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

{ 'indexed': {'date-parts': [[2022, 7, 10]], 'date-time': '2022-07-10T12:41:02Z', 'timestamp': 1657456862818}, 'reference-count': 30, 'publisher': 'Springer Science and Business Media LLC', 'issue': '1', 'license': [ { 'start': { 'date-parts': [[2022, 7, 9]], 'date-time': '2022-07-09T00:00:00Z', 'timestamp': 1657324800000}, 'content-version': 'tdm', 'delay-in-days': 0, 'URL': 'https://creativecommons.org/licenses/by/4.0'}, { 'start': { 'date-parts': [[2022, 7, 9]], 'date-time': '2022-07-09T00:00:00Z', 'timestamp': 1657324800000}, 'content-version': 'vor', 'delay-in-days': 0, 'URL': 'https://creativecommons.org/licenses/by/4.0'}], 'content-domain': {'domain': ['link.springer.com'], 'crossmark-restriction': False}, 'published-print': {'date-parts': [[2022, 12]]}, 'abstract': '<jats:title>Abstract</jats:title><jats:sec>\n' ' <jats:title>Background</jats:title>\n' ' <jats:p>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.</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Methods</jats:title>\n' ' <jats:p>In this single-center, open-label, randomised controlled trial, 900 ' 'RT-PCR positive COVID-19 patients requiring hospitalisation, were randomly assigned to ' 'receive\xa0either atorvastatin 40\xa0mg (Group A, n\u2009=\u2009224), aspirin 75\xa0mg (Group ' 'B, n\u2009=\u2009225), or both (Group C, n\u2009=\u2009225) in addition to standard of care ' 'for 10\xa0days or until discharge whichever was earlier or only standard of care (Group D, ' 'n\u2009=\u2009226). The primary outcome variable was clinical deterioration to WHO Ordinal ' 'Scale for Clinical Improvement\u2009≥\u20096. The secondary outcome was change in serum ' 'C-reactive protein, interleukin-6, and troponin I.</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Results</jats:title>\n' ' <jats:p>The primary outcome occurred in 25\xa0(2.8%) patients: 7\xa0(3.2%) in ' 'Group A, 3\xa0(1.4%) in Group B, 8\xa0(3.6%) in\xa0Group C, and\xa07\xa0(3.2%) in Group D. ' 'There was no difference in primary outcome across the study groups (P\u2009=\u20090.463). ' '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\u2009=\u20090.99; ' 'Aspirin: HR 0.7 (95% CI 0.27–1.81) P\u2009=\u20090.46]. The secondary outcomes revealed lower ' 'serum interleukin-6 levels among patients in Groups B and C. There was no excess of adverse ' 'events.</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Conclusions</jats:title>\n' ' <jats:p>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.</jats:p>\n' ' <jats:p><jats:italic>Trial Registry Number</jats:italic> CTRI/2020/07/026791 ' '(<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" ' 'xlink:href="http://ctri.nic.in">http://ctri.nic.in</jats:ext-link>; registered on ' '25/07/2020)</jats:p>\n' ' </jats:sec>', 'DOI': '10.1186/s12879-022-07570-5', 'type': 'journal-article', 'created': {'date-parts': [[2022, 7, 9]], 'date-time': '2022-07-09T07:02:59Z', 'timestamp': 1657350179000}, 'update-policy': 'http://dx.doi.org/10.1007/springer_crossmark_policy', 'source': 'Crossref', 'is-referenced-by-count': 0, 'title': 'Statin and aspirin as adjuvant therapy in hospitalised patients with SARS-CoV-2 infection: a ' 'randomised clinical trial (RESIST trial)', 'prefix': '10.1186', 'volume': '22', 'author': [ {'given': 'Nirmal', 'family': 'Ghati', 'sequence': 'first', 'affiliation': []}, {'given': 'Sushma', 'family': 'Bhatnagar', 'sequence': 'additional', 'affiliation': []}, {'given': 'Manjit', 'family': 'Mahendran', 'sequence': 'additional', 'affiliation': []}, {'given': 'Abhishek', 'family': 'Thakur', 'sequence': 'additional', 'affiliation': []}, {'given': 'Kshitij', 'family': 'Prasad', 'sequence': 'additional', 'affiliation': []}, {'given': 'Devesh', 'family': 'Kumar', 'sequence': 'additional', 'affiliation': []}, {'given': 'Tanima', 'family': 'Dwivedi', 'sequence': 'additional', 'affiliation': []}, {'given': 'Kalaivani', 'family': 'Mani', 'sequence': 'additional', 'affiliation': []}, {'given': 'Pawan', 'family': 'Tiwari', 'sequence': 'additional', 'affiliation': []}, {'given': 'Ritu', 'family': 'Gupta', 'sequence': 'additional', 'affiliation': []}, {'given': 'Anant', 'family': 'Mohan', 'sequence': 'additional', 'affiliation': []}, {'given': 'Anita', 'family': 'Saxena', 'sequence': 'additional', 'affiliation': []}, {'given': 'Randeep', 'family': 'Guleria', 'sequence': 'additional', 'affiliation': []}, {'given': 'Siddharthan', 'family': 'Deepti', 'sequence': 'additional', 'affiliation': []}], 'member': '297', 'published-online': {'date-parts': [[2022, 7, 9]]}, 'reference': [ { 'issue': '4', 'key': '7570_CR1', 'doi-asserted-by': 'publisher', 'first-page': '258', 'DOI': '10.1093/ehjcvp/pvaa042', 'volume': '6', 'author': 'V Castiglione', 'year': '2020', 'unstructured': 'Castiglione V, Chiriacò M, Emdin M, Taddei S, Vergaro G. 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The trial was approved by the institutional ethical ' 'committee (attached). Informed consent was obtained from all participants.', 'order': 2, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Ethics approval and consent to participate'}}, { 'value': 'Not applicable.', 'order': 3, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Consent for publication'}}, { 'value': 'We declare no competing interests.', 'order': 4, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Competing interests'}}], 'article-number': '606'}