Molnupiravir for COVID-19: real-time analysis of all 3 studies

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Database of all molnupiravir COVID-19 studies. Submit updates/corrections.


Jun 18	Early	Fischer et al., medRxiv, doi:10.1101/2021.06.17.21258639 (Preprint)	death, ↓76.5%, p=0.31	Molnupiravir, an Oral Antiviral Treatment for COVID-19
	Details RCT 202 outpatients in the USA showing significantly faster viral clearance, but no significant differences in symptom duration or severity. NCT04405570.
Jun 18	Details Source PDF Early treatment study Early treatment study
	Fischer et al., medRxiv, doi:10.1101/2021.06.17.21258639 (Preprint)
	Molnupiravir, an Oral Antiviral Treatment for COVID-19
	RCT 202 outpatients in the USA showing significantly faster viral clearance, but no significant differences in symptom duration or severity. NCT04405570. risk of death, 76.5% lower, RR 0.23, p = 0.31, treatment 0 of 140 (0.0%), control 1 of 62 (1.6%), continuity correction due to zero event, 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%), continuity correction due to zero event, 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%), continuity correction due to zero event, 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%), continuity correction due to zero event, 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%), continuity correction due to zero event, 200mg. risk of no virological cure, 49.2% lower, RR 0.51, p = 0.12, treatment 10 of 118 (8.5%), control 9 of 54 (16.7%), infectious, day 3, all. risk of no virological cure, 88.7% lower, RR 0.11, p = 0.02, treatment 1 of 53 (1.9%), control 9 of 54 (16.7%), infectious, day 3, 800mg. risk of no virological cure, 30.2% lower, RR 0.70, p = 0.57, treatment 5 of 43 (11.6%), control 9 of 54 (16.7%), infectious, day 3, 400mg. risk of no virological cure, 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 virological cure, 92.3% lower, RR 0.08, p = 0.004, treatment 1 of 117 (0.9%), control 6 of 54 (11.1%), infectious, day 5, all. risk of no virological cure, 92.2% lower, RR 0.08, p = 0.03, treatment 0 of 53 (0.0%), control 6 of 54 (11.1%), continuity correction due to zero event, infectious, day 5, 800mg. risk of no virological cure, 91.4% lower, RR 0.09, p = 0.03, treatment 0 of 42 (0.0%), control 6 of 54 (11.1%), continuity correction due to zero event, infectious, day 5, 400mg. risk of no virological cure, 59.1% lower, RR 0.41, p = 0.67, treatment 1 of 22 (4.5%), control 6 of 54 (11.1%), infectious, day 5, 200mg. risk of no virological cure, 29.5% lower, RR 0.70, p = 0.30, treatment 19 of 137 (13.9%), control 12 of 61 (19.7%), all. risk of no virological cure, 61.6% lower, RR 0.38, p = 0.10, treatment 4 of 53 (7.5%), control 12 of 61 (19.7%), 800mg. risk of no virological cure, 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 virological cure, 55.8% lower, RR 0.44, p = 0.33, treatment 2 of 23 (8.7%), control 12 of 61 (19.7%), 200mg. Fischer et al., 6/18/2021, Randomized Controlled Trial, USA, North America, preprint, 18 authors.
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May 7	In Vitro	Zhou et al., The Journal of Infectious Diseases, doi:10.1093/infdis/jiab247 (Peer Reviewed) (In Vitro)	in vitro	β-D-N4-hydroxycytidine Inhibits SARS-CoV-2 Through Lethal Mutagenesis But Is Also Mutagenic To Mammalian Cells
	Details In Vitro study showing that NHC (initial metabolite of molnupiravir) has high antiviral activity against SARS-CoV-2, but also shows host mutational activity in an animal cell culture assay. Authors note the concern that mutations in host ..
May 7	Details Source PDF In Vitro In Vitro
	Zhou et al., The Journal of Infectious Diseases, doi:10.1093/infdis/jiab247 (Peer Reviewed) (In Vitro)
	β-D-N4-hydroxycytidine Inhibits SARS-CoV-2 Through Lethal Mutagenesis But Is Also Mutagenic To Mammalian Cells
	In Vitro study showing that NHC (initial metabolite of molnupiravir) has high antiviral activity against SARS-CoV-2, but also shows host mutational activity in an animal cell culture assay. Authors note the concern that mutations in host DNA could contribute to the development of cancer, or cause birth defects either in a developing fetus or through incorporation into sperm precursor cells. Zhou et al., 5/7/2021, peer-reviewed, 10 authors.
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Apr 15	Late	Merck, News Release (Preprint)		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
	Details News release reporting that the trial of molnupiravir with hospitalized patients (NCT04575584) has been discontinued because data indicates it is unlikely to demonstrate a clinical benefit in hospitalized patients. Results are not availab..
Apr 15	Details Source PDF Late treatment study Late treatment study
	Merck, News Release (Preprint)
	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
	News release reporting that the trial of molnupiravir with hospitalized patients (NCT04575584) has been discontinued because data indicates it is unlikely to demonstrate a clinical benefit in hospitalized patients. Results are not available yet. Interim results for the trial with outpatients show positive dose-dependent results for viral clearance. Merck et al., 4/15/2021, preprint, 1 author.
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