Proactive anti-inflammatory therapy with colchicine in the treatment of advanced stages of new coronavirus infection. The first results of the COLORIT study

{ 'indexed': {'date-parts': [[2022, 2, 3]], 'date-time': '2022-02-03T03:26:04Z', 'timestamp': 1643858764463}, 'reference-count': 34, 'publisher': 'APO Society of Specialists in Heart Failure', 'issue': '2', 'license': [ { 'start': { 'date-parts': [[2021, 2, 28]], 'date-time': '2021-02-28T00:00:00Z', 'timestamp': 1614470400000}, 'content-version': 'vor', 'delay-in-days': 0, 'URL': 'https://lib.ossn.ru/jour/about/editorialPolicies#openAccessPolicy'}], 'content-domain': {'domain': [], 'crossmark-restriction': False}, 'short-container-title': ['Kardiologiia'], 'abstract': '<jats:p><jats:italic>Actuality</jats:italic> The course of the novel coronavirus disease ' '(COVID-19) is unpredictable. It manifests in some cases as increasing inflammation to even ' 'the onset of a cytokine storm and irreversible progression of acute respiratory syndrome, ' 'which is associated with the risk of death in patients. Thus, proactive anti-inflammatory ' 'therapy remains an open serious question in patients with COVID-19 and pneumonia, who still ' 'have signs of inflammation on days 7–9 of the disease: elevated C-reactive protein ' '(CRP)&gt;60 mg/dL and at least two of the four clinical signs: fever &gt;37.5°C; persistent ' 'cough; dyspnea (RR &gt;20 brpm) and/or reduced oxygen blood saturation &lt;94% when breathing ' 'atmospheric air. We designed the randomized trial: COLchicine versus Ruxolitinib and ' 'Secukinumab in Open-label Prospective Randomized Trial in Patients with COVID-19 (COLORIT). ' 'We present here data comparing patients who received colchicine with those who did not ' 'receive specific anti-inflammatory therapy. Results of the comparison of colchicine, ' 'ruxolitinib, and secukinumab will be presented later.<jats:italic>Objective</jats:italic> ' 'Compare efficacy and safety of colchicine compared to the management of patients with ' 'COVID-19 without specific anti-inflammatory therapy.<jats:italic>Material and ' 'Methods</jats:italic> Initially, 20 people were expected to be randomized in the control ' 'group. However, enrollment to the control group was discontinued subsequently after the ' 'inclusion of 5 patients due to the risk of severe deterioration in the absence of ' 'anti-inflammatory treatment. Therefore, 17 patients, who had not received anti-inflammatory ' 'therapy when treated in the MSU Medical Research and Educational Center before the study, ' 'were also included in the control group. The effects were assessed on day 12 after the ' 'inclusion or at discharge if it occurred earlier than on day 12. The primary endpoint was the ' 'changes in the SHOCS-COVID score, which includes the assessment of the patient’s clinical ' 'condition, CT score of the lung tissue damage, the severity of systemic inflammation (CRP ' 'changes), and the risk of thrombotic complications (D-dimer) ' '[1].<jats:italic>Results</jats:italic> The median SHOCS score decreased from 8 to 2 (p = ' '0.017), i.e., from moderate to mild degree, in the colchicine group. The change in the ' 'SHOCS-COVID score was minimal and statistically insignificant in the control group. In ' 'patients with COVID-19 treated with colchicine, the CRP levels decreased rapidly and ' 'normalized (from 99.4 to 4.2 mg/dL, p&lt;0.001). In the control group, the CRP levels ' 'decreased moderately and statistically insignificantly and achieved 22.8 mg/dL by the end of ' 'the follow-up period, which was still more than four times higher than normal. The most ' 'informative criterion for inflammation lymphocyte-to-C-reactive protein ratio (LCR) increased ' 'in the colchicine group by 393 versus 54 in the control group (p = 0.003). After treatment, ' 'it was 60.8 in the control group, which was less than 100 considered safe in terms of ' 'systemic inflammation progression. The difference from 427 in the colchicine group was highly ' 'significant (p = 0.003).The marked and rapid decrease in the inflammation factors was ' 'accompanied in the colchicine group by the reduced need for oxygen support from 14 (66.7%) to ' '2 (9.5%). In the control group, the number of patients without anti-inflammatory therapy ' 'requiring oxygen support remained unchanged at 50%. There was a trend to shorter hospital ' 'stays in the group of specific anti-inflammatory therapy up to 13 days compared to 17.5 days ' 'in the control group (p = 0.079). Moreover, two patients died in the control group, and there ' 'were no fatal cases in the colchicine group. In the colchicine group, one patient had deep ' 'vein thrombosis with D-dimer elevated to 5.99 µg/mL, which resolved before ' 'discharge.<jats:italic>Conclusions</jats:italic> Colchicine 1 mg for 1-3 days followed by 0.5 ' 'mg/day for 14 days is effective as a proactive anti-inflammatory therapy in hospitalized ' 'patients with COVID-19 and viral pneumonia. The management of such patients without proactive ' 'anti-inflammatory therapy is likely to be unreasonable and may worsen the course of COVID-19. ' 'However, the findings should be treated with caution, given the small size of the ' 'trial.</jats:p>', 'DOI': '10.18087/cardio.2021.2.n1560', 'type': 'journal-article', 'created': {'date-parts': [[2021, 3, 15]], 'date-time': '2021-03-15T06:53:07Z', 'timestamp': 1615791187000}, 'page': '15-27', 'source': 'Crossref', 'is-referenced-by-count': 15, 'title': [ 'Proactive anti-inflammatory therapy with colchicine in the treatment of advanced stages of new ' 'coronavirus infection. The first results of the COLORIT study'], 'prefix': '10.18087', 'volume': '61', 'author': [ { 'ORCID': 'http://orcid.org/0000-0002-7285-2048', 'authenticated-orcid': True, 'given': 'V. Yu.', 'family': 'Mareev', 'sequence': 'first', 'affiliation': [ { 'name': 'Medical Research and Educational Center of the M. V. Lomonosov ' 'Moscow State University, Moscow, Russia\r\n' 'Faculty of Fundamental Medicine, Lomonosov Moscow State ' 'University, Russia'}]}, { 'ORCID': 'http://orcid.org/0000-0002-8160-5612', 'authenticated-orcid': True, 'given': 'Ya. A.', 'family': 'Orlova', 'sequence': 'additional', 'affiliation': [ { 'name': 'Medical Research and Educational Center of the M. V. Lomonosov ' 'Moscow State University, Moscow, Russia\r\n' 'Faculty of Fundamental Medicine, Lomonosov Moscow State ' 'University, Russia'}]}, { 'given': 'A. G.', 'family': 'Plisyk', 'sequence': 'additional', 'affiliation': [ { 'name': 'Medical Research and Educational Center of the M. V. Lomonosov ' 'Moscow State University, Moscow, Russia\r\n' 'Faculty of Fundamental Medicine, Lomonosov Moscow State ' 'University, Russia'}]}, { 'ORCID': 'http://orcid.org/0000-0001-7693-5281', 'authenticated-orcid': True, 'given': 'E. P.', 'family': 'Pavlikova', 'sequence': 'additional', 'affiliation': [ { 'name': 'Medical Research and Educational Center of the M. V. Lomonosov ' 'Moscow State University, Moscow, Russia\r\n' 'Faculty of Fundamental Medicine, Lomonosov Moscow State ' 'University, Russia'}]}, { 'given': 'Z. A.', 'family': 'Akopyan', 'sequence': 'additional', 'affiliation': [ { 'name': 'Medical Research and Educational Center of the M. V. Lomonosov ' 'Moscow State University, Moscow, Russia\r\n' 'Faculty of Fundamental Medicine, Lomonosov Moscow State ' 'University, Russia'}]}, { 'given': 'S. T.', 'family': 'Matskeplishvili', 'sequence': 'additional', 'affiliation': [ { 'name': 'Medical Research and Educational Center of the M. V. Lomonosov ' 'Moscow State University, Moscow, Russia'}]}, { 'given': 'P. S.', 'family': 'Malakhov', 'sequence': 'additional', 'affiliation': [ { 'name': 'Medical Research and Educational Center of the M. V. Lomonosov ' 'Moscow State University, Moscow, Russia'}]}, { 'given': 'T. N.', 'family': 'Krasnova', 'sequence': 'additional', 'affiliation': [ { 'name': 'Medical Research and Educational Center of the M. V. Lomonosov ' 'Moscow State University, Moscow, Russia\r\n' 'Faculty of Fundamental Medicine, Lomonosov Moscow State ' 'University, Russia'}]}, { 'ORCID': 'http://orcid.org/0000-0002-1490-2078', 'authenticated-orcid': True, 'given': 'E. M.', 'family': 'Seredenina', 'sequence': 'additional', 'affiliation': [ { 'name': 'Medical Research and Educational Center of the M. V. Lomonosov ' 'Moscow State University, Moscow, Russia\r\n' 'Faculty of Fundamental Medicine, Lomonosov Moscow State ' 'University, Russia'}]}, { 'ORCID': 'http://orcid.org/0000-0002-9820-4276', 'authenticated-orcid': True, 'given': 'A. V.', 'family': 'Potapenko', 'sequence': 'additional', 'affiliation': [ { 'name': 'Medical Research and Educational Center of the M. V. Lomonosov ' 'Moscow State University, Moscow, Russia\r\n' 'Faculty of Fundamental Medicine, Lomonosov Moscow State ' 'University, Russia'}]}, { 'given': 'M. A.', 'family': 'Agapov', 'sequence': 'additional', 'affiliation': [ { 'name': 'Medical Research and Educational Center of the M. V. Lomonosov ' 'Moscow State University, Moscow, Russia\r\n' 'Faculty of Fundamental Medicine, Lomonosov Moscow State ' 'University, Russia'}]}, { 'ORCID': 'http://orcid.org/0000-0002-1939-7189', 'authenticated-orcid': True, 'given': 'D. A.', 'family': 'Asratyan', 'sequence': 'additional', 'affiliation': [ { 'name': 'Medical Research and Educational Center of the M. V. Lomonosov ' 'Moscow State University, Moscow, Russia'}]}, { 'given': 'L. I.', 'family': 'Dyachuk', 'sequence': 'additional', 'affiliation': [ { 'name': 'Medical Research and Educational Center of the M. V. Lomonosov ' 'Moscow State University, Moscow, Russia\r\n' 'Faculty of Fundamental Medicine, Lomonosov Moscow State ' 'University, Russia'}]}, { 'ORCID': 'http://orcid.org/0000-0001-6734-3989', 'authenticated-orcid': True, 'given': 'L. M.', 'family': 'Samokhodskaya', 'sequence': 'additional', 'affiliation': [ { 'name': 'Medical Research and Educational Center of the M. V. Lomonosov ' 'Moscow State University, Moscow, Russia\r\n' 'Faculty of Fundamental Medicine, Lomonosov Moscow State ' 'University, Russia'}]}, { 'ORCID': 'http://orcid.org/0000-0002-1266-4926', 'authenticated-orcid': True, 'given': 'Е. А.', 'family': 'Mershina', 'sequence': 'additional', 'affiliation': [ { 'name': 'Medical Research and Educational Center of the M. V. Lomonosov ' 'Moscow State University, Moscow, Russia\r\n' 'Faculty of Fundamental Medicine, Lomonosov Moscow State ' 'University, Russia'}]}, { 'ORCID': 'http://orcid.org/0000-0002-5649-2193', 'authenticated-orcid': True, 'given': 'V. E.', 'family': 'Sinitsyn', 'sequence': 'additional', 'affiliation': [ { 'name': 'Medical Research and Educational Center of the M. V. Lomonosov ' 'Moscow State University, Moscow, Russia\r\n' 'Faculty of Fundamental Medicine, Lomonosov Moscow State ' 'University, Russia'}]}, { 'given': 'P. V.', 'family': 'Pakhomov', 'sequence': 'additional', 'affiliation': [ { 'name': 'Faculty of Fundamental Medicine, Lomonosov Moscow State ' 'University, Russia'}]}, { 'ORCID': 'http://orcid.org/0000-0001-7992-6081', 'authenticated-orcid': True, 'given': 'E. A.', 'family': 'Zhdanova', 'sequence': 'additional', 'affiliation': [ { 'name': 'Medical Research and Educational Center of the M. V. Lomonosov ' 'Moscow State University, Moscow, Russia\r\n' 'Faculty of Fundamental Medicine, Lomonosov Moscow State ' 'University, Russia'}]}, { 'ORCID': 'http://orcid.org/0000-0002-1939-7189', 'authenticated-orcid': True, 'given': 'Yu. V.', 'family': 'Mareev', 'sequence': 'additional', 'affiliation': [ { 'name': 'National Medical Research Centre for Therapy and Preventive ' 'Medicine, Moscow, Russia\r\n' 'Robertson Centre for Biostatistics, Glasgow, Great Britain'}]}, { 'ORCID': 'http://orcid.org/0000-0001-7992-6081', 'authenticated-orcid': True, 'given': 'Yu. L.', 'family': 'Begrambekova', 'sequence': 'additional', 'affiliation': [ { 'name': 'Medical Research and Educational Center of the M. V. Lomonosov ' 'Moscow State University, Moscow, Russia\r\n' 'Faculty of Fundamental Medicine, Lomonosov Moscow State ' 'University, Russia'}]}, { 'ORCID': 'http://orcid.org/0000-0003-4251-7545', 'authenticated-orcid': True, 'given': 'А. А.', 'family': 'Kamalov', 'sequence': 'additional', 'affiliation': [ { 'name': 'Medical Research and Educational Center of the M. V. Lomonosov ' 'Moscow State University, Moscow, Russia\r\n' 'Faculty of Fundamental Medicine, Lomonosov Moscow State ' 'University, Russia'}]}], 'member': '7442', 'published-online': {'date-parts': [[2021, 2, 28]]}, 'container-title': ['Kardiologiia'], 'original-title': [], 'link': [ { 'URL': 'https://lib.ossn.ru/jour/article/viewFile/1560/911', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://lib.ossn.ru/jour/article/viewFile/1560/932', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'text-mining'}], 'deposited': { 'date-parts': [[2021, 3, 15]], 'date-time': '2021-03-15T06:56:02Z', 'timestamp': 1615791362000}, 'score': 1, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2021, 2, 28]]}, 'references-count': 34, 'journal-issue': {'issue': '2', 'published-online': {'date-parts': [[2021, 2, 28]]}}, 'URL': 'http://dx.doi.org/10.18087/cardio.2021.2.n1560', 'relation': {}, 'ISSN': ['2412-5660', '0022-9040'], 'issn-type': [{'value': '2412-5660', 'type': 'electronic'}, {'value': '0022-9040', 'type': 'print'}], 'subject': ['Cardiology and Cardiovascular Medicine'], 'published': {'date-parts': [[2021, 2, 28]]}}