Molnupiravir Therapy in Non-hospitalized Patients with COVID-19
The New England Journal of Medicine
Molnupiravir is an orally
administered form of a potent ribonucleoside analog that inhibits the
replication of SARS-CoV-2. For nonhospitalized, unvaccinated adults with
mild-to-moderate COVID-19 and at least one risk factor for severe disease,
molnupiravir reduces the risk for hospitalization or death, according to a
study published Dec. 16 in the New England Journal of Medicine.
This study looked at using
molnupiravir to prevent hospitalizations for outpatients. The total number of
patients in the study was 1433 with 716 in the molnupiravir arm and 717 in the
placebo arm.
The primary outcome of
hospitalization or death by day 29 was reduced by 30% in the molnupiravir group
compared to the placebo group.
The U.S. Food and Drug
Administration issued an emergency use authorization (EUA) for molnupiravir for
the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with
positive results of direct SARS-CoV-2 viral testing, and who are at high risk
for progression to severe COVID-19, including hospitalization or death.
TAKE-HOME MESSAGE
- This phase III, double-blind, randomized,
placebo-controlled trial shows that starting oral treatment with
molnupiravir within 5 days of onset of signs/symptoms of COVID-19 was
associated with reduced risk of hospitalization or death in at-risk,
unvaccinated adults.
-
- Molnupiravir is an effective treatment for the
prevention of adverse outcomes in patients with COVID-19 among those who
are at-risk and unvaccinated.
- This phase III, double-blind, randomized,
placebo-controlled trial shows that starting oral treatment with
molnupiravir within 5 days of onset of signs/symptoms of COVID-19 was
associated with reduced risk of hospitalization or death in at-risk,
unvaccinated adults.
Doctors Liked to Read More
BACKGROUND
New treatments are needed to
reduce the risk of progression of coronavirus disease 2019 (Covid-19).
Molnupiravir is an oral, small-molecule antiviral prodrug that is active
against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
METHODS
Study conducted a phase 3,
double-blind, randomized, placebo-controlled trial to evaluate the efficacy and
safety of treatment with molnupiravir started within 5 days after the onset of
signs or symptoms in nonhospitalized, unvaccinated adults with
mild-to-moderate, laboratory-confirmed Covid-19 and at least one risk factor
for severe Covid-19 illness. Participants in the trial were randomly assigned
to receive 800 mg of molnupiravir or placebo twice daily for 5 days. The
primary efficacy end point was the incidence hospitalization or death at day
29; the incidence of adverse events was the primary safety end point. A planned
interim analysis was performed when 50% of 1550 participants (target
enrollment) had been followed through day 29.
RESULTS
A total of 1433 participants
underwent randomization; 716 were assigned to receive molnupiravir and 717 to
receive placebo. With the exception of an imbalance in sex, baseline
characteristics were similar in the two groups. The superiority of molnupiravir
was demonstrated at the interim analysis; the risk of hospitalization for any
cause or death through day 29 was lower with molnupiravir participants than
with placebo. In the analysis of all participants who had undergone
randomization, the percentage of participants who were hospitalized or died
through day 29 was lower in the molnupiravir group than in the placebo group.
Results of subgroup analyses were largely consistent with these overall
results; in some subgroups, such as patients with evidence of previous
SARS-CoV-2 infection, those with low baseline viral load, and those with
diabetes, the point estimate for the difference favored placebo. One death was
reported in the molnupiravir group and 9 were reported in the placebo group
through day 29. Adverse events were reported in 216 of 710 participants in the
molnupiravir group and 231 of 701 in the placebo group.
CONCLUSIONS
Early treatment with molnupiravir reduced the risk
of hospitalization or death in at-risk, unvaccinated adults with Covid-19.
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