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All Studies   Meta Analysis    Recent:   

Azithromycin and hydroxychloroquine in hospitalised patients with confirmed COVID-19–a randomised double-blinded placebo-controlled trial

Sivapalan et al., European Respiratory Journal, doi:10.1183/13993003.00752-2021, ProPAC-COVID, NCT04322396
Jun 2021  
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Mortality 92% Improvement Relative Risk ICU admission -22% Days alive and discharged.. -8% HCQ  ProPAC-COVID  LATE TREATMENT  DB RCT Is late treatment with HCQ beneficial for COVID-19? Double-blind RCT 117 patients in Denmark (April - December 2020) Lower mortality with HCQ (not stat. sig., p=0.32) c19hcq.org Sivapalan et al., European Respiratory.., Jun 2021 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 417 studies, recognized in 46 countries.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,800+ studies for 102 treatments. c19hcq.org
Early terminated late stage (8 days from onset, 59% on oxygen) RCT not showing statistically significant differences. NNF20SA0062834.
risk of death, 92.0% lower, RR 0.08, p = 0.32, treatment 1 of 61 (1.6%), control 2 of 56 (3.6%), adjusted per study.
risk of ICU admission, 22.4% higher, RR 1.22, p = 1.00, treatment 4 of 61 (6.6%), control 3 of 56 (5.4%).
relative days alive and discharged from hospital within 14 days (inverse), 8.4% worse, RR 1.08, p = 0.36, treatment 61, control 56, adjusted per study.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Sivapalan et al., 3 Jun 2021, Double Blind Randomized Controlled Trial, Denmark, peer-reviewed, 32 authors, study period 6 April, 2020 - 21 December, 2020, average treatment delay 8.0 days, trial NCT04322396 (history) (ProPAC-COVID).
This PaperHCQAll
Azithromycin and hydroxychloroquine in hospitalised patients with confirmed COVID-19-a randomised double-blinded placebo-controlled trial
MD, PhD Pradeesh Sivapalan, Charlotte Suppli Ulrik, MD Therese Sophie Lapperre, Dahlin Rasmus, Josefin Bojesen, Andrea Eklöf, Jon Torgny Browatzki, Vibeke Wilcke, Kjell Gottlieb, Julius Erik, Casper Håkansson, Oliver Tidemandsen, Howraman Tupper, Christina Marisa Meteran, Eva Bergsøe, Uffe Brøndum, Daniel Bech Bodtger, Sidse Graff Rasmussen, Lars Jensen, Alexander Pedersen, Helene Jordan, Christian Priemé, Ida Elisabeth Søborg, Dorthe Steffensen, Tobias Wirenfeldt Høgsberg, Martin Klausen, Peter Steen, Asger Lange, Muhzda Sverrild, Filip Krag Ghanizada, Tor Knop, Jens D Biering-Sørensen, Jens-Ulrik Staehr Lundgren, Jensen, MD, DMSc Charlotte Suppli Ulrik, PhD ; Rasmus, MD Dahlin Bojesen, PhD Josefin Eklöf, MD, PhD Andrea Browatzki, MD Jon Torgny Wilcke, PhD Vibeke Gottlieb, PhD Kjell Erik, MD Julius Håkansson, MD Casper Tidemandsen, MD Oliver Tupper, PhD Howraman Meteran, MD Christina Bergsøe, BSc Eva Brøndum, RN Uffe Bodtger, PhD ; Daniel, MD Bech Rasmussen, PhD ; Sidse, MD, PhD Graff Jensen, MD Lars Pedersen, PhD Alexander Jordan, BSc Helene Priemé, PhD Christian Søborg, MD, PhD Ida E Steffensen, PhD Dorthe Høgsberg, RN ; Tobias, MSc Wirenfeldt Klausen, PhD Martin Steen Frydland, PhD Peter Lange, MD, DMSc Asger Sverrild, MD, PhD; Muhzda Ghanizada, MD Filip Krag Knop, PhD Tor Biering-Sørensen, PhD, MPH Jens D Lundgren, MD, DMSc Jens-Ulrik Staehr Jensen, Senior Consultant, Research Associate Professor, MD, PhD. Jens-Ulrik Staehr Jensen, Suppli Ulrik, Andrea Bojesen, Howraman Djurhuus Tupper, Uffe Bergsøe, Steinholtz Christian, Daniel Bech Bødtger, Helene Pedersen, Steffensen, Sandbaek Dorthe, Martin Høgsberg, Peter Steen Frydland, Muzhda Sverrild, Jens-Ulrik Ghanizada, Staehr Jensen, Tobias Wirenfeldt Klausen, Jens D Lundgren, MD Andrea Browatzki Senior Consultant, Christian Laursen, Ulla Weinreich
doi:10.1183/13993003.00752-2021)
Azithromycin and hydroxychloroquine in hospitalised patients with confirmed COVID-19 -a randomised doubleblinded placebo-controlled trial by the ProPAC-COVID study group* *A complete list of members in the Proactive Protection with Azithromycin and hydroxy-Chloroquine in Hospitalised Patients With COVID-19 (ProPAC-COVID) Study Group is provided in Supplementary Appendix 3. The ProPAC-COVID study is an initiative by the independent research network COP:TRIN (www.coptrin.dk). The members of the writing group
For the secondary ordinary outcome, we will use a Wilcoxon rank sum test. The primary outcome uses an ordinal severity scale with 8 categories, analyzed using the proportional odds model. The key parameter of interest is the "common odds ratio," which quantifies the shift in the severity distribution resulting from treatment. For an efficacious treatment, an odds ratio greater than 1 quantifies an improvement in disease severity; a value of 2 indicates a bigger improvement than a value of 1.25. Sample size The power to avoid type II error is 80% (1-β) at a two-sided 5% significance level, using a t-test for the primary outcome, and a group-sequential design allowing for one interim analysis at half target recruitment. This provides a sample size of 226 subjects. All confidence intervals reported will be 95% confidence intervals. Analysis Software All analyses will be performed using SAS software version 9.4. DATA ANALYSIS Descriptive analyses -Baseline characteristics at study enrollment (defined as day 1). The following baseline characteristics of the study population will be summarized separately within each randomized group: Primary objective and outcome The primary outcome is "days alive and out of hospital (DAOH) within 14 days after recruitment" defined as the time from hospital discharge and days without hospitalization up to 14 days from recruitment where the patient is alive. Data for the primary outcome analysis will be presented as mean..
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{ 'indexed': {'date-parts': [[2024, 2, 28]], 'date-time': '2024-02-28T10:23:38Z', 'timestamp': 1709115818536}, 'reference-count': 34, 'publisher': 'European Respiratory Society (ERS)', 'issue': '1', 'license': [ { 'start': { 'date-parts': [[2021, 6, 3]], 'date-time': '2021-06-03T00:00:00Z', 'timestamp': 1622678400000}, 'content-version': 'vor', 'delay-in-days': 0, 'URL': 'http://creativecommons.org/licenses/by-nc/4.0/'}], 'funder': [ { 'DOI': '10.13039/501100009708', 'name': 'Novo Nordisk Fonden', 'doi-asserted-by': 'publisher', 'award': ['NNF20SA0062834']}], 'content-domain': {'domain': ['ersjournals.com'], 'crossmark-restriction': True}, 'published-print': {'date-parts': [[2022, 1]]}, 'abstract': '<jats:sec><jats:title>Background</jats:title><jats:p>Combining the antibiotic azithromycin ' 'and hydroxychloroquine induces airway immunomodulatory effects, with the latter also having ' '<jats:italic>in vitro</jats:italic> antiviral properties. This may improve outcomes in ' 'patients hospitalised for coronavirus disease 2019 ' '(COVID-19).</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Placebo-controlled ' 'double-blind randomised multicentre trial. Patients aged ≥18\u2005years, admitted to hospital ' 'for ≤48\u2005h (not intensive care) with a positive severe acute respiratory syndrome ' 'coronavirus 2 (SARS-CoV-2) reverse transcription PCR test were recruited. The intervention ' 'was 500\u2005mg daily azithromycin for 3\u2005days followed by 250\u2005mg daily azithromycin ' 'for 12\u2005days combined with 200\u2005mg twice-daily hydroxychloroquine for all 15\u2005' 'days. The control group received placebo/placebo. The primary outcome was days alive and ' 'discharged from hospital within 14\u2005days ' '(DAOH14).</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>After ' 'randomisation of 117 patients, at the first planned interim analysis, the data and safety ' 'monitoring board recommended stopping enrolment due to futility, based on pre-specified ' 'criteria. Consequently, the trial was terminated on 1 February 2021. 61 patients received the ' 'combined intervention and 56 patients received placebo. In the intervention group, patients ' 'had a median (interquartile range) 9.0 (3–11) DAOH14 <jats:italic>versus</jats:italic> 9.0 ' '(7–10) DAOH14 in the placebo group (p=0.90). The primary safety outcome, death from all ' 'causes on day 30, occurred for one patient in the intervention group ' '<jats:italic>versus</jats:italic> two patients receiving placebo (p=0.52), and readmittance ' 'or death within 30\u2005days occurred for nine patients in the intervention group ' '<jats:italic>versus</jats:italic> six patients receiving placebo ' '(p=0.57).</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>The ' 'combination of azithromycin and hydroxychloroquine did not improve survival or length of ' 'hospitalisation in patients with COVID-19.</jats:p></jats:sec>', 'DOI': '10.1183/13993003.00752-2021', 'type': 'journal-article', 'created': {'date-parts': [[2021, 6, 3]], 'date-time': '2021-06-03T14:47:55Z', 'timestamp': 1622731675000}, 'page': '2100752', 'update-policy': 'http://dx.doi.org/10.1183/ers-crossmark-policy', 'source': 'Crossref', 'is-referenced-by-count': 29, 'title': 'Azithromycin and hydroxychloroquine in hospitalised patients with 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Convalescent plasma ' 'use in the United States was inversely correlated with COVID-19 ' 'mortality: did convalescent plasma hesitancy cost lives? medRxiv 2021; ' 'preprint [https://doi.org/10.1101/2021.04.07.21255089].', 'DOI': '10.1101/2021.04.07.21255089'}, { 'key': '2022010601550744000_59.1.2100752.15', 'doi-asserted-by': 'crossref', 'first-page': '905', 'DOI': '10.1056/NEJMoa2033130', 'article-title': 'A neutralizing monoclonal antibody for hospitalized patients with ' 'Covid-19', 'volume': '384', 'year': '2021', 'journal-title': 'N Engl J Med'}, { 'key': '2022010601550744000_59.1.2100752.16', 'doi-asserted-by': 'publisher', 'DOI': '10.1056/NEJMoa2021436'}, { 'key': '2022010601550744000_59.1.2100752.17', 'doi-asserted-by': 'crossref', 'first-page': '1929', 'DOI': '10.1007/s40265-020-01421-w', 'article-title': 'Immune therapy, or antiviral therapy, or both for COVID-19: a ' 'systematic review', 'volume': '80', 'author': 'Cantini', 'year': '2020', 'journal-title': 'Drugs'}, { 'key': '2022010601550744000_59.1.2100752.18', 'doi-asserted-by': 'crossref', 'first-page': '513', 'DOI': '10.1186/s13063-020-04409-9', 'article-title': 'Proactive prophylaxis with azithromycin and hydroxychloroquine in ' 'hospitalised patients with COVID-19 (ProPAC-COVID): a structured ' 'summary of a study protocol for a randomised controlled trial', 'volume': '21', 'author': 'Sivapalan', 'year': '2020', 'journal-title': 'Trials'}, { 'key': '2022010601550744000_59.1.2100752.19', 'doi-asserted-by': 'crossref', 'first-page': '867', 'DOI': '10.1186/s13063-020-04795-0', 'article-title': 'Proactive prophylaxis with azithromycin and hydroxychloroquine in ' 'hospitalized patients with COVID-19 (ProPAC-COVID): a statistical ' 'analysis plan', 'volume': '21', 'author': 'Sivapalan', 'year': '2020', 'journal-title': 'Trials'}, { 'key': '2022010601550744000_59.1.2100752.20', 'doi-asserted-by': 'publisher', 'DOI': '10.1001/jama.2013.281053'}, { 'key': '2022010601550744000_59.1.2100752.21', 'doi-asserted-by': 'crossref', 'first-page': 'e906', 'DOI': '10.1161/CIRCULATIONAHA.120.047521', 'article-title': 'Considerations for drug interactions on QTc in exploratory COVID-19 ' 'treatment', 'volume': '141', 'author': 'Roden', 'year': '2020', 'journal-title': 'Circulation'}, { 'key': '2022010601550744000_59.1.2100752.22', 'doi-asserted-by': 'crossref', 'first-page': '1036', 'DOI': '10.1001/jamacardio.2020.1834', 'article-title': 'Risk of QT interval prolongation associated with use of ' 'hydroxychloroquine with or without concomitant azithromycin among ' 'hospitalized patients testing positive for coronavirus disease 2019 ' '(COVID-19)', 'volume': '5', 'author': 'Mercuro', 'year': '2020', 'journal-title': 'JAMA Cardiol'}, { 'key': '2022010601550744000_59.1.2100752.23', 'doi-asserted-by': 'crossref', 'first-page': '699', 'DOI': '10.1016/S2213-2600(19)30176-6', 'article-title': 'Eosinophil-guided corticosteroid therapy in patients admitted to ' 'hospital with COPD exacerbation (CORTICO-COP): a multicentre, ' 'randomised, controlled, open-label, non-inferiority trial', 'volume': '7', 'author': 'Sivapalan', 'year': '2019', 'journal-title': 'Lancet Respir Med'}, { 'key': '2022010601550744000_59.1.2100752.24', 'doi-asserted-by': 'crossref', 'first-page': '1948', 'DOI': '10.1001/jama.2020.19378', 'article-title': 'Effect of an emergency department care bundle on 30-day hospital ' 'discharge and survival among elderly patients with acute heart failure: ' 'the ELISABETH randomised clinical trial', 'volume': '324', 'author': 'Freund', 'year': '2020', 'journal-title': 'JAMA'}, { 'key': '2022010601550744000_59.1.2100752.25', 'doi-asserted-by': 'publisher', 'DOI': '10.1016/j.ahj.2011.08.003'}, { 'key': '2022010601550744000_59.1.2100752.26', 'doi-asserted-by': 'crossref', 'unstructured': 'Mehra MR , Desai SS , Ruschitzka F , et al. 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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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