tetano
Editor, Senior Moderator
Clin Infect Dis
. 2023 Jun 19;ciad409.
doi: 10.1093/cid/ciad409. Online ahead of print. Impact of Molnupiravir Treatment on Patient-Reported Coronavirus Disease 2019 (COVID-19) Symptoms in the Phase 3 MOVe-OUT Trial: A Randomized, Placebo-Controlled Trial
Yanfen Guan[SUP] 1 [/SUP], Amy Puenpatom[SUP] 1 [/SUP], Matthew G Johnson[SUP] 1 [/SUP], Ying Zhang[SUP] 1 [/SUP], Yujie Zhao[SUP] 1 [/SUP], Joseph Surber[SUP] 2 [/SUP], Aaron Weinberg[SUP] 3 [/SUP], Carlos Brotons[SUP] 4 [/SUP], Roman Kozlov[SUP] 5 [/SUP], Rudy Lopez[SUP] 6 [/SUP], Kathleen Coetzee[SUP] 7 [/SUP], Joel Santiaguel[SUP] 8 [/SUP], Jiejun Du[SUP] 1 [/SUP], Angela Williams-Diaz[SUP] 1 [/SUP], Michelle Brown[SUP] 1 [/SUP], Amanda Paschke[SUP] 1 [/SUP], Carisa De Anda[SUP] 1 [/SUP], Josephine M Norquist[SUP] 1 [/SUP]
Affiliations
Background: Molnupiravir is an orally administered antiviral authorized for COVID-19 treatment in adults at high risk of progression to severe disease. Here, we report secondary and post hoc analyses of participants' self-reported symptoms in the MOVe-OUT trial, which evaluated molnupiravir initiated within 5 days of symptom onset in nonhospitalized, unvaccinated adults with mild-to-moderate, laboratory-confirmed COVID-19.
Methods: Eligible participants completed a 15-item symptom diary daily from day 1 (randomization) through day 29, rating symptom severity as "none," "mild," "moderate," or "severe"; loss of smell and loss of taste were rated as "yes" or "no." Time to sustained symptom resolution/improvement was defined as the number of days from randomization to the first of 3 consecutive days of reduced severity, without subsequent relapse. Time to symptom progression was defined as the number of days from randomization to the first of 2 consecutive days of worsening severity. The Kaplan-Meier method was used to estimate event rates at various time points. The Cox proportional hazards model was used to estimate the hazard ratio between molnupiravir and placebo.
Results: For most targeted COVID-19 symptoms, sustained resolution/improvement was more likely, and progression was less likely, in the molnupiravir versus placebo group through day 29. When evaluating 5 distinctive symptoms of COVID-19, molnupiravir participants had a shorter median time to first resolution (18 vs 20 d) and first alleviation (13 vs 15 d) of symptoms compared with placebo.
Conclusions: Molnupiravir treatment in at-risk, unvaccinated patients resulted in improved clinical outcomes for most participant-reported COVID-19 symptoms compared with placebo. Clinical Trials Registration. ClinicalTrials.gov: NCT04575597.
Keywords: SARS-CoV-2; antiviral; clinical trial; public health; β-D-N4-hydroxycytidine.
. 2023 Jun 19;ciad409.
doi: 10.1093/cid/ciad409. Online ahead of print. Impact of Molnupiravir Treatment on Patient-Reported Coronavirus Disease 2019 (COVID-19) Symptoms in the Phase 3 MOVe-OUT Trial: A Randomized, Placebo-Controlled Trial
Yanfen Guan[SUP] 1 [/SUP], Amy Puenpatom[SUP] 1 [/SUP], Matthew G Johnson[SUP] 1 [/SUP], Ying Zhang[SUP] 1 [/SUP], Yujie Zhao[SUP] 1 [/SUP], Joseph Surber[SUP] 2 [/SUP], Aaron Weinberg[SUP] 3 [/SUP], Carlos Brotons[SUP] 4 [/SUP], Roman Kozlov[SUP] 5 [/SUP], Rudy Lopez[SUP] 6 [/SUP], Kathleen Coetzee[SUP] 7 [/SUP], Joel Santiaguel[SUP] 8 [/SUP], Jiejun Du[SUP] 1 [/SUP], Angela Williams-Diaz[SUP] 1 [/SUP], Michelle Brown[SUP] 1 [/SUP], Amanda Paschke[SUP] 1 [/SUP], Carisa De Anda[SUP] 1 [/SUP], Josephine M Norquist[SUP] 1 [/SUP]
Affiliations
- PMID: 37466374
- DOI: 10.1093/cid/ciad409
Background: Molnupiravir is an orally administered antiviral authorized for COVID-19 treatment in adults at high risk of progression to severe disease. Here, we report secondary and post hoc analyses of participants' self-reported symptoms in the MOVe-OUT trial, which evaluated molnupiravir initiated within 5 days of symptom onset in nonhospitalized, unvaccinated adults with mild-to-moderate, laboratory-confirmed COVID-19.
Methods: Eligible participants completed a 15-item symptom diary daily from day 1 (randomization) through day 29, rating symptom severity as "none," "mild," "moderate," or "severe"; loss of smell and loss of taste were rated as "yes" or "no." Time to sustained symptom resolution/improvement was defined as the number of days from randomization to the first of 3 consecutive days of reduced severity, without subsequent relapse. Time to symptom progression was defined as the number of days from randomization to the first of 2 consecutive days of worsening severity. The Kaplan-Meier method was used to estimate event rates at various time points. The Cox proportional hazards model was used to estimate the hazard ratio between molnupiravir and placebo.
Results: For most targeted COVID-19 symptoms, sustained resolution/improvement was more likely, and progression was less likely, in the molnupiravir versus placebo group through day 29. When evaluating 5 distinctive symptoms of COVID-19, molnupiravir participants had a shorter median time to first resolution (18 vs 20 d) and first alleviation (13 vs 15 d) of symptoms compared with placebo.
Conclusions: Molnupiravir treatment in at-risk, unvaccinated patients resulted in improved clinical outcomes for most participant-reported COVID-19 symptoms compared with placebo. Clinical Trials Registration. ClinicalTrials.gov: NCT04575597.
Keywords: SARS-CoV-2; antiviral; clinical trial; public health; β-D-N4-hydroxycytidine.