Abstract
Background: Statins and aspirin have been proposed for treatment of COVID-19 because of their anti-inflammatory and anti-thrombotic properties. Several observational studies have shown favourable results. There is a need for a randomised controlled trial.
Methods: In this single-center, open-label, randomised controlled trial, 900 RT-PCR positive COVID-19 patients requiring hospitalisation, were randomly assigned to receive either atorvastatin 40 mg (Group A, n = 224), aspirin 75 mg (Group B, n = 225), or both (Group C, n = 225) in addition to standard of care for 10 days or until discharge whichever was earlier or only standard of care (Group D, n = 226). The primary outcome variable was clinical deterioration to WHO Ordinal Scale for Clinical Improvement ≥ 6. The secondary outcome was change in serum C-reactive protein, interleukin-6, and troponin I.
Results: The primary outcome occurred in 25 (2.8%) patients: 7 (3.2%) in Group A, 3 (1.4%) in Group B, 8 (3.6%) in Group C, and 7 (3.2%) in Group D. There was no difference in primary outcome across the study groups (P = 0.463). Comparison of all patients who received atorvastatin or aspirin with the control group (Group D) also did not show any benefit [Atorvastatin: HR 1.0 (95% CI 0.41-2.46) P = 0.99; Aspirin: HR 0.7 (95% CI 0.27-1.81) P = 0.46]. The secondary outcomes revealed lower serum interleukin-6 levels among patients in Groups B and C. There was no excess of adverse events.
Conclusions: Among patients admitted with mild to moderate COVID-19 infection, additional treatment with aspirin, atorvastatin, or a combination of the two does not prevent clinical deterioration. Trial Registry Number CTRI/2020/07/026791 ( http://ctri.nic.in ; registered on 25/07/2020).
Keywords: Aspirin; COVID-19; Serum IL-6; Statin; WHO ordinal scale.
【저자키워드】 COVID-19, statin, Aspirin, Serum IL-6, WHO ordinal scale., 【초록키워드】 Treatment, randomised controlled trial, Open-label, Anti-inflammatory, Infection, interleukin-6, C-reactive protein, RT-PCR, discharge, observational study, Moderate COVID-19, adverse events, improvement, serum, clinical, Patient, Mild, WHO, scale, troponin I, registry, group, hospitalisation, Combination, Clinical deterioration, Standard of care, number, Primary outcome, control group, 95% CI, no difference, Registered, single-center, secondary outcome, WHO ordinal scale, positive COVID-19, anti-thrombotic properties, Prevent, benefit, Randomly, shown, occurred, addition, assigned, receive, serum interleukin-6 level, the study group, 【제목키워드】 SARS-CoV-2, clinical trial, therapy, Trial, randomised, hospitalised patient,