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0 0.5 1 1.5 2+ Mortality 86% Improvement Relative Risk Vitamin D for COVID-19  Schmidt et al.  Sufficiency Are vitamin D levels associated with COVID-19 outcomes? Prospective study in Poland (February - December 2021) Lower mortality with higher vitamin D levels (p=0.003) c19early.org Schmidt et al., J. Clinical Medicine, Mar 2023 Favors vitamin D Favors control

Identification of Clinical Response Predictors of Tocilizumab Treatment in Patients with Severe COVID-19 Based on Single-Center Experience

Schmidt et al., Journal of Clinical Medicine, doi:10.3390/jcm12062429
Mar 2023  
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Vitamin D for COVID-19
8th treatment shown to reduce risk in October 2020
 
*, now known with p < 0.00000000001 from 120 studies, recognized in 8 countries.
No treatment is 100% effective. Protocols combine complementary and synergistic treatments. * >10% efficacy in meta analysis with ≥3 clinical studies.
4,200+ studies for 70+ treatments. c19early.org
Prospective study of 120 severe COVID-19 patients in Poland treated with tocilizumab, showing significantly higher mortality with low vitamin D levels.
This is the 166th of 196 COVID-19 sufficiency studies for vitamin D, which collectively show higher levels reduce risk with p<0.0000000001 (1 in 11,637 vigintillion).
risk of death, 85.5% lower, OR 0.14, p = 0.003, cutoff 27ng/mL, inverted to make OR<1 favor high D levels (≥27ng/mL), RR approximated with OR.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Schmidt et al., 22 Mar 2023, prospective, Poland, peer-reviewed, 4 authors, study period 4 February, 2021 - 31 December, 2021. Contact: wiktorpawelschmidt@gmail.com (corresponding author).
This PaperVitamin DAll
Identification of Clinical Response Predictors of Tocilizumab Treatment in Patients with Severe COVID-19 Based on Single-Center Experience
Wiktor Schmidt, Katarzyna Pawlak-Buś, Barbara Jóźwiak, Piotr Leszczyński
Journal of Clinical Medicine, doi:10.3390/jcm12062429
Hyperinflammation in COVID-19 plays a crucial role in pathogenesis and severity; thus, many immunomodulatory agents are applied in its treatment. We aimed to identify good clinical response predictors of tocilizumab (TCZ) treatment in severe COVID-19, among clinical, laboratory, and radiological variables. We conducted a prospective, observational study with 120 patients with severe COVID-19 not improving despite dexamethasone (DEX) treatment. We used parametric and non-parametric statistics, univariate logistic regression, receiver operating characteristic (ROC) curves, and nonlinear factors tertile analysis. In total, 86 (71.7%) patients achieved the primary outcome of a good clinical response to TCZ. We identified forty-nine predictive factors with potential utility in patient selection and treatment monitoring. The strongest included time from symptom onset between 9 and 12 days, less than 70% of estimated radiological lung involvement, and lower activity of lactate dehydrogenase. Additional predictors were associated with respiratory function, vitamin D concentration, comorbidities, and inflammatory/organ damage biomarkers. Adverse events analysis proved the safety of such a regimen. Our study confirmed that using TCZ early in the hyperinflammatory phase, before severe respiratory failure development, is most beneficial. Considering the described predictive factors, employing simple and widely available laboratory, radiological, and clinical tools can optimize patient selection for immunomodulatory treatment with TCZ.
Supplementary Materials: The following supporting information can be downloaded at: https://www. mdpi.com/article/10.3390/jcm12062429/s1, Table S1 . Definitions of additional outcomes of the study. Table S2 . Full demographic and initial clinical characteristics of study group, presented as n (%), mean (±SD) or median (Q1-Q3). Table S3 . Extended clinical characteristics of study groups, presented as median (Q1-Q3). p values were derived with Mann-Whitney U test. Table S4 . Extended laboratory characteristics of studied groups and outcomes, presented as median (Q1-Q3). p values were derived with Mann-Whitney U test. Table S5 . Outcomes and their prevalence upon administration and occurrence after treatment with tocilizumab in studied groups. Author Contributions: P.L. and K.P.-B. supervised the whole project. All authors participated in the conception and design of the study. P.L. conceived the analysis and W.S. designed it. Collection of data was performed by B.J. and W.S. Data were analyzed by W.S. and interpreted by W.S. and P.L. W.S. and B.J. were responsible for drafting the article, whereas K.P.-B. and P.L. gave critical revisions. All authors collectively gave final approval of the version of the article to be published. All authors have read and agreed to the published version of the manuscript. Conflicts of Interest: The authors declare no conflict of interest.
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{ 'DOI': '10.3390/jcm12062429', 'ISSN': ['2077-0383'], 'URL': 'http://dx.doi.org/10.3390/jcm12062429', 'abstract': '<jats:p>Hyperinflammation in COVID-19 plays a crucial role in pathogenesis and severity; ' 'thus, many immunomodulatory agents are applied in its treatment. We aimed to identify good ' 'clinical response predictors of tocilizumab (TCZ) treatment in severe COVID-19, among ' 'clinical, laboratory, and radiological variables. We conducted a prospective, observational ' 'study with 120 patients with severe COVID-19 not improving despite dexamethasone (DEX) ' 'treatment. We used parametric and non-parametric statistics, univariate logistic regression, ' 'receiver operating characteristic (ROC) curves, and nonlinear factors tertile analysis. In ' 'total, 86 (71.7%) patients achieved the primary outcome of a good clinical response to TCZ. ' 'We identified forty-nine predictive factors with potential utility in patient selection and ' 'treatment monitoring. The strongest included time from symptom onset between 9 and 12 days, ' 'less than 70% of estimated radiological lung involvement, and lower activity of lactate ' 'dehydrogenase. Additional predictors were associated with respiratory function, vitamin D ' 'concentration, comorbidities, and inflammatory/organ damage biomarkers. Adverse events ' 'analysis proved the safety of such a regimen. Our study confirmed that using TCZ early in the ' 'hyperinflammatory phase, before severe respiratory failure development, is most beneficial. ' 'Considering the described predictive factors, employing simple and widely available ' 'laboratory, radiological, and clinical tools can optimize patient selection for ' 'immunomodulatory treatment with TCZ.</jats:p>', 'alternative-id': ['jcm12062429'], 'author': [ { 'ORCID': 'http://orcid.org/0000-0002-9409-9827', 'affiliation': [ { 'name': 'Department of Rheumatology, Systemic Connective Tissue Diseases ' 'and Immunotherapy of Rheumatic Diseases, J. Strus Municipal ' 'Hospital, 61-285 Poznan, Poland'}, { 'name': 'Department of Internal Medicine, Poznan University of Medical ' 'Sciences, 61-701 Poznan, Poland'}, { 'name': 'Doctoral School, Poznan University of Medical Sciences, 60-812 ' 'Poznan, Poland'}], 'authenticated-orcid': False, 'family': 'Schmidt', 'given': 'Wiktor', 'sequence': 'first'}, { 'ORCID': 'http://orcid.org/0000-0002-1982-5980', 'affiliation': [ { 'name': 'Department of Rheumatology, Systemic Connective Tissue Diseases ' 'and Immunotherapy of Rheumatic Diseases, J. Strus Municipal ' 'Hospital, 61-285 Poznan, Poland'}, { 'name': 'Department of Internal Medicine, Poznan University of Medical ' 'Sciences, 61-701 Poznan, Poland'}], 'authenticated-orcid': False, 'family': 'Pawlak-Buś', 'given': 'Katarzyna', 'sequence': 'additional'}, { 'ORCID': 'http://orcid.org/0000-0002-7668-4221', 'affiliation': [ { 'name': 'Department of Rheumatology, Systemic Connective Tissue Diseases ' 'and Immunotherapy of Rheumatic Diseases, J. Strus Municipal ' 'Hospital, 61-285 Poznan, Poland'}], 'authenticated-orcid': False, 'family': 'Jóźwiak', 'given': 'Barbara', 'sequence': 'additional'}, { 'affiliation': [ { 'name': 'Department of Rheumatology, Systemic Connective Tissue Diseases ' 'and Immunotherapy of Rheumatic Diseases, J. Strus Municipal ' 'Hospital, 61-285 Poznan, Poland'}, { 'name': 'Department of Internal Medicine, Poznan University of Medical ' 'Sciences, 61-701 Poznan, Poland'}], 'family': 'Leszczyński', 'given': 'Piotr', 'sequence': 'additional'}], 'container-title': 'Journal of Clinical Medicine', 'container-title-short': 'JCM', 'content-domain': {'crossmark-restriction': False, 'domain': []}, 'created': {'date-parts': [[2023, 3, 22]], 'date-time': '2023-03-22T10:00:01Z', 'timestamp': 1679479201000}, 'deposited': { 'date-parts': [[2023, 3, 22]], 'date-time': '2023-03-22T11:59:58Z', 'timestamp': 1679486398000}, 'indexed': {'date-parts': [[2023, 3, 23]], 'date-time': '2023-03-23T04:56:29Z', 'timestamp': 1679547389554}, 'is-referenced-by-count': 0, 'issue': '6', 'issued': {'date-parts': [[2023, 3, 22]]}, 'journal-issue': {'issue': '6', 'published-online': {'date-parts': [[2023, 3]]}}, 'language': 'en', 'license': [ { 'URL': 'https://creativecommons.org/licenses/by/4.0/', 'content-version': 'vor', 'delay-in-days': 0, 'start': { 'date-parts': [[2023, 3, 22]], 'date-time': '2023-03-22T00:00:00Z', 'timestamp': 1679443200000}}], 'link': [ { 'URL': 'https://www.mdpi.com/2077-0383/12/6/2429/pdf', 'content-type': 'unspecified', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'member': '1968', 'original-title': [], 'page': '2429', 'prefix': '10.3390', 'published': {'date-parts': [[2023, 3, 22]]}, 'published-online': {'date-parts': [[2023, 3, 22]]}, 'publisher': 'MDPI AG', 'reference': [ { 'DOI': '10.1172/JCI154886', 'article-title': 'The intersection of COVID-19 and autoimmunity', 'author': 'Knight', 'doi-asserted-by': 'crossref', 'first-page': 'e154886', 'journal-title': 'J. 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Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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