Enoxaparin for outpatients with COVID-19: 90-day results from the randomised, open-label, parallel-group, multinational, phase III OVID trial.

Voci, Davide; Götschi, Andrea; Held, Ulrike; Bingisser, Roland; Colucci, Giuseppe; Duerschmied, Daniel; Fumagalli, Riccardo M; Gerber, Bernhard; Hasse, Barbara; Keller, Dagmar I; Konstantinides, Stavros V; Mach, François; Rampini, Silvana K; Righini, Marc; Robert-Ebadi, Helia; Rosemann, Thomas; Roth-Zetzsche, Stéphanie; Sebastian, Tim; Simon, Noemi R; Spirk, David; ... (2023). Enoxaparin for outpatients with COVID-19: 90-day results from the randomised, open-label, parallel-group, multinational, phase III OVID trial. Thrombosis research, 221, pp. 157-163. Elsevier 10.1016/j.thromres.2022.10.021

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INTRODUCTION

The benefits of early thromboprophylaxis in symptomatic COVID-19 outpatients remain unclear. We present the 90-day results from the randomised, open-label, parallel-group, investigator-initiated, multinational OVID phase III trial.

METHODS

Outpatients aged 50 years or older with acute symptomatic COVID-19 were randomised to receive enoxaparin 40 mg for 14 days once daily vs. standard of care (no thromboprophylaxis). The primary outcome was the composite of untoward hospitalisation and all-cause death within 30 days from randomisation. Secondary outcomes included arterial and venous major cardiovascular events, as well as the primary outcome within 90 days from randomisation. The study was prematurely terminated based on statistical criteria after the predefined interim analysis of 30-day data, which has been previously published. In the present analysis, we present the final, 90-day data from OVID and we additionally investigate the impact of thromboprophylaxis on the resolution of symptoms.

RESULTS

Of the 472 patients included in the intention-to-treat population, 234 were randomised to receive enoxaparin and 238 no thromboprophylaxis. The median age was 57 (Q1-Q3: 53-62) years and 217 (46 %) were women. The 90-day primary outcome occurred in 11 (4.7 %) patients of the enoxaparin arm and in 11 (4.6 %) controls (adjusted relative risk 1.00; 95 % CI: 0.44-2.25): 3 events per group occurred after day 30. The 90-day incidence of cardiovascular events was 0.9 % in the enoxaparin arm vs. 1.7 % in controls (relative risk 0.51; 95 % CI: 0.09-2.75). Individual symptoms improved progressively within 90 days with no difference between groups. At 90 days, 42 (17.9 %) patients in the enoxaparin arm and 40 (16.8 %) controls had persistent respiratory symptoms.

CONCLUSIONS

In adult community patients with COVID-19, early thromboprophylaxis with enoxaparin did not improve the course of COVID-19 neither in terms of hospitalisation and death nor considering COVID-19-related symptoms.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Pre-clinic Human Medicine > Institute of Pharmacology
04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology

UniBE Contributor:

Spirk, David, Stortecky, Stefan, Vaisnora, Lukas

Subjects:

600 Technology > 610 Medicine & health

ISSN:

0049-3848

Publisher:

Elsevier

Language:

English

Submitter:

Pubmed Import

Date Deposited:

23 Nov 2022 11:34

Last Modified:

23 May 2024 14:04

Publisher DOI:

10.1016/j.thromres.2022.10.021

PubMed ID:

36396519

Uncontrolled Keywords:

Anticoagulation COVID-19 Heparin SARS-CoV2 Thrombosis Venous thromboembolism

BORIS DOI:

10.48350/174933

URI:

https://boris.unibe.ch/id/eprint/174933

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