Tweet
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 1 , Amy Puenpatom 1 , Matthew G Johnson 1 , Ying Zhang 1 , Yujie Zhao 1 , Joseph Surber 2 , Aaron Weinberg 3 , Carlos Brotons 4 , Roman Kozlov 5 , Rudy Lopez 6 , Kathleen Coetzee 7 , Joel Santiaguel 8 , Jiejun Du 1 , Angela Williams-Diaz 1 , Michelle Brown 1 , Amanda Paschke 1 , Carisa De Anda 1 , Josephine M Norquist 1
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 1 , Amy Puenpatom 1 , Matthew G Johnson 1 , Ying Zhang 1 , Yujie Zhao 1 , Joseph Surber 2 , Aaron Weinberg 3 , Carlos Brotons 4 , Roman Kozlov 5 , Rudy Lopez 6 , Kathleen Coetzee 7 , Joel Santiaguel 8 , Jiejun Du 1 , Angela Williams-Diaz 1 , Michelle Brown 1 , Amanda Paschke 1 , Carisa De Anda 1 , Josephine M Norquist 1
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.