Programmheft

Sitzung

47 - Young Investigator Meeting
Young Investigator Meeting
4. November 2022, 13:00 - 14:00, Gartensaal 2

Abstract

Enoxaparin for symptomatic outpatients with COVID-19: 90-day results from the randomised, open-label, parallel-group, multicentre, phase III OVID trial
D. Voci1, A. Götschi1, U. Held1, R. Bingisser2, G. Colucci3, D. Duerschmied4, B. Gerber5, D. Keller6, S. V. Konstantinides7, F. Mach8, M. Righini8, T. Rosemann6, S. Stortecky9, N. Kucher6, S. Barco6, Presenter: D. Voci1 (1Zürich, 2Basel, 3Lugano, 4Heildelberg, 5Bellinzona, 6Zurich, 7Mainz, 8Geneva, 9Bern)

Objective
It is unclear whether it may improve the course of COVID-19 among outpatients beyond the acute phase, including that of COVID-19-related symptoms. We present the final, 90-day results of the OVID phase III randomised controlled trial.
Methods
OVID was a randomised, open-label, parallel-group, investigator-initiated phase III superiority trial conducted at Swiss and German centres between August 2020 and January 2022. Patients with a positive test for SARS-CoV2, aged 50 years or older, with acute respiratory symptoms or body temperature >37.5°C, and eligible for ambulatory treatment were screened. Patients were randomised to receive either enoxaparin 40 mg subcutaneously for 14 days or no thromboprophylaxis. The primary endpoint was the composite of untoward hospitalisation and all-cause death within 90 days. Secondary endpoints included major cardiovascular events within 90 days. We studied COVID-19-related symptoms in the two treatment arms over time: data was prospectively collected during follow-up telephone visits at day 3, 7, 14, 30, and 90.
Results
We randomised 475 patients at nine sites in Switzerland and Germany from August 2020 through January 2022. The final intention to treat (ITT) population consisted of 472 individuals: 234 in the enoxaparin arm and 238 in the control arm. Median age was 57 (Q1-Q3: 53-62), 217 (46%) patients were women. The primary efficacy outcome occurred in 11 (4.7%) patients of the enoxaparin group and in 11 (4.6%) of controls within 90 days after randomisation (adjusted relative risk 1.00; 95%CI: 0.44-2.25; Figure 1). In the enoxaparin arm, 2 (0.9%) patients had a cardiovascular event vs. 4 (1.7%) in the standard-of-care arm (relative risk 0.51; 95%CI: 0.09-2.75). The prevalence of COVID-19-related symptoms showed a declining trend over 90 days, which was similar in the two treatment arms; Figure 2. A total of 42 (17.9%) patients in the enoxaparin group and 40 (16.8%) patients in the control group had persistent respiratory symptoms (cough, rhinorrhea, expectoration, sore throat, dyspnea) at 90 days.
Conclusion
Early treatment with low-molecular-weight heparin did not improve the course of COVID-19 in adult symptomatic outpatients in terms of hospitalisations, deaths, and COVID-19-related symptoms over 90-day follow-up.
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