Evidence map›Paper›PMID 41532840›Full record

Trial reportJournal of medical virology2026

Oral Melatonin in Critically Ill Patients With COVID-19: A Quasi-Experimental Pragmatic Trial.

Miguel Sánchez-García, Jesús A F Tresguerres, Manuel Álvarez-González, Belén de la Hera, Virginia Puebla, Lidia Ybañez, José-Manuel Martínez-Sesmero, Antonio Blesa, Juan-Carlos Martín-Benítez, Fernando Martínez-Sagasti and 13 more

Abstract readPragmatic Clinical Trial
In one paragraph

Trial report in Journal of medical virology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Review
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

23 authors.

Miguel Sánchez-GarcíaDepartment of Critical Care, Hospital Clínico San Carlos, Madrid, Spain.ORCID https://orcid.org/0000-0002-8775-255X
Jesús A F TresguerresDepartment of Medicine, Medical School, Universidad Complutense Madrid, Madrid, Spain.
Manuel Álvarez-GonzálezDepartment of Critical Care, Hospital Clínico San Carlos, Madrid, Spain.
Belén de la HeraDepartment of Critical Care, Hospital Clínico San Carlos, Madrid, Spain.
Virginia PueblaPharmacy Service, Hospital Clínico San Carlos, Madrid, Spain.
Lidia YbañezPharmacy Service, Hospital Clínico San Carlos, Madrid, Spain.
José-Manuel Martínez-SesmeroPharmacy Service, Hospital Clínico San Carlos, Madrid, Spain.
Antonio BlesaDepartment of Critical Care, Hospital Clínico San Carlos, Madrid, Spain.
Juan-Carlos Martín-BenítezDepartment of Critical Care, Hospital Clínico San Carlos, Madrid, Spain.
Fernando Martínez-SagastiDepartment of Critical Care, Hospital Clínico San Carlos, Madrid, Spain.
Paloma González-ArenasDepartment of Critical Care, Hospital Clínico San Carlos, Madrid, Spain.
Sara DomingoDepartment of Critical Care, Hospital Clínico San Carlos, Madrid, Spain.
Cándido PardoDepartment of Critical Care, Hospital Clínico San Carlos, Madrid, Spain.
Silmary MaichleDepartment of Critical Care, Hospital Clínico San Carlos, Madrid, Spain.
Carolina PostigoDepartment of Critical Care, Hospital Clínico San Carlos, Madrid, Spain.
Sara De-MiguelDepartment of Critical Care, Hospital Clínico San Carlos, Madrid, Spain.
María BringasDepartment of Critical Care, Hospital Clínico San Carlos, Madrid, Spain.
Raquel González-CasanovaDepartment of Critical Care, Hospital Clínico San Carlos, Madrid, Spain.
Viktor YordanovDepartment of Critical Care, Hospital Clínico San Carlos, Madrid, Spain.
Alberto Delgado-IribarrenMicrobiology Service, Hospital Clínico San Carlos, Madrid, Spain.
Esther CulebrasMicrobiology Service, Hospital Clínico San Carlos, Madrid, Spain.
Miguel A Armengol-de la-HozDepartment of Big Data, PMC-FPS, Regional Ministry of Health and Consumer Affairs, Sevilla, Andalucia, Spain.
Antonio Núñez-ReizDepartment of Critical Care, Hospital Clínico San Carlos, Madrid, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Melatonin has demonstrated antioxidant, anti-inflammatory, and potential antiviral properties. Its therapeutic role in critically ill COVID-19 patients admitted to intensive care was underexplored at the start of the pandemic. We conducted a quasi-experimental, pragmatic study over 4 consecutive uninterrupted time periods alternating control groups receiving standard of care (SoC) with treatment groups receiving SoC plus high-dose oral bedtime melatonin (50-200 mg) (OBM). The primary endpoint was 90-day mortality; secondary outcomes included sequential organ failure assessment (SOFA) scores at 4, 7, 14, and 30 days and pre-defined severe adverse events (SAEs). A total of 335 of 339 consecutive patients with a predicted stay > 48 h were enrolled; 202 received OBM with SoC and 133 received SoC alone. OBM was dispensed during the second (n = 162) and fourth (n = 40) study periods after the first (n = 40) and third (n = 93) control group periods, respectively. Melatonin therapy was associated with significantly lower 90-day mortality (20.8% vs. 36.1%, OR 0.46, 95% CI 0.28-0.76). Subjects receiving melatonin had lower SOFA scores on Day 4 and subsequent study visits. SAEs occurred in 84 (41.6%) subjects on OBM and in 80 (60.2%) receiving SoC (risk ratio 0.68, 95% CI 0.54-0.87; p = 0.001). High-dose oral melatonin was safe and associated with improved clinical outcomes. Further evaluation of melatonin and its potential antiviral effects in future epidemics is warranted.

Indexed as

AntioxidantsCOVID-19 Drug TreatmentMelatoninAdministration, OralAdultAgedAntiviral AgentsCOVID-19Critical IllnessFemaleHumansIntensive Care UnitsMaleMiddle AgedOrgan Dysfunction ScoresSARS-CoV-2AntioxidantsAntiviral AgentsMelatoninacute respiratory distress syndromeantiviral effectsCOVID‐19ICUmortalityOral melatoninSARS‐CoV‐2

Identifiers

PMID41532840
PMCPMC12802531

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

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 OpenQuestion graph.