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Randomized Controlled Trial
. 2022 Jul 9;22(1):606.
doi: 10.1186/s12879-022-07570-5.

Statin and aspirin as adjuvant therapy in hospitalised patients with SARS-CoV-2 infection: a randomised clinical trial (RESIST trial)

Nirmal Ghati  1 , Sushma Bhatnagar  2 , Manjit Mahendran  3 , Abhishek Thakur  3 , Kshitij Prasad  3 , Devesh Kumar  3 , Tanima Dwivedi  4 , Kalaivani Mani  5 , Pawan Tiwari  6 , Ritu Gupta  7 , Anant Mohan  6 , Anita Saxena  3 , Randeep Guleria  6 , Siddharthan Deepti  8   9
Affiliations
Randomized Controlled Trial

Statin and aspirin as adjuvant therapy in hospitalised patients with SARS-CoV-2 infection: a randomised clinical trial (RESIST trial)

Nirmal Ghati et al. BMC Infect Dis. .

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.

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Conflict of interest statement

We declare no competing interests.

Figures

Fig. 1
Fig. 1
Consort flow diagram showing screening, recruitment, and randomisation of study participants. CPK Creatine phosphokinase, LFT Liver function test, ITT intention to treat
Fig. 2
Fig. 2
Probability of having WHO Ordinal Scale < 6 in the study groups over time. A is showing Kaplan–Meier estimates of freedom from primary outcome after initiation of the study drugs (atorvastatin, aspirin, and both) in comparison to the standard of care (modified ITT analysis). B and C are showing Kaplan–Meier estimates of probability of freedom from primary outcome in combined atorvastatin (Group A and Group C) and combined aspirin (Group B and Group C) groups respectively in comparison to the standard of care (modified ITT analysis). CI confidence interval, HR hazard ratio, WHO World Health Organisation
See this image and copyright information in PMC

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