Efficacy and safety of combined nebulization of unfractionated heparin, acetylcysteine, budesonide and ipratropium bromide in hospitalised patients with COVID-19 pneumonia: a randomized controlled clinical trial
Abstract
Promoting the absorption of COVID-19 pneumonia is critical for reducing pulmonary sequelae and improving prognosis. This study aimed to evaluate the efficacy and safety of nebulized unfractionated heparin, acetylcysteine, budesonide, and ipratropium bromide (HABIT) in hospitalized patients with COVID-19 pneumonia. This single-center, open-label, randomized, parallel-group trial was conducted at a tertiary hospital in China. Participants were randomized 1:1 to receive either standard of care (SOC) or SOC plus nebulized HABIT. The HABIT protocol included daily quadruple nebulization for seven days, comprising 6000 units heparin sodium, 2 mg budesonide, 0.3 g acetylcysteine, and 0.5 mg ipratropium bromide. The primary outcome was the change in lung lesions assessed by chest CT scans on admission (Day 0) and post-treatment (Day 8). A total of 74 patients were randomized to the HABIT group (n = 37) or the control group (n = 37). Four patients per group were excluded during follow-up, leaving 66 patients for final analysis. Baseline CT scores were comparable between groups (10.55 ± 3.11 vs. 10.76 ± 2.85, p = 0.774). Post-treatment, the HABIT group showed significantly lower mean CT scores (6.6 ± 2.98 vs. 8.69 ± 2.53, p = 0.003) and greater lesion absorption (37.5% vs. 20%, p < 0.001) compared to controls. The HABIT group also exhibited a non-significant improvement in PaO2/FiO2 (75.27 vs. 51.23, p = 0.113). Safety analysis showed no significant differences in activated partial…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 74 participants or records.
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