Evidence map›Paper›PMID 37373625›Full record

ArticleJournal of clinical medicine2023

Estetrol Is Safe and Well Tolerated during Treatment of Hospitalized Men and Women with Moderate COVID-19 in a Randomized, Double-Blind Study.

Jean Michel Foidart, Krzysztof Simon, Wulf H Utian, Franck Mauvais-Jarvis, Jonathan Douxfils, Graham Dixon, Philip Barrington

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Journal of clinical medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04801836 (A Randomized, Double-blind, Placebo-controlled Trial to Determine the Safety and Efficacy of Estetrol), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.6field-weighted citation impact, top 35% of its field
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.

NCT04801836 phase2unknown statusnot on this map

A Randomized, Double-blind, Placebo-controlled Trial to Determine the Safety and Efficacy of Estetrol (E4) for the Treatment of Patients With Confirmed SARS-COV-2 Infection

TypeinterventionalSponsorNEURALIS s.a.Ran2020 to 2022Enrolled162ConditionsCovid19ArmsEstetrol monohydrate 15 mg, Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Article
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

7 authors at 6 institutions in 3 countries.

Jean Michel FoidartMithra Pharmaceuticals, 4000 Liège, Belgium.ORCID 0000-0001-8285-3573
Krzysztof SimonDepartment of Infectious Diseases and Hepatology, Wrocław Medical University, 51149 Wrocław, Poland.
Wulf H UtianDepartment of Reproductive Biology, Case Western Reserve Medical School, Cleveland, OH 44106, USA.
Franck Mauvais-JarvisDepartment of Endocrinology and Metabolism, Tulane University School of Medicine, New Orleans, LA 70112, USA.
Jonathan DouxfilsDepartment of Pharmacy, Namur Thrombosis and Hemostasis Center, Faculty of Medicine, University of Namur, 5000 Namur, Belgium.ORCID 0000-0002-7644-5298
Graham DixonMithra Pharmaceuticals, 4000 Liège, Belgium.
Philip BarringtontranScrip Ltd., Wokingham RG41 5TP, Berkshire, UK.
Case Western Reserve University · USMithra Pharmaceuticals (Belgium) · BETulane University · USUniversity of Liège · BEUniversity of Namur · BEWroclaw Medical University · PL

Funding

Mithra Pharmaceuticals NAWalloon Region of Belgium C8359Walloon Region of Belgium C8433
6 · The paper itself

Abstract

Epidemiological data suggest that the severe acute respiratory syndrome coronavirus 2 infection rate is higher in women than in men, but the death rate is lower, while women (>50 years) on menopausal hormone therapy (MHT) have a higher survival rate than those not on MHT. Classical oral estrogen enhances the synthesis of coagulation markers and may increase the risk of thromboembolic events that are common in coronavirus disease 2019 (COVID-19). The favorable hemostatic profile of estetrol (E4) might be suitable for use in women who are receiving estrogen treatment and contract COVID-19. A multicenter, randomized, double-blind, placebo-controlled, phase 2 study (NCT04801836) investigated the efficacy, safety, and tolerability of E4 versus placebo in hospitalized patients with moderate COVID-19. Eligible postmenopausal women and men (aged ≥ 18 years old) were randomized to E4 15 mg or placebo, once daily for 21 days, in addition to the standard of care (SoC). The primary efficacy endpoint of improvement in COVID-19 (percentage of patients recovered at day 28) between the placebo and E4 arms was not met. E4 was well tolerated, with no safety signals or thromboembolic events, suggesting that postmenopausal women can safely continue E4-based therapy in cases of moderate COVID-19 managed with SoC.

Indexed as

coagulationCOVID-19E4estetrolestrogenhospitalizationhuman fetal estrogenpostmenopausalthromboembolic events

Identifiers

PMID37373625
PMCPMC10299386
OpenAlexW4380085219

What OpenQuestion holds

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LicenceCC BY
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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 OpenQuestion graph.