Evidence map›Paper›PMID 37350990›Full record

ArticleEClinicalMedicine2023

Effect of weight-adjusted intermediate-dose versus fixed-dose prophylactic anticoagulation with low-molecular-weight heparin on venous thromboembolism among noncritically and critically ill patients with COVID-19: the COVI-DOSE trial, a multicenter, randomised, open-label, phase 4 trial.

Stéphane Zuily, Benjamin Lefèvre, Olivier Sanchez, Ombeline Empis de Vendin, Guillaume de Ciancio, Jean-Benoît Arlet, Lina Khider, Béatrice Terriat, Hélène Greigert, Céline S Robert and 30 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in EClinicalMedicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04373707 (Effectiveness of Weight-adjusted Prophylactic Low Molecular Weight Heparin Doses Compared With Lower Fixed Prophylactic Doses to Prevent Venous Thromboembolism in COVID-2019. The Multicenter Randomized Controlled Open-label Trial COVI-DOSE), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
4.2field-weighted citation impact, top 5% 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.

NCT04373707 phase4completednot on this map

Effectiveness of Weight-adjusted Prophylactic Low Molecular Weight Heparin Doses Compared With Lower Fixed Prophylactic Doses to Prevent Venous Thromboembolism in COVID-2019. The Multicenter Randomized Controlled Open-label Trial COVI-DOSE

TypeinterventionalSponsorCentral Hospital, Nancy, FranceRan2020 to 2021Enrolled1,000ConditionsCOVID, Thrombosis, Pulmonary Embolism, Deep Vein ThrombosisArmsEnoxaparin
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.

  1. Pooled it
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  7. Observational
  8. Review
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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

40 authors at 20 institutions in 3 countries.

Stéphane ZuilyVascular Medicine Division, Université de Lorraine, CHRU-Nancy, Rare Vascular and Systemic Autoimmune Diseases Regional Referral Center, France.
Benjamin LefèvreDepartment of Infectious and Tropical Diseases, Université de Lorraine, CHRU-Nancy, APEMAC, F-54000 Nancy, France.
Olivier SanchezDepartment of Respiratory and Intensive Care Medicine, Université Paris Cité, AP-HP, Hôpital Européen Georges Pompidou, F-75015 Paris, France.
Ombeline Empis de VendinDepartment of Surgical Intensive Care Unit, CHRU-Nancy, F-54000 Nancy, France.
Guillaume de CiancioDepartment of Cardiology, CHRU-Nancy, F-54000 Nancy, France.
Jean-Benoît ArletInternal Medicine Department, AP-HP, Hôpital Européen Georges Pompidou, APHP, F-75015 Paris, France.
Lina KhiderVascular Medicine Department, Université de Paris, AP-HP, Hôpital Européen Georges Pompidou, F-75015 Paris, France.
Béatrice TerriatDepartment of Vascular Medicine and Angiology, Dijon University Hospital, F-21000 Dijon, France.
Hélène GreigertDepartment of Vascular Medicine and Angiology, Dijon University Hospital, F-21000 Dijon, France.
Céline S RobertDepartment of Infectious Diseases, CHR Metz-Thionville, F-57000 Metz, France.
Guillaume LouisIntensive Care Unit, CHR Metz-Thionville, F-57000 Metz, France.
Albert Trinh-DucInternal Medicine Department, CH St Esprit, F-47000 Agen, France.
Patrick RispalInternal Medicine Department, CH St Esprit, F-47000 Agen, France.
Sandrine AccassatDepartment of Vascular Medicine, CHU Saint-Etienne, F-42000 Saint-Etienne, France.
Guillaume ThieryMedical Intensive Care Unit, CHU Saint-Etienne, F-42000 Saint-Etienne, France.
David MontaniDepartment of Respiratory and Intensive Care Medicine, Université Paris-Saclay, AP-HP, Hôpital Bicêtre, Pulmonary Hypertension National Referral Center, F-94270 Le Kremlin-Bicêtre, France.
Réza AzarianDepartment of Respiratory Medicine, CH Versailles, F-78150 Le Chesnay, France.
Nicolas MeneveauDepartment of Cardiology, Université de Franche-Comté, CHU Jean Minjoz, EA 3929, F-25000 Besancon, France.
Simon SoudetDepartment of Vascular Medicine, CHU Amiens-Picardie, F-80000 Amiens, France.
Raphaël Le MaoDepartment of Internal Medicine, Vascular Medicine and Pulmonology, CHU Brest, F-29200 Brest, France.
François MaurierDepartment of Internal Medicine, UNEOS, F-57070 Metz-Vantoux, France.
Vincent Le MoingDepartment of Infectious and Tropical Diseases, CHRU Montpellier, F-34000 Montpellier, France.
Isabelle QuéréDepartment of Vascular Medicine, CHU Montpellier, IDESP, F-34000 Montpellier, France.
Cécile M YelnikDepartment of Internal Medicine and Clinical Immunology, Université de Lille, CHU Lille, Inserm UMR 1167, North and North-West Systemic and Autoimmune Disease National Referral Center (CeRAINO), F-59000 Lille, France.
Nicolas LefebvreDepartment of Tropical and Infectious Diseases, Hôpitaux Universitaires de Strasbourg, F-67000 Strasbourg, France.
Martin MartinotDepartment of Tropical and Infectious Diseases, Hôpitaux Civils de Colmar, F-68000 Colmar, France.
Maxime DelrueHematology Laboratory and Thrombosis Unit, Lariboisière Hospital, APHP, Paris, France.
Ygal BenhamouDepartment of Internal Medicine, Normandie Université, Université de Rouen Normandie, Inserm UMR 1096, F-76000 Rouen, France.
Florence ParentDepartment of Respiratory and Intensive Care Medicine, Université Paris-Saclay, AP-HP, Hôpital Bicêtre, Pulmonary Hypertension National Referral Center, F-94270 Le Kremlin-Bicêtre, France.
Pierre-Marie RoyDepartment of Emergency Medicine, Université d'Angers, CHU Angers, F-49000 Angers, France.
Emilie PreslesUniversité Jean Monnet, Inserm, U1059 SAINBIOSE, France.
François GoehringerDepartment of Infectious and Tropical Diseases, CHRU-Nancy, F-54000 Nancy, France.
Patrick MismettiUniversité Jean Monnet, Inserm, U1059 SAINBIOSE, France.
Laurent BertolettiUniversité Jean Monnet, Inserm, CIC-1408, CHU Saint-Etienne, Service de Médecine Vasculaire et Thérapeutique, France.
Patrick RossignolUniversité de Lorraine, Inserm, CIC-P 1433, CHRU-Nancy, Inserm UMR 1116, F-CRIN INI-CRCT, F-54000 Nancy, France.
Francis CouturaudDepartment of Internal Medicine and Chest Diseases, Université de Bretagne Occidentale, CHU Brest, France.
Denis WahlVascular Medicine Division, Université de Lorraine, CHRU-Nancy, Rare Vascular and Systemic Autoimmune Diseases Regional Referral Center, France.
Nathalie ThillyDépartement Méthodologie, Promotion, Investigation, Université de Lorraine, CHRU-Nancy, APEMAC, , F-54000 Nancy, France.
Silvy LaporteUniversité Jean Monnet, Inserm, U1059 SAINBIOSE, France.
COVI-DOSE investigators
Inserm · FRInterdisciplinarité en Santé Publique Interventions et Instruments de mesure complexes – Région Est · FRCentre Hospitalier Universitaire d'Angers · FRCentre Hospitalier Régional et Universitaire de Nancy · FRUniversité Paris-Saclay · FRMaison des Sciences sociales et des Humanités de Dijon · FRAssistance Publique – Hôpitaux de Paris · FRCentre Hospitalier Universitaire de Montpellier · FRCentre Hospitalier Universitaire de Saint-Étienne · FRCentre Hospitalier Régional de Metz-Thionville · FRCentre Hospitalier Régional Universitaire de Brest · FRCentre Hospitalier Universitaire Amiens-Picardie · FRHopitaux Civils de Colmar · FRCentre Hospitalier Agen - Nérac · FRUniversité de Lorraine · FRCentre Hospitalier de Versailles · FRHôpital Lapeyronie · FRHôpitaux Universitaires de Strasbourg · FRUniversal Sensors (United States) · USUniversité de franche-comté · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Venous thromboembolism is a major complication of coronavirus disease 2019 (COVID-19). We hypothesized that a weight-adjusted intermediate dose of anticoagulation may decrease the risk of venous thromboembolism COVID-19 patients. Methods: In this multicenter, randomised, open-label, phase 4, superiority trial with blinded adjudication of outcomes, we randomly assigned adult patients hospitalised in 20 French centers and presenting with acute respiratory SARS-CoV-2. Eligible patients were randomly assigned (1:1 ratio) to receive an intermediate weight-adjusted prophylactic dose or a fixed-dose of subcutaneous low-molecular-weight heparin during the hospital stay. The primary outcome corresponded to symptomatic deep-vein thrombosis (fatal) pulmonary embolism during hospitalization (COVI-DOSE ClinicalTrials.gov number: NCT04373707). Findings: Between May 2020, and April 2021, 1000 patients underwent randomisation in medical wards (noncritically ill) (80.1%) and intensive care units (critically ill) (19.9%); 502 patients were assigned to receive a weight-adjusted intermediate dose, and 498 received fixed-dose thromboprophylaxis. Symptomatic venous thromboembolism occurred in 6 of 502 patients (1.2%) in the weight-adjusted dose group and in 10 of 498 patients (2.1%) in the fixed-dose group (subdistribution hazard ratio, 0.59; 95% CI, 0.22-1.63; P = 0.31). There was a twofold increased risk of major or clinically relevant nonmajor bleeding: 5.9% in the weight-adjusted dose group and 3.1% in the fixed-dose group (P = 0.034). Interpretation: In the COVI-DOSE trial, the observed rate of thromboembolic events was lower than expected in patients hospitalized for COVID-19 infection, and the study was unable to show a significant difference in the risk of venous thromboembolism between the two low-molecular-weight-heparin regimens. Funding: French Ministry of Health, CAPNET, Grand-Est Region, Grand-Nancy Métropole.

Indexed as

AnticoagulationCOVID-19HeparinVenous thromboembolism

Identifiers

PMID37350990
PMCPMC10250778
OpenAlexW4380090312

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.