnupiravir early treatment PSM study: 18% lower mortality (p=0.4), 1% lower ICU admission (p=1), and 30% higher hospitalization (p=0.04).
Retrospective 112,380 high-risk patients in the USA, showing significantly higher acute or long-term care admission at 180 days with molnupiravir treatment, and no significant difference for other outcomes. The title and headers of Table S14 are conflicting but the data appears to match be title.

Dec 2022, medRxiv, https://www.medrxiv.org/content/10.1101/2022.12.05.22283134, https://c19p.org/bajemam

261,706 patient molnupiravir long COVID study: 4% lower PASC (p=0.001).
Retrospective 8,089 molnupiravir patients in the USA showing a small reduction in long COVID with treatment. Confounding is likely significant as below, and may eliminate the benefit. Results specific to the COVID-19 code should be closer to the actual efficacy due to likely lower average severity of the additional treatment patients included based on home tests.

Oct 2023, JAMA Internal Medicine, https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2811092, https://c19p.org/fung2

molnupiravir late treatment RCT: no change in recovery (p=1).
Trial CTRI/2021/08/035424 for moderate condition patients has been reported as terminated for futility. Results are not available yet [trialsearch.who.int].

Oct 2021, Reuters, https://www.reuters.com/business/healthcare-pharmaceuticals/aurobindo-pharma-stop-molnupiravir-trial-moderate-covid-19-patients-2021-10-08/, https://c19p.org/mp5424

molnupiravir late treatment RCT: no change in recovery (p=1).
Trial CTRI/2021/05/033864 for moderate condition patients has been reported as terminated for futility. Results are not available yet [trialsearch.who.int].

Oct 2021, Reuters, https://www.reuters.com/business/healthcare-pharmaceuticals/aurobindo-pharma-stop-molnupiravir-trial-moderate-covid-19-patients-2021-10-08/, https://c19p.org/mp3864

16,495 patient molnupiravir late treatment study: 13% lower mortality (p<0.0001), 7% higher ventilation (p=0.49), and 2% higher ICU admission (p=0.9).
Target trial emulation retrospective with 16,495 patients in Hong Kong, showing lower mortality with molnupiravir, but no significant difference for ventilation and ICU admission. See also [acpjournals.org], [acpjournals.org].

Apr 2023, Annals of Internal Medicine, https://www.acpjournals.org/doi/10.7326/M22-3057, https://c19p.org/wan2

5,322 patient molnupiravir early treatment PSM study: 19% lower mortality (p=0.48), 17% lower progression (p=0.34), and 25% lower severe cases (p=0.15).
PSM retrospective 2,661 molnupiravir patients in Israel, showing lower mortality and severe COVID-19, without statistical significance. Significant benefit was seen in some subgroups, and significant harm was seen in the <75 subgroup.

Sep 2022, Clinical Infectious Diseases, https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciac781/6708264, https://c19p.org/najjardebbiny2

9,938 patient molnupiravir early treatment study: 15% lower mortality (p=0.003), no change in oxygen therapy (p=1), and 12% lower ICU admission (p=0.52).
Retrospective emulated target trial of hospitalized COVID-19 patients with chronic kidney disease in Hong Kong showing lower mortality with molnupiravir and paxlovid treatment. No significant reduction was found in ICU admission or ventilatory support. Notably, there is no estimated benefit for ventilatory support, the outcome most directly related to severe COVID-19. The very large difference in vaccine uptake suggests major confounding issues, for example treatment decisions based on vaccine uptake, or confounding by time where control patients are more likely from earlier periods with lower vaccine uptake, which may also correspond to more dangerous variants.

Feb 2024, Kidney Int. Reports, https://www.sciencedirect.com/science/article/pii/S2468024924000986, https://c19p.org/cheng4

23,436 patient molnupiravir late treatment study: 11% lower mortality (p=0.02), 1% lower hospitalization (p=0.76), and 4% higher progression (p=0.18).
Retrospective 30,040 hospitalized patients in Hong Kong, showing lower mortality with molnupiravir treatment.

Feb 2023, J. Infection, https://www.sciencedirect.com/science/article/pii/S0163445323001172, https://c19p.org/wanm

590 patient molnupiravir early treatment study: 39% lower mortality (p=0.03), 5% lower ventilation (p=1), and 1% longer hospitalization (p=0.97).
Retrospective 590 patients in Poland, 203 treated with mulnupiravir, showing lower mortality with treatment.

Jul 2022, Pharmacological Reports, https://link.springer.com/10.1007/s43440-022-00408-6, https://c19p.org/flisiak2

1,527 patient molnupiravir prophylaxis RCT: 24% fewer symptomatic cases (p=0.06).
PEP RCT 1,527 patients showing lower COVID-19 cases with molnupiravir, without statistical significance.

Sep 2023, J. Infection, https://www.journalofinfection.com/article/S0163-4453(23)00500-5/fulltext, https://c19p.org/alpizar

25,054 patient molnupiravir early treatment RCT: 6% higher combined mortality/hospitalization (p=0.69), 7% higher hospitalization (p=0.67), 2% lower transmission (p=0.88), and 22% improved recovery (p<0.0001).
26,411 patient RCT in the UK, showing faster recovery but no significant difference in hospitalization/death or transmission. Improved recovery may be in part due to the open label design with self-reported symptomatic data. Viral load initially declined more quickly, but was higher at 14 days.

Oct 2022, The Lancet, https://www.sciencedirect.com/science/article/pii/S0140673622025971, https://c19p.org/butler2

202 patient molnupiravir early treatment RCT: 77% lower mortality (p=0.31) and 49% improved viral clearance (p=0.12).
RCT 202 outpatients in the USA showing significantly faster viral clearance, but no significant differences in symptom duration or severity. NCT04405570.

Jun 2021, medRxiv, https://www.medrxiv.org/content/10.1101/2021.06.17.21258639v1, https://c19p.org/fischer

5,332 patient molnupiravir early treatment study: 51% lower combined mortality/hospitalization (p=0.008).
Retrospective high risk outpatients in the UK, showing lower hospitalization/death with molnupiravir treatment. Residual confounding is likely with adjustments having no detail on specific comorbidities.

Jan 2023, J. Infection, https://www.sciencedirect.com/science/article/pii/S0163445323000828, https://c19p.org/evans2m

19,868 patient molnupiravir early treatment study: 74% lower mortality (p=0.008) and 45% lower hospitalization (p=0.01).
Retrospective 19,868 patients eligible for molnupiravir treatment in Israel with 1,069 treated, showing lower mortality and hospitalization with treatment for the subgroup of patients ≥65, and higher mortality for patients 40-64. Authors only provide subgroup results.

Sep 2022, New England J. Medicine, https://www.nejm.org/doi/full/10.1056/NEJMoa2204919, https://c19p.org/arbel3

108 patient molnupiravir early treatment RCT: 29% faster recovery (p=0.5) and 10% faster viral clearance (p=0.009).
RCT 116 mild/moderate COVID-19 patients in China, showing improved viral clearance with treatment.

Jun 2022, Frontiers in Pharmacology, https://www.frontiersin.org/articles/10.3389/fphar.2022.939573/full, https://c19p.org/zou

54,217 patient molnupiravir early treatment PSM study: 24% lower mortality (p=0.01), 60% lower ventilation (p=0.02), 26% lower ICU admission (p=0.24), and 2% lower hospitalization (p=0.58).
PSM retrospective 1,074,856 outpatients in Hong Kong, showing lower mortality with molnupiravir.

Oct 2022, The Lancet, https://www.sciencedirect.com/science/article/pii/S0140673622015860, https://c19p.org/wong5m

3,712 patient molnupiravir early treatment PSM study: 52% lower mortality (p<0.0001), 58% lower ventilation (p=0.06), 40% lower progression (p<0.0001), and 6% shorter hospitalization (p=0.03).
PSM retrospective 40,776 patients in Hong Kong, showing lower mortality and lower combined mortality, ventilation, ICU, and oxygen therapy with molnupiravir treatment.

May 2022, The Lancet Infectious Diseases, https://www.sciencedirect.com/science/article/pii/S1473309922005072, https://c19p.org/wong3

180 patient molnupiravir early treatment RCT: 89% lower hospitalization (p=0.12), 12% worse recovery (p=0.74), and 23% improved viral clearance (p=0.07).
RCT 90 molnupiravir and 90 placebo patients, showing faster viral clearance with treatment, not reaching the pre-defined threshold for superiority and recommendation as a candidate for large scale evaluation.

Jul 2022, The Lancet Infectious Diseases, https://www.sciencedirect.com/science/article/pii/S1473309922006442, https://c19p.org/khoo2

355 patient molnupiravir early treatment RCT: 58% improved viral clearance (p<0.0001).
Interim report on CTRI/2021/06/033992, showing faster viral clearance. Event counts are approximate, the press release only provides percentages.

Jul 2021, Optimus, Press Release, https://theprint.in/ani-press-releases/optimus-announces-interim-clinical-results-from-phase-iii-clinical-trials-of-molnupiravir-conducted-in-india/699993/, https://c19p.org/optimus

1,220 patient molnupiravir early treatment RCT: 46% lower hospitalization (p=0.26), 46% greater improvement (p<0.0001), and 59% improved viral clearance (p<0.0001).
RCT 1,220 patients in India, showing lower risk of hospitalization and improved recovery with treatment. CTRI/2021/07/034588.

Feb 2022, SSRN Electronic J., https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4042673, https://c19p.org/tippabhotla

1,408 patient molnupiravir early treatment RCT: 89% lower mortality (p=0.01), 30% lower combined mortality/hospitalization (p=0.05), 15% faster recovery (p=0.02), and 4% improved viral clearance (p=0.2).
MOVe-OUT RCT, showing significantly lower risk of hospitalization or death. In subgroup analysis efficacy was much lower with the delta variant. See also [Guan, Strizki]. Discussion of concerns with this trial can be found at [defyccc.com, trialsitenews.com]. See also: [twitter.com, twitter.com].

Dec 2021, New England J. Medicine, http://www.nejm.org/doi/pdf/10.1056/NEJMoa2116044, https://c19p.org/jaykbernal

741 patient molnupiravir early treatment RCT: 70% lower hospitalization (p=0.003) and 33% faster recovery (p=0.0001).
Interim results for CTRI/2021/05/033739, showing lower mortality and faster recovery.

Jul 2021, Hetero, Press Release, https://www.heteroworld.com/images/Press_Release_Molnupiravir_Interim_Clinical_Results_Final_090721.pdf, https://c19p.org/hetero

1,218 patient molnupiravir early treatment RCT: 65% lower hospitalization (p=0.005), 53% greater improvement (p=0.01), and 48% improved viral clearance (p<0.0001).
RCT 1,218 outpatients in India, showing lower hospitalization, better clinical improvement, and improved viral clearance with molnupiravir.

Nov 2022, Cureus, https://www.cureus.com/articles/118243-efficacy-and-safety-of-molnupiravir-in-mild-covid-19-patients-in-india, https://c19p.org/sinha
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