Omega-3 fatty acids in addition to standard of care in the treatment of critically ill patients with COVID-19 (The OMEGA-COVID study), a randomized controlled multicenter trial

Q3 Nursing

Clinical Nutrition Open Science Pub Date : 2025-09-07 DOI:10.1016/j.nutos.2025.08.011

Ahmed Abd Elaziz Bahey Abd Elbari , Sandro B. Rizoli , Ruben Peralta , Talat Chughtai , Ayman El-Menyar , Hassan Ali Saoud Al Thani , Saibu George , Nadir Kharma , Mohammed Omar Saad , Hasan Mitwally , Mohamed Elkhateeb , Mostafa Elshafi , Ignacio Miguel Gomez Macineira , Anyali Bacallao , Ammar Ibrahim Abed Al-Hassani , Ibrahim Yassin Taha , Judith Jacobi , Airton Leonardo de Oliveira Manoel

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Abstract

Background

The efficacy and safety of omega-3 fatty acid in the treatment of severe acute respiratory syndrome remains controversial. We assessed if the addition of omega-3 fatty acid to standard of care would improve clinical outcomes in patients with SARS-CoV-2.

Methods: double blinded randomized clinical trial of adults with PCR-confirmed severe or critical COVID-19. Patients were enrolled through block stratified randomization to omega-3 fatty acid 2g enterally twice daily for 28 days in addition to standard of care vs. standard of care alone. The primary outcome was ventilator-free days at day 28. Secondary outcomes included length of ICU and hospital stay, and in-hospital mortality.

Results

380 patients (211 in the intervention group and 169 patients in the standard of care group). Ventilator-free days were similar between the intervention and standard of care groups [mean 12.4 days (9.3–15.5) vs 11.1 (7.2–15.0), P = 0.48), respectively]. There was no difference in the length of ICU (7 days for both groups) or hospital stay (Omega-3 = 16 days vs control = 15 days). Patients who received Omega-3 fatty acid had a trend toward lower mortality (4.3% vs 7.7%, P = 0.15). In pre-specified exploratory subgroup of mechanically ventilated patients (89 patients), Omega-3 group was associated with a significantly lower mortality (15.1% vs 33.3%, P = 0.04), however, the trial was not powered to detect mortality differences in this subgroup.

Conclusions

In patients with severe or critical COVID-19, the addition of Omega-3 fatty acids to standard of care did not increase ventilator-free days. An exploratory analysis suggested a possible mortality benefit in patients requiring mechanical ventilation, but the study was not powered for this endpoint, and these findings require confirmation in future trials.

Trial Registration

ClinicalTrials.gov, NCT04836052.

查看原文本刊更多论文

Omega-3脂肪酸在COVID-19危重患者治疗中的附加标准护理（OMEGA-COVID研究），一项随机对照多中心试验

背景：omega-3脂肪酸治疗严重急性呼吸综合征的有效性和安全性仍存在争议。我们评估了在标准护理中加入omega-3脂肪酸是否会改善SARS-CoV-2患者的临床结果。方法：对pcr确诊的成人重症、危重型COVID-19患者进行双盲随机临床试验。患者通过分组分层随机分组，在标准治疗组与单独标准治疗组的基础上，每天两次肠内注射omega-3脂肪酸2g，持续28天。主要终点为第28天无呼吸机天数。次要结局包括ICU和住院时间，以及住院死亡率。结果380例患者（干预组211例，标准护理组169例）。干预组和标准护理组无呼吸机天数相似[平均12.4天（9.3-15.5）vs 11.1天（7.2-15.0），P = 0.48]。ICU的时间（两组均为7天）或住院时间（Omega-3 = 16天，对照组= 15天）均无差异。接受Omega-3脂肪酸治疗的患者有降低死亡率的趋势（4.3% vs 7.7%, P = 0.15）。在预先指定的探索性机械通气患者亚组（89例患者）中，Omega-3组与显著较低的死亡率相关（15.1% vs 33.3%, P = 0.04），然而，该试验无法检测该亚组的死亡率差异。结论在重症或危重型COVID-19患者中，在标准护理中添加Omega-3脂肪酸并没有增加无呼吸机天数。一项探索性分析表明，在需要机械通气的患者中，可能会降低死亡率，但该研究没有为这一终点提供支持，这些发现需要在未来的试验中得到证实。临床试验注册中心，NCT04836052。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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