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Hydroxychloroquine in the treatment of outpatients with mildly symptomatic COVID-19: A multi-center observational study

Ip et al., BMC Infectious Diseases, doi:10.1186/s12879-021-05773-w (date from preprint)
Aug 2020  
  Source   PDF   All Studies   Meta AnalysisMeta
Mortality 55% Improvement Relative Risk ICU admission 29% Hospitalization 37% HCQ for COVID-19  Ip et al.  EARLY TREATMENT Is early treatment with HCQ beneficial for COVID-19? Retrospective 1,067 patients in the USA Lower hospitalization with HCQ (p=0.038) Ip et al., BMC Infectious Diseases, Aug 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 411 studies, recognized in 46 countries.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,300+ studies for 75 treatments.
Retrospective 1,274 outpatients, 47% reduction in hospitalization with HCQ with propensity matching, HCQ OR 0.53 [0.29-0.95]. Sensitivity analyses revealed similar associations.
Adverse events were not increased (2% QTc prolongation events, 0% arrhythmias).
risk of death, 54.5% lower, RR 0.45, p = 0.43, treatment 2 of 97 (2.1%), control 44 of 970 (4.5%), NNT 40.
risk of ICU admission, 28.6% lower, RR 0.71, p = 0.79, treatment 3 of 97 (3.1%), control 42 of 970 (4.3%), NNT 81.
risk of hospitalization, 37.3% lower, RR 0.63, p = 0.04, treatment 21 of 97 (21.6%), control 305 of 970 (31.4%), NNT 10, adjusted per study, odds ratio converted to relative risk.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Ip et al., 25 Aug 2020, retrospective, database analysis, USA, peer-reviewed, 25 authors, dosage not specified.
This PaperHCQAll
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We aimed to explore the role of hydroxychloroquine therapy in mildly symptomatic ' 'patients diagnosed in the outpatient setting.</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Methods</jats:title>\n' ' <jats:p>We examined the association between outpatient hydroxychloroquine ' 'exposure and the subsequent progression of disease among mildly symptomatic non-hospitalized ' 'patients with documented SARS-CoV-2 infection. The primary outcome assessed was requirement ' 'of hospitalization. Data was obtained from a retrospective review of electronic health ' 'records within a New Jersey USA multi-hospital network. We compared outcomes in patients who ' 'received hydroxychloroquine with those who did not applying a multivariable logistic model ' 'with propensity matching.</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Results</jats:title>\n' ' <jats:p>Among 1274 outpatients with documented SARS-CoV-2 infection 7.6% were ' 'prescribed hydroxychloroquine. In a 1067 patient propensity matched cohort, 21.6% with ' 'outpatient exposure to hydroxychloroquine were hospitalized, and 31.4% without exposure were ' 'hospitalized. In the primary multivariable logistic regression analysis with propensity ' 'matching there was an association between exposure to hydroxychloroquine and a decreased rate ' 'of hospitalization from COVID-19 (OR 0.53; 95% CI, 0.29, 0.95). Sensitivity analyses revealed ' 'similar associations. QTc prolongation events occurred in 2% of patients prescribed ' 'hydroxychloroquine with no reported arrhythmia events among those with data ' 'available.</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Conclusions</jats:title>\n' ' <jats:p>In this retrospective observational study of SARS-CoV-2 infected ' 'non-hospitalized patients hydroxychloroquine exposure was associated with a decreased rate of ' 'subsequent hospitalization. Additional exploration of hydroxychloroquine in this mildly ' 'symptomatic outpatient population is warranted.</jats:p>\n' ' </jats:sec>', 'DOI': '10.1186/s12879-021-05773-w', 'type': 'journal-article', 'created': {'date-parts': [[2021, 1, 14]], 'date-time': '2021-01-14T11:03:19Z', 'timestamp': 1610622199000}, 'update-policy': '', 'source': 'Crossref', 'is-referenced-by-count': 36, 'title': 'Hydroxychloroquine in the treatment of outpatients with mildly symptomatic COVID-19: a ' 'multi-center observational study', 'prefix': '10.1186', 'volume': '21', 'author': [ { 'ORCID': '', 'authenticated-orcid': False, 'given': 'Andrew', 'family': 'Ip', 'sequence': 'first', 'affiliation': []}, {'given': 'Jaeil', 'family': 'Ahn', 'sequence': 'additional', 'affiliation': []}, {'given': 'Yizhao', 'family': 'Zhou', 'sequence': 'additional', 'affiliation': []}, {'given': 'Andre H.', 'family': 'Goy', 'sequence': 'additional', 'affiliation': []}, {'given': 'Eric', 'family': 'Hansen', 'sequence': 'additional', 'affiliation': []}, {'given': 'Andrew L.', 'family': 'Pecora', 'sequence': 'additional', 'affiliation': []}, {'given': 'Brittany A.', 'family': 'Sinclaire', 'sequence': 'additional', 'affiliation': []}, {'given': 'Urszula', 'family': 'Bednarz', 'sequence': 'additional', 'affiliation': []}, {'given': 'Michael', 'family': 'Marafelias', 'sequence': 'additional', 'affiliation': []}, {'given': 'Ihor S.', 'family': 'Sawczuk', 'sequence': 'additional', 'affiliation': []}, { 'suffix': 'III', 'given': 'Joseph P.', 'family': 'Underwood', 'sequence': 'additional', 'affiliation': []}, {'given': 'David M.', 'family': 'Walker', 'sequence': 'additional', 'affiliation': []}, {'given': 'Rajiv', 'family': 'Prasad', 'sequence': 'additional', 'affiliation': []}, {'given': 'Robert L.', 'family': 'Sweeney', 'sequence': 'additional', 'affiliation': []}, {'given': 'Marie G.', 'family': 'Ponce', 'sequence': 'additional', 'affiliation': []}, {'given': 'Samuel', 'family': 'La Capra', 'sequence': 'additional', 'affiliation': []}, {'given': 'Frank J.', 'family': 'Cunningham', 'sequence': 'additional', 'affiliation': []}, {'given': 'Arthur G.', 'family': 'Calise', 'sequence': 'additional', 'affiliation': []}, {'given': 'Bradley L.', 'family': 'Pulver', 'sequence': 'additional', 'affiliation': []}, {'given': 'Dominic', 'family': 'Ruocco', 'sequence': 'additional', 'affiliation': []}, {'given': 'Greggory E.', 'family': 'Mojares', 'sequence': 'additional', 'affiliation': []}, {'given': 'Michael P.', 'family': 'Eagan', 'sequence': 'additional', 'affiliation': []}, {'given': 'Kristy L.', 'family': 'Ziontz', 'sequence': 'additional', 'affiliation': []}, {'given': 'Paul', 'family': 'Mastrokyriakos', 'sequence': 'additional', 'affiliation': []}, {'given': 'Stuart L.', 'family': 'Goldberg', 'sequence': 'additional', 'affiliation': []}], 'member': '297', 'published-online': {'date-parts': [[2021, 1, 14]]}, 'reference': [ { 'key': '5773_CR1', 'volume-title': 'Infectious diseases Society of America guidelines on the treatment and ' 'management of patients with COVID-19', 'author': 'A Bhimraj', 'year': '2020', 'unstructured': 'Bhimraj A, Morgan RL, Shumaker AH, Lavergne V, Baden L, Cheng VC, et al. 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MedRxiv. ' '2020.', 'DOI': '10.1101/2020.09.30.20204693'}, { 'key': '5773_CR37', 'doi-asserted-by': 'publisher', 'first-page': '656', 'DOI': '10.1097/RCT.0000000000001075', 'volume': '44', 'author': 'AAKA Razek', 'year': '2020', 'unstructured': 'Razek AAKA, El Badrawy MK, Alnaghy E. Interstitial lung fibrosis imaging ' 'reporting and data system: what radiologist wants to know? J Comput ' 'Assist Tomogr. 2020;44:656–66.', 'journal-title': 'J Comput Assist Tomogr'}, { 'key': '5773_CR38', 'doi-asserted-by': 'publisher', 'unstructured': 'Ip A, Ahn J, Goldberg SL. Hydroxychloroquine in the treatment of ' 'outpatients with mildly symptomatic COVID-19: a multi-center ' 'observational study dataset. 2020. ' 'Synapse:!Synapse:syn22909530/files/.', 'DOI': '10.7303/syn22909530'}], 'container-title': 'BMC Infectious Diseases', 'original-title': [], 'language': 'en', 'link': [ { 'URL': '', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': '', 'content-type': 'text/html', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': '', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2021, 1, 14]], 'date-time': '2021-01-14T11:05:00Z', 'timestamp': 1610622300000}, 'score': 1, 'resource': { 'primary': { 'URL': ''}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2021, 1, 14]]}, 'references-count': 38, 'journal-issue': {'issue': '1', 'published-print': {'date-parts': [[2021, 12]]}}, 'alternative-id': ['5773'], 'URL': '', 'relation': {}, 'ISSN': ['1471-2334'], 'subject': ['Infectious Diseases'], 'container-title-short': 'BMC Infect Dis', 'published': {'date-parts': [[2021, 1, 14]]}, 'assertion': [ { 'value': '25 August 2020', 'order': 1, 'name': 'received', 'label': 'Received', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '6 January 2021', 'order': 2, 'name': 'accepted', 'label': 'Accepted', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '14 January 2021', 'order': 3, 'name': 'first_online', 'label': 'First Online', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': 'Institutional Review Board approval was obtained for access to the prospective ' 'observational database (Hackensack Meridian Health under Study# Pro2020–0342). ' 'The requirement for patient informed consent, verbal or written, and HIPAA ' 'aurthorization was waived by the IRB as this project represented a ' 'non-interventional study utilizing routinely collected data for secondary ' 'research purposes.', 'order': 1, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Ethics approval and consent to participate'}}, { 'value': 'Not applicable.', 'order': 2, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Consent for publication'}}, { 'value': '<i>Potential conflicts of interest</i>: AHG reports being a study investigator ' 'for Genentech-Hoffman La Roche, during the conduct of the study; research ' 'funding as study investigator from Acerta, AstraZeneca, Celgene, Kite Pharma, ' 'Elsevier’s PracticeUpdate Oncology, Gilead, Medscape, MJH Associates, OncLive ' 'Peer Exchange, Physicians Education Resource, and Xcenda, outside the submitted ' 'work, and research funding as a study investigator for Constellation, Infinity, ' 'Infinity Verastem, Janssen, Karyopharm, and Pharmacyclics, outside of the ' 'submitted work.<i>Potential conflicts of interest:</i> EH report consulting for ' 'Regional Cancer Care Associates and Hackensack Meridian Health, outside the ' 'submitted work.<i>Potential conflicts of interest:</i> ALP and SLG report ' 'having equity ownership in COTA, outside the submitted work.<i>No conflicts of ' 'interest:</i> AI, JA, YZ, BAS, UB, MM, ISS, JPU, DMW, RP, RLS, MGP, SLC, FJC, ' 'AGC, BLP, DR, GEM, MPE, KLZ, and PM.', 'order': 3, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Competing interests'}}], 'article-number': '72'}
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