ArticlePharmacological reports : PR2025
Post-marketing surveillance study on the effectiveness and safety of molnupiravir in high-risk COVID-19 outpatients: a prospective case series study.
Article in Pharmacological reports : PR, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMolnupiravir, approved for treating mild to moderate COVID-19 in adults, aims to reduce hospitalisation and mortality rates. Although it was withdrawn from the market after the present study was conducted, understanding its long-term effects remains pertinent. We aimed to assess the real-world effectiveness and safety of molnupiravir in high-risk COVID-19 outpatients.
methodsThis prospective, multicenter, noninterventional, postmarketing cohort study enrolled high-risk COVID-19 outpatients with mild to moderate COVID-19, eligible under national prescribing criteria, who initiated molnupiravir within five days of symptom onset and were ineligible for first-line antiviral therapy. Patients were consecutively enrolled from eight Portuguese study sites and monitored for three months. Effectiveness was assessed by all-cause mortality and hospitalisation through day 29. Safety was evaluated by the incidence, severity, and causality of adverse events (AE), coded using MedDRA terminology and assessed via the WHO-UMC system. Data were collected through structured patient questionnaires and electronic health records. Statistical analysis was descriptive; proportions were reported with 95% confidence intervals (CI), and comparisons between groups were performed using appropriate statistical tests.
resultsBy day 29 post-treatment initiation, no deaths were reported (n = 0; 0%; 95%CI = [0,26]), and all patients were either at home or institutionalised, with favourable outcomes. Out of the 12 patients enrolled, eight (67%; 95%CI = [35,90]) reported at least one AE, with the median time to the first AE being five days (range 5-7 days). Half of the patients (n = 6; 95%CI = [21,79]) reported AE deemed possibly or probably related to molnupiravir, involving nausea (25%), dizziness (17%), bitter taste (17%), and headache (17%). These AE were more commonly observed in older individuals and those overweight, indicating a potential influence of these factors on AE occurrence.
conclusionsMolnupiravir appears to show good safety and effectiveness, offering an alternative for high-risk COVID-19 outpatients ineligible for first-line therapy. Despite its market withdrawal, ongoing research into its long-term effects is crucial to potentially repurpose it for other viral infections.
Indexed as
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.