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Treating Covid-19 With Hydroxychloroquine (TEACH): A Multicenter, Double-Blind, Randomized Controlled Trial in Hospitalized Patients

Ulrich et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofaa446, TEACH, NCT04369742
Sep 2020  
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Mortality -6% Improvement Relative Risk Ventilation -52% ICU admission -173% HCQ for COVID-19  TEACH  LATE TREATMENT  RCT Is late treatment with HCQ beneficial for COVID-19? RCT 128 patients in the USA (April - May 2020) Higher ICU admission with HCQ (not stat. sig., p=0.13) c19hcq.org Ulrich et al., Open Forum Infectious D.., Sep 2020 FavorsHCQ Favorscontrol 0 0.5 1 1.5 2+
HCQ for COVID-19
1st treatment shown to reduce risk in March 2020, now with p < 0.00000000001 from 418 studies, recognized in 46 countries.
No treatment is 100% effective. Protocols combine treatments.
5,000+ studies for 104 treatments. c19hcq.org
Small RCT on very late stage use of HCQ, with 48% on oxygen at baseline. 67 HCQ patients, 61 control. Baseline states were not comparable - 82% more HCQ patients had the highest severity at baseline, there was 32% more male HCQ patients, and 44% more control patients used AZ. The HCQ group also had significantly more patients with cerebrovascular disease, cardiovascular disease (non-hypertension), renal disease (non-dialysis), and a history of organ transplants.
This study is excluded in the after exclusion results of meta analysis: very late stage, >50% on oxygen/ventilation at baseline.
risk of death, 6.0% higher, RR 1.06, p = 1.00, treatment 7 of 67 (10.4%), control 6 of 61 (9.8%).
risk of mechanical ventilation, 51.7% higher, RR 1.52, p = 0.72, treatment 5 of 67 (7.5%), control 3 of 61 (4.9%).
risk of ICU admission, 173.1% higher, RR 2.73, p = 0.13, treatment 9 of 67 (13.4%), control 3 of 61 (4.9%).
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Ulrich et al., 23 Sep 2020, Randomized Controlled Trial, USA, peer-reviewed, baseline oxygen required 63.3%, mean age 66.2, 18 authors, study period 17 April, 2020 - 12 May, 2020, average treatment delay 7.0 days, trial NCT04369742 (history) (TEACH).
This PaperHCQAll
TREATING COVID-19 WITH HYDROXYCHLOROQUINE (TEACH): A MULTICENTER, DOUBLE-BLIND, RANDOMIZED CONTROLLED TRIAL IN HOSPITALIZED PATIENTS
MD Robert J Ulrich, Andrea B Troxel Scd, MD Ellie Carmody, MD Jaishvi Eapen, MD Martin Bäcker, MD, MPH, MHCDS, FACP Jack A Dehovitz, MBBS Prithiv J Prasad, MS Yi Li, PhD Camila Delgado, MD Morris Jrada, MD Gabriel A Robbins, RN Brooklyn Henderson, MD Alexander Hrycko, MBBS Dinuli Delpachitra, MD Vanessa Raabe, MD Jonathan S Austrian, PharmD Yanina Dubrovskaya, MD, FIDSA Mark J Mulligan, Ave First, Clinicaltrials Gov # Nct04369742
doi:10.1093/ofid/ofaa446/5910201
Author Contributions: RJU, ABT, EC, VR and MJM contributed to the concept, design and protocol development. RJU, EC, JE, MB, JAD and PJP contributed as site leaders overseeing all trial operations and data quality from each site. MJ, GAR, BH, AH, DD and YD contributed to trial operations and data entry. RJU, ABT, CD, and YL contributed to data analysis. JSA created novel information technology for trial operations. RJU and ABT drafted the manuscript. All authors provided critical revisions and approved the final manuscript.
inancial Disclosures The authors have no relevant financial disclosures. Abbreviations: HCQ, hydroxychloroquine; IQR, interquartile range; SD, standard deviation; RT-PCR, reverse transcriptase polymerase chain reaction; AST, aspartate aminotransferase; ALT alanine aminotransferase; U, units; WBC, white blood cell count; LDH, lactic acid dehydrogenase
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Hydroxychloroquine (HCQ) has in vitro antiviral activity against severe ' 'acute respiratory syndrome coronavirus 2 (SARS-CoV-2), but the clinical benefit of HCQ in ' 'treating COVID-19 is unclear. Randomized controlled trials are needed to determine the safety ' 'and efficacy of HCQ for the treatment of hospitalized patients with COVID-19.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Methods</jats:title>\n' ' <jats:p>We conducted a multicenter, double-blind randomized clinical trial ' 'of HCQ among patients hospitalized with laboratory-confirmed COVID-19. Subjects were ' 'randomized in a 1:1 ratio to HCQ or placebo for 5 days and followed for 30 days. The primary ' 'efficacy outcome was a severe disease progression composite end point (death, intensive care ' 'unit admission, mechanical ventilation, extracorporeal membrane oxygenation, and/or ' 'vasopressor use) at day 14.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Results</jats:title>\n' ' <jats:p>A total of 128 patients were included in the intention-to-treat ' 'analysis. Baseline demographic, clinical, and laboratory characteristics were similar between ' 'the HCQ (n\u2005=\u200567) and placebo (n\u2005=\u200561) arms. At day 14, 11 (16.4%) ' 'subjects assigned to HCQ and 6 (9.8%) subjects assigned to placebo met the severe disease ' 'progression end point, but this did not achieve statistical significance (P\u2005=\u2005' '.350). There were no significant differences in COVID-19 clinical scores, number of ' 'oxygen-free days, SARS-CoV-2 clearance, or adverse events between HCQ and placebo. HCQ was ' 'associated with a slight increase in mean corrected QT interval, an increased D-dimer, and a ' 'trend toward an increased length of stay.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Conclusions</jats:title>\n' ' <jats:p>In hospitalized patients with COVID-19, our data suggest that HCQ ' 'does not prevent severe outcomes or improve clinical scores. However, our conclusions are ' 'limited by a relatively small sample size, and larger randomized controlled trials or pooled ' 'analyses are needed.</jats:p>\n' ' </jats:sec>', 'DOI': '10.1093/ofid/ofaa446', 'type': 'journal-article', 'created': {'date-parts': [[2020, 9, 23]], 'date-time': '2020-09-23T05:34:34Z', 'timestamp': 1600839274000}, 'source': 'Crossref', 'is-referenced-by-count': 47, 'title': 'Treating COVID-19 With Hydroxychloroquine (TEACH): A Multicenter, Double-Blind Randomized ' 'Controlled Trial in Hospitalized Patients', 'prefix': '10.1093', 'volume': '7', 'author': [ { 'ORCID': 'http://orcid.org/0000-0002-3217-5062', 'authenticated-orcid': False, 'given': 'Robert J', 'family': 'Ulrich', 'sequence': 'first', 'affiliation': [ { 'name': 'Department of Medicine, New York University Grossman School of ' 'Medicine, New York, New York, USA'}, { 'name': 'Division of Infectious Diseases and Immunology, New York ' 'University Grossman School of Medicine, New York, New York, ' 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'2020102711010509200_CIT0035'}, { 'key': '2020102711010509200_CIT0036', 'doi-asserted-by': 'crossref', 'first-page': '1', 'DOI': '10.1016/S0034-5288(18)30477-6', 'article-title': 'In ovo interference of embryo non-lethal avian infectious bronchitis ' 'viruses (IBV) with velogenic Newcastle disease virus and embryo adapted ' 'IBV', 'volume': '40', 'author': 'Yachida', 'year': '1986', 'journal-title': 'Res Vet Sci'}, { 'key': '2020102711010509200_CIT0037', 'doi-asserted-by': 'crossref', 'first-page': '863', 'DOI': '10.1016/j.vaccine.2018.12.040', 'article-title': 'Demonstrating vaccine effectiveness during a waning epidemic: a WHO/NIH ' 'meeting report on approaches to development and licensure of Zika ' 'vaccine candidates', 'volume': '37', 'author': 'Vannice', 'year': '2019', 'journal-title': 'Vaccine'}, {'key': '2020102711010509200_CIT0038', 'author': 'COVID-19 Collaborative Platform–COVID-CP'}, { 'key': '2020102711010509200_CIT0039', 'doi-asserted-by': 'crossref', 'first-page': '543', 'DOI': '10.1001/jama.2020.13042', 'article-title': 'Pooling data from individual clinical trials in the COVID-19 era', 'volume': '324', 'author': 'Petkova', 'year': '2020', 'journal-title': 'JAMA'}, { 'key': '2020102711010509200_CIT0040', 'doi-asserted-by': 'crossref', 'first-page': '1054', 'DOI': '10.1093/ajcn/86.4.1054', 'article-title': 'Calcium requirements: new estimations for men and women by ' 'cross-sectional statistical analyses of calcium balance data from ' 'metabolic studies', 'volume': '86', 'author': 'Hunt', 'year': '2007', 'journal-title': 'Am J Clin Nutr'}], 'container-title': 'Open Forum Infectious Diseases', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'http://academic.oup.com/ofid/advance-article-pdf/doi/10.1093/ofid/ofaa446/33782144/ofaa446.pdf', 'content-type': 'application/pdf', 'content-version': 'am', 'intended-application': 'syndication'}, { 'URL': 'http://academic.oup.com/ofid/article-pdf/7/10/ofaa446/34043569/ofaa446.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'syndication'}, { 'URL': 'http://academic.oup.com/ofid/article-pdf/7/10/ofaa446/34043569/ofaa446.pdf', 'content-type': 'unspecified', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2020, 10, 27]], 'date-time': '2020-10-27T15:06:39Z', 'timestamp': 1603811199000}, 'score': 1, 'resource': {'primary': {'URL': 'https://academic.oup.com/ofid/article/doi/10.1093/ofid/ofaa446/5910201'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2020, 9, 23]]}, 'references-count': 40, 'journal-issue': {'issue': '10', 'published-print': {'date-parts': [[2020, 10, 1]]}}, 'URL': 'http://dx.doi.org/10.1093/ofid/ofaa446', 'relation': {}, 'ISSN': ['2328-8957'], 'subject': ['Infectious Diseases', 'Oncology'], 'published-other': {'date-parts': [[2020, 10]]}, 'published': {'date-parts': [[2020, 9, 23]]}}
Late treatment
is less effective
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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