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All Studies   Meta Analysis    Recent:   

Hydroxychloroquine for SARS-CoV-2 positive patients quarantined at home: The first interim analysis of a remotely conducted randomized clinical trial

Amaravadi et al., medRxiv, doi:10.1101/2021.02.22.21252228
Feb 2021  
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Not reaching lowest sy.. 60% Improvement Relative Risk Not reaching lowes.. (b) 50% Time to first occurrence of.. 43% Time to release from qu.. 27% primary HCQ  Amaravadi et al.  EARLY TREATMENT  DB RCT Is early treatment with HCQ beneficial for COVID-19? Double-blind RCT 29 patients in the USA (April - July 2020) Improved recovery with HCQ (not stat. sig., p=0.13) c19hcq.org Amaravadi et al., medRxiv, February 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 411 studies, recognized in 46 countries.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,300+ studies for 75 treatments. c19hcq.org
Tiny early-terminated 34 patient RCT for outpatient treatment showing faster recovery with treatment (not statistically significant). All patients recovered (3 control patients recovered after crossover to the treatment arm) - as per protocol mid-recovery results have priority. There was no mortality and only one hospitalization on day 0 before treatment. There were no severe adverse events.
risk of not reaching lowest symptom score at day 7 mid-recovery, 60.0% lower, RR 0.40, p = 0.13, treatment 3 of 15 (20.0%), control 6 of 12 (50.0%), NNT 3.3.
risk of not reaching lowest symptom score at day 5 mid-recovery, 50.0% lower, RR 0.50, p = 0.13, treatment 5 of 15 (33.3%), control 8 of 12 (66.7%), NNT 3.0.
relative time to first occurrence of lowest symptom score, 42.9% lower, relative time 0.57, p = 0.38, treatment median 4.0 IQR 13.0 n=15, control median 7.0 IQR 10.0 n=12.
relative time to release from quarantine, 27.3% lower, relative time 0.73, p = 0.46, treatment median 8.0 IQR 15.0 n=16, control median 11.0 IQR 14.0 n=13, primary outcome.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Amaravadi et al., 26 Feb 2021, Double Blind Randomized Controlled Trial, USA, preprint, 20 authors, study period 15 April, 2020 - 14 July, 2020, dosage 400mg bid days 1-14.
This PaperHCQAll
Hydroxychloroquine for SARS-CoV-2 positive patients quarantined at home: The first interim analysis of a remotely conducted randomized clinical trial
MD Ravi K Amaravadi, Lydia Giles, Mary Carberry, MD PhD Matthew C Hyman, MD Ian Frank, MD Sunita D Nasta, Jennifer Walsh, E Paul Wileyto, PhD Phyllis Gimotty, MD PhD Michael Milone, BA Edith M Teng, MBS Niraj J Vyas, MD Steve Balian, BA Jonathan A Kolansky, BS Nabil M Abdulhay, BS BSN Shaun K Mcgovern, BA Sarah Gamblin, BS Olivia Doran, BA Paul L Callahan, MD MPhil Benjamin S Abella
doi:10.1101/2021.02.22.21252228
Background Older patients are at risk of increased morbidity and mortality from COVID-19 disease due to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). There are few effective treatments for outpatients with COVID-19. Objective To evaluate the efficacy of hydroxychloroquine to reduce time in quarantine for symptomatic ≥40 years-old COVID-19 patients. Design A randomized, double-blind, placebo-controlled clinical trial. Setting Outpatients with polymerase chain reaction confirmed COVID-19 at a University of Pennsylvania affiliated testing center between April 15, 2020 and, July 14, 2020. Participants Out of 5511 SARS-CoV-2 positive patients, 1072 met initial eligibility criteria for telephonebased recruitment, but only 34 subjects were able to be randomized. Interventions Hydroxychloroquine 400 mg per twice daily (n=17) or matching placebo (n=17), taken orally for up to 14 days. Measurements The primary outcome was the time to release from quarantine. Secondary outcomes included the participant-reported secondary infection of co-inhabitants, hospitalization, treatment-related adverse events, time to symptom improvement, and incidence of cardiac arrhythmia. Results .
References
Alexander, Debono, Mammen, Iorio, Aryal et al., COVID-19 coronavirus research has overall low methodological quality thus far: case in point for chloroquine/hydroxychloroquine, J Clin Epidemiol, doi:10.1016/j.jclinepi.2020.04.016
Burton, Fort, Seoane, Hospitalization and Mortality among Black Patients and White Patients with Covid-19, N Engl J Med, doi:10.1056/NEJMsa2011686
Group, Horby, Mafham, Linsell, Bell et al., Effect of Hydroxychloroquine in Hospitalized Patients with Covid-19, N Engl J Med, doi:10.1056/NEJMoa2022926
Hwang, Shih, Cani, Group sequential designs using a family of type I error probability spending functions, Stat Med, doi:10.1002/sim.4780091207
Liu, Cao, Xu, Wang, Zhang et al., None
Mehra, Desai, Ruschitzka, Patel, RETRACTED: Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis, Lancet, doi:10.1016/S0140-6736(20)31180-6
Northwell, Barnaby, Becker, Chelico, Cohen et al., Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area, JAMA, doi:10.1001/jama.2020.6775
Nurchis, Pascucci, Sapienza, Villani, 'ambrosio et al., Impact of the Burden of COVID-19 in Italy: Results of Disability-Adjusted Life Years (DALYs) and Productivity Loss, Int J Environ Res Public Health, doi:10.3390/ijerph17124233
Richardson, Hirsch, Narasimhan, Crawford, Mcginn et al., the
Skipper, Pastick, Engen, Bangdiwala, Abassi et al., Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19: A Randomized Trial, Ann Intern Med, doi:10.7326/M20-4207
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There are few effective treatments for ' 'outpatients with ' 'COVID-19.</jats:p></jats:sec><jats:sec><jats:title>Objective</jats:title><jats:p>To evaluate ' 'the efficacy of hydroxychloroquine to reduce time in quarantine for symptomatic ≥40 years-old ' 'COVID-19 patients.</jats:p></jats:sec><jats:sec><jats:title>Design</jats:title><jats:p>A ' 'randomized, double-blind, placebo-controlled clinical ' 'trial.</jats:p></jats:sec><jats:sec><jats:title>Setting</jats:title><jats:p>Outpatients with ' 'polymerase chain reaction confirmed COVID-19 at a University of Pennsylvania affiliated ' 'testing center between April 15, 2020 and, July 14, ' '2020.</jats:p></jats:sec><jats:sec><jats:title>Participants</jats:title><jats:p>Out of 5511 ' 'SARS-CoV-2 positive patients, 1072 met initial eligibility criteria for telephone-based ' 'recruitment, but only 34 subjects were able to be ' 'randomized.</jats:p></jats:sec><jats:sec><jats:title>Interventions</jats:title><jats:p>Hydroxychloroquine ' '400 mg per twice daily (n=17) or matching placebo (n=17), taken orally for up to 14 ' 'days.</jats:p></jats:sec><jats:sec><jats:title>Measurements</jats:title><jats:p>The primary ' 'outcome was the time to release from quarantine. Secondary outcomes included the ' 'participant-reported secondary infection of co-inhabitants, hospitalization, ' 'treatment-related adverse events, time to symptom improvement, and incidence of cardiac ' 'arrhythmia.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>The median ' 'time to release from quarantine for HCQ-treated vs. placebo-treated participants was 8 days ' '(range 4-19 days) vs. 11 days (4-18 days); z-score +0.58, p=n.s. This did not meet the ' 'pre-specified criteria for early termination, however, this study was terminated early due to ' 'lack of feasibility. There was no mortality in either study ' 'arm.</jats:p></jats:sec><jats:sec><jats:title>Limitation</jats:title><jats:p>Since this study ' 'was terminated early due to a lack of feasibility, no conclusion can be made about the ' 'efficacy of hydroxychloroquine as a treatment for COVID-19 patients 40 years of age or older ' 'quarantined at ' 'home.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>The design of ' 'this remotely conducted study could guide testing of other more promising agents during the ' 'COVID-19 pandemic.</jats:p></jats:sec><jats:sec><jats:title>Trial ' 'registration</jats:title><jats:p><jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ' 'ext-link-type="uri" xlink:href="http://Clinicaltrials.gov">Clinicaltrials.gov</jats:ext-link> ' 'identifier: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ' 'ext-link-type="clintrialgov" ' 'xlink:href="NCT04329923">NCT04329923</jats:ext-link></jats:p></jats:sec>', 'DOI': '10.1101/2021.02.22.21252228', 'type': 'posted-content', 'created': {'date-parts': [[2021, 2, 26]], 'date-time': '2021-02-26T13:40:14Z', 'timestamp': 1614346814000}, 'source': 'Crossref', 'is-referenced-by-count': 2, 'title': 'Hydroxychloroquine for SARS-CoV-2 positive patients quarantined at home: The first interim ' 'analysis of a remotely conducted randomized clinical trial', 'prefix': '10.1101', 'author': [ {'given': 'Ravi K.', 'family': 'Amaravadi', 'sequence': 'first', 'affiliation': []}, {'given': 'Lydia', 'family': 'Giles', 'sequence': 'additional', 'affiliation': []}, {'given': 'Mary', 'family': 'Carberry', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0002-4050-6925', 'authenticated-orcid': False, 'given': 'Matthew C.', 'family': 'Hyman', 'sequence': 'additional', 'affiliation': []}, {'given': 'Ian', 'family': 'Frank', 'sequence': 'additional', 'affiliation': []}, {'given': 'Sunita D.', 'family': 'Nasta', 'sequence': 'additional', 'affiliation': []}, {'given': 'Jennifer', 'family': 'Walsh', 'sequence': 'additional', 'affiliation': []}, {'given': 'E. 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