Analgesics
Antiandrogens
Azvudine
Bromhexine
Budesonide
Colchicine
Conv. Plasma
Curcumin
Famotidine
Favipiravir
Fluvoxamine
Hydroxychlor..
Ivermectin
Lifestyle
Melatonin
Metformin
Minerals
Molnupiravir
Monoclonals
Naso/orophar..
Nigella Sativa
Nitazoxanide
Paxlovid
Quercetin
Remdesivir
Thermotherapy
Vitamins
More

Other
Feedback
Home
Top
Results
Abstract
All HCQ studies
Meta analysis
 
Feedback
Home
next
study
previous
study
c19hcq.org COVID-19 treatment researchHCQHCQ (more..)
Melatonin Meta
Metformin Meta
Azvudine Meta
Bromhexine Meta Molnupiravir Meta
Budesonide Meta
Colchicine Meta
Conv. Plasma Meta Nigella Sativa Meta
Curcumin Meta Nitazoxanide Meta
Famotidine Meta Paxlovid Meta
Favipiravir Meta Quercetin Meta
Fluvoxamine Meta Remdesivir Meta
Hydroxychlor.. Meta Thermotherapy Meta
Ivermectin Meta

All Studies   Meta Analysis    Recent:   

Pre-exposure prophylaxis with hydroxychloroquine for COVID-19: a double-blind, placebo-controlled randomized clinical trial

Grau-Pujol et al., Trials, doi:10.1186/s13063-021-05758-9
Sep 2020  
  Post
  Facebook
Share
  Source   PDF   All Studies   Meta AnalysisMeta
Case 11% Improvement Relative Risk HCQ  Grau-Pujol et al.  Prophylaxis  RCT Is pre-exposure prophylaxis with HCQ beneficial for COVID-19? RCT 269 patients in Spain (April - June 2020) Trial underpowered to detect differences c19hcq.org Grau-Pujol et al., Trials, September 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. c19hcq.org
Small PrEP RCT showing that PrEP with HCQ is safe at the dosage used. There were no deaths, hospitalizations, or serious adverse events.
The paper states: "Among all trial participants at the end of the first month (n=253), only one participant from the placebo arm (1/116, 0.8%), tested positive for SARS-CoV-2 PCR and for a SARS-CoV-2 serology test".
The abstract states: "only one participant in each group was diagnosed with COVID-19".
risk of case, 10.6% lower, RR 0.89, p = 1.00, treatment 1 of 142 (0.7%), control 1 of 127 (0.8%), NNT 1202.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Grau-Pujol et al., 21 Sep 2020, Randomized Controlled Trial, Spain, peer-reviewed, 22 authors, study period 4 April, 2020 - 12 June, 2020.
This PaperHCQAll
Pre-exposure prophylaxis with hydroxychloroquine for COVID-19: a double-blind, placebo-controlled randomized clinical trial
Berta Grau-Pujol, Daniel Camprubí-Ferrer, Helena Marti-Soler, Marc Fernández-Pardos, Clara Carreras-Abad, Maria Velasco-De Andrés, Elisabet Ferrer, Magdalena Muelas-Fernandez, Sophie Jullien, Giuseppe Barilaro, Sara Ajanovic, Isabel Vera, Laura Moreno, Eva Gonzalez-Redondo, Núria Cortes-Serra, Montserrat Roldán, Ana Artes-De Arcos, Isabel Mur, Pere Domingo, Felipe Garcia, Caterina Guinovart, Jose Muñoz
Trials, doi:10.1186/s13063-021-05758-9
Background: Pre-exposure prophylaxis (PrEP) is a promising strategy to break COVID-19 transmission. Although hydroxychloroquine was evaluated for treatment and post-exposure prophylaxis, it is not evaluated for COVID-19 PrEP yet. The aim of this study was to evaluate the efficacy and safety of PrEP with hydroxychloroquine against placebo in healthcare workers at high risk of SARS-CoV-2 infection during an epidemic period. Methods: We conducted a double-blind placebo-controlled randomized clinical trial in three hospitals in Barcelona, Spain. From 350 adult healthcare workers screened, we included 269 participants with no active or past SARS-CoV-2 infection (determined by a negative nasopharyngeal SARS-CoV-2 PCR and a negative serology against SARS-CoV-2). Participants allocated in the intervention arm (PrEP) received 400 mg of hydroxychloroquine daily for the first four consecutive days and subsequently, 400 mg weekly during the study period. Participants in the control group followed the same treatment schedule with placebo tablets. Results: 52.8% (142/269) of participants were in the hydroxychloroquine arm and 47.2% (127/269) in the placebo arm. Given the national epidemic incidence decay, only one participant in each group was diagnosed with COVID-19. The trial was stopped due to futility and our study design was deemed underpowered to evaluate any benefit regarding PrEP efficacy. Both groups showed a similar proportion of participants experiencing at least one adverse event (AE) (p=0.548). No serious AEs were reported. Almost all AEs (96.4%, 106/110) were mild. Only mild gastrointestinal symptoms were significantly higher in the hydroxychloroquine arm compared to the placebo arm (27.4% (39/142) vs 15.7% (20/127), p=0.041).
Abbreviations Supplementary Information The online version contains supplementary material available at https://doi. org/10.1186/s13063-021-05758-9. Additional file 1. Authors' contributions Grau-Pujol and Camprubí-Ferrer contributed equally to this manuscript. Concept and design: Muñoz, Grau-Pujol, Camprubí-Ferrer, Marti-Soler, Fernández-Pardos, Guinovart, Garcia. Acquisition or interpretation of data: Grau-Pujol, Camprubí-Ferrer, Martí-Soler, Carerras-Abad, Muelas-Fernández, Jullien, Barilaro, Ajanovic, Ferrer, Vera, Moreno, González-Redondo, Roldán, Artes-de Arcos, Mur. Drafting of the manuscript: Grau-Pujol, Camprubí-Ferrer. Critical revision: Muñoz, Camprubí-Ferrer, Grau-Pujol, Jullien, Carreras-Abad, Domingo, Mur, Barilaro, Guinovart, Martí-Soler. Statistical analysis: Martí-Soler, Grau-Pujol, Camprubí-Ferrer, Muñoz. Obtained funding: Muñoz. Administrative or technical support: Fernández-Pardos, Grau-Pujol, Velasco-de Andrés, Cortes-Serra, Ferrer, Vera, González-Redondo, Moreno, Roldán, Artes-de Arcos. Supervision: Muñoz. The authors read and approved the final manuscript. Declarations Ethics approval and consent to participate This trial was approved by the Drug Research Ethics Committee of the Hospital Clinic of Barcelona (CEIm), Barcelona, Spain, and the Spanish Agency of Medicines and Medical Products (AEMPS). The study was performed according to the Declaration of Helsinki (version of Fortaleza, Brazil, October 2013), current ICH-GCP guidelines, and all..
References
Abarientos, Sperber, Shapiro, Aronow, Chao et al., Hydroxychloroquine in systemic lupus erythematosus and rheumatoid arthritis and its safety in pregnancy, Expert Opin Drug Saf, doi:10.1517/14740338.2011.566555
Borba, Val, Sampaio, Alexandre, Melo et al., Effect of high vs low doses of chloroquine diphosphate as adjunctive therapy for patients hospitalized with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Infection: A Randomized Clinical Trial, JAMA Netw Open, doi:10.1001/jamanetworkopen.2020.8857
Boulware, Pullen, Bangdiwala, Pastick, Lofgren et al., A randomized trial of hydroxychloroquine as postexposure prophylaxis for COVID-19, N Engl J Med, doi:10.1056/NEJMoa2016638
Burke, Midgley, Dratch, Fenstersheib, Haupt et al., Active monitoring of persons exposed to patients with confirmed COVID-19 -United States, January-February 2020, MMWR Morb Mortal Wkly Rep, doi:10.15585/mmwr.mm6909e1
Chou, Evans, Hoverman, Sun, Dana et al., Preexposure Prophylaxis for the Prevention of HIV Infection: Evidence Report and Systematic Review for the US Preventive Services Task Force, JAMA, doi:10.1001/jama.2019.2591
Geleris, Sun, Platt, Zucker, Baldwin et al., Observational study of hydroxychloroquine in hospitalized patients with COVID-19, N Engl J Med, doi:10.1056/NEJMoa2012410
Grau-Pujol, Camprubí, Marti-Soler, Fernández-Pardos, Guinovart et al., Pre-exposure prophylaxis with hydroxychloroquine for high-risk healthcare workers during the COVID-19 pandemic: A structured summary of a study protocol for a multicentre, double-blind randomized controlled trial, Trials, doi:10.1186/s13063-020-04621-7
Lakatos, Lan, A comparison of sample size methods for the logrank statistic, Statistics in Medicine, doi:10.1002/sim.4780110205
Lim, Im, Cho, Bae, Klein et al., Pharmacokinetics of hydroxychloroquine and its clinical implications in chemoprophylaxis against malaria caused by Plasmodium vivax, Antimicrob Agents Chemother, doi:10.1128/AAC.00339-08
Liu, Cao, Xu, Wang, Zhang et al., Hydroxychloroquine, a less toxic derivative of chloroquine, is effective in inhibiting SARS-CoV-2 infection in vitro, Cell Discov, doi:10.1038/s41421-020-0156-0
Ortega, Ribes, Vidal, Rubio, Aguilar et al., Sevenmonth kinetics of SARS-CoV-2 antibodies and role of pre-existing antibodies to human coronaviruses, Nat Commun
Park, Kim, Yi, Lee, Na et al., Coronavirus disease outbreak in call center, South Korea, Emerg Infect Dis
Ponticelli, Moroni, Hydroxychloroquine in systemic lupus erythematosus (SLE), Expert Opin Drug Saf, doi:10.1080/14740338.2017.1269168
Rosenberg, Dufort, Udo, Wilberschied, Kumar et al., Association of treatment with hydroxychloroquine or azithromycin with inhospital mortality in patients with COVID-19 in New York State, JAMA, doi:10.1001/jama.2020.8630
Sallard, Belhadi, Lescure, Yazdanpanah, Peiffer-Smadja, Clinical trial protocols of repurposed prophylaxis for COVID-19: A review, Infect Dis Now, doi:10.1016/j.medmal.2020.09.013
Vincent, Bergeron, Benjannet, Erickson, Rollin et al., Chloroquine is a potent inhibitor of SARS coronavirus infection and spread, Virol J, doi:10.1186/1743-422X-2-69
Wang, Cao, Zhang, Yang, Liu et al., Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro, Cell Res, doi:10.1038/s41422-020-0282-0
Wolfe, Marmor, Rates and predictors of hydroxychloroquine retinal toxicity in patients with rheumatoid arthritis and systemic lupus erythematosus, Arthritis Care Res, doi:10.1002/acr.20133
Wright, Dhs, Walmsley, Hulme, Connor et al., Protecting Frontline Health Care Workers from COVID-19 with Hydroxychloroquine Pre-exposure Prophylaxis: A structured summary of a study protocol for a randomised placebo-controlled multisite trial in Toronto, Canada, Trials, doi:10.1186/s13063-020-04577-8
Yao, Ye, Zhang, Cui, Huang et al., In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Clin Infect Dis
Zhu, Zhang, Li, Yang, Song, A Novel Coronavirus from patients with pneumonia in China, 2019, N Engl J Med, doi:10.1056/NEJMoa2001017
{ 'indexed': { 'date-parts': [[2021, 11, 16]], 'date-time': '2021-11-16T10:12:12Z', 'timestamp': 1637057532222}, 'reference-count': 29, 'publisher': 'Springer Science and Business Media LLC', 'issue': '1', 'license': [ { 'start': { 'date-parts': [[2021, 11, 15]], 'date-time': '2021-11-15T00:00:00Z', 'timestamp': 1636934400000}, 'content-version': 'tdm', 'delay-in-days': 0, 'URL': 'https://creativecommons.org/licenses/by/4.0'}, { 'start': { 'date-parts': [[2021, 11, 15]], 'date-time': '2021-11-15T00:00:00Z', 'timestamp': 1636934400000}, 'content-version': 'vor', 'delay-in-days': 0, 'URL': 'https://creativecommons.org/licenses/by/4.0'}], 'funder': [{'name': 'ISGlobal'}, {'name': 'Laboratoris Rubió'}], 'content-domain': {'domain': ['link.springer.com'], 'crossmark-restriction': False}, 'short-container-title': ['Trials'], 'published-print': {'date-parts': [[2021, 12]]}, 'abstract': '<jats:title>Abstract</jats:title><jats:sec>\n' ' <jats:title>Background</jats:title>\n' ' <jats:p>Pre-exposure prophylaxis (PrEP) is a promising strategy to break ' 'COVID-19 transmission. Although hydroxychloroquine was evaluated for treatment and ' 'post-exposure prophylaxis, it is not evaluated for COVID-19 PrEP yet. The aim of this study ' 'was to evaluate the efficacy and safety of PrEP with hydroxychloroquine against placebo in ' 'healthcare workers at high risk of SARS-CoV-2 infection during an epidemic period.</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Methods</jats:title>\n' ' <jats:p>We conducted a double-blind placebo-controlled randomized clinical ' 'trial in three hospitals in Barcelona, Spain. From 350 adult healthcare workers screened, we ' 'included 269 participants with no active or past SARS-CoV-2 infection (determined by a ' 'negative nasopharyngeal SARS-CoV-2 PCR and a negative serology against SARS-CoV-2). ' 'Participants allocated in the intervention arm (PrEP) received 400\u2009mg of ' 'hydroxychloroquine daily for the first four consecutive days and subsequently, 400\u2009mg ' 'weekly during the study period. Participants in the control group followed the same treatment ' 'schedule with placebo tablets.</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Results</jats:title>\n' ' <jats:p>52.8% (142/269) of participants were in the hydroxychloroquine arm ' 'and 47.2% (127/269) in the placebo arm. Given the national epidemic incidence decay, only one ' 'participant in each group was diagnosed with COVID-19. The trial was stopped due to futility ' 'and our study design was deemed underpowered to evaluate any benefit regarding PrEP efficacy. ' 'Both groups showed a similar proportion of participants experiencing at least one adverse ' 'event (AE) (<jats:italic>p</jats:italic>=0.548). No serious AEs were reported. Almost all AEs ' '(96.4%, 106/110) were mild. Only mild gastrointestinal symptoms were significantly higher in ' 'the hydroxychloroquine arm compared to the placebo arm (27.4% (39/142) vs 15.7% (20/127), ' '<jats:italic>p</jats:italic>=0.041).</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Conclusions</jats:title>\n' ' <jats:p>Although the efficacy of PrEP with hydroxychloroquine for preventing ' 'COVID-19 could not be evaluated, our study showed that PrEP with hydroxychloroquine at low ' 'doses is safe.</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Trial registration</jats:title>\n' ' <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><jats:ext-link ' 'xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" ' 'xlink:href="https://clinicaltrials.gov/ct2/show/NCT04331834?term=NCT04331834&amp;draw=2&amp;rank=1">NCT04331834</jats:ext-link>. ' 'Registered on April 2, 2020.</jats:p>\n' ' </jats:sec>', 'DOI': '10.1186/s13063-021-05758-9', 'type': 'journal-article', 'created': { 'date-parts': [[2021, 11, 15]], 'date-time': '2021-11-15T12:03:01Z', 'timestamp': 1636977781000}, 'update-policy': 'http://dx.doi.org/10.1007/springer_crossmark_policy', 'source': 'Crossref', 'is-referenced-by-count': 0, 'title': [ 'Pre-exposure prophylaxis with hydroxychloroquine for COVID-19: a double-blind, ' 'placebo-controlled randomized clinical trial'], 'prefix': '10.1186', 'volume': '22', 'author': [ { 'ORCID': 'http://orcid.org/0000-0002-7320-0965', 'authenticated-orcid': False, 'given': 'Berta', 'family': 'Grau-Pujol', 'sequence': 'first', 'affiliation': []}, {'given': 'Daniel', 'family': 'Camprubí-Ferrer', 'sequence': 'additional', 'affiliation': []}, {'given': 'Helena', 'family': 'Marti-Soler', 'sequence': 'additional', 'affiliation': []}, {'given': 'Marc', 'family': 'Fernández-Pardos', 'sequence': 'additional', 'affiliation': []}, {'given': 'Clara', 'family': 'Carreras-Abad', 'sequence': 'additional', 'affiliation': []}, {'given': 'Maria Velasco-de', 'family': 'Andrés', 'sequence': 'additional', 'affiliation': []}, {'given': 'Elisabet', 'family': 'Ferrer', 'sequence': 'additional', 'affiliation': []}, { 'given': 'Magdalena', 'family': 'Muelas-Fernandez', 'sequence': 'additional', 'affiliation': []}, {'given': 'Sophie', 'family': 'Jullien', 'sequence': 'additional', 'affiliation': []}, {'given': 'Giuseppe', 'family': 'Barilaro', 'sequence': 'additional', 'affiliation': []}, {'given': 'Sara', 'family': 'Ajanovic', 'sequence': 'additional', 'affiliation': []}, {'given': 'Isabel', 'family': 'Vera', 'sequence': 'additional', 'affiliation': []}, {'given': 'Laura', 'family': 'Moreno', 'sequence': 'additional', 'affiliation': []}, {'given': 'Eva', 'family': 'Gonzalez-Redondo', 'sequence': 'additional', 'affiliation': []}, {'given': 'Núria', 'family': 'Cortes-Serra', 'sequence': 'additional', 'affiliation': []}, {'given': 'Montserrat', 'family': 'Roldán', 'sequence': 'additional', 'affiliation': []}, {'given': 'Ana Artes-de', 'family': 'Arcos', 'sequence': 'additional', 'affiliation': []}, {'given': 'Isabel', 'family': 'Mur', 'sequence': 'additional', 'affiliation': []}, {'given': 'Pere', 'family': 'Domingo', 'sequence': 'additional', 'affiliation': []}, {'given': 'Felipe', 'family': 'Garcia', 'sequence': 'additional', 'affiliation': []}, {'given': 'Caterina', 'family': 'Guinovart', 'sequence': 'additional', 'affiliation': []}, {'given': 'Jose', 'family': 'Muñoz', 'sequence': 'additional', 'affiliation': []}], 'member': '297', 'published-online': {'date-parts': [[2021, 11, 15]]}, 'reference': [ { 'issue': '8', 'key': '5758_CR1', 'doi-asserted-by': 'publisher', 'first-page': '727', 'DOI': '10.1056/NEJMoa2001017', 'volume': '382', 'author': 'N Zhu', 'year': '2020', 'unstructured': 'Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, et al. A Novel Coronavirus ' 'from patients with pneumonia in China, 2019. N Engl J Med. ' '2020;382(8):727–33. https://doi.org/10.1056/NEJMoa2001017.', 'journal-title': 'N Engl J Med.'}, { 'key': '5758_CR2', 'volume-title': 'Water, sanitation, hygiene, and waste management for the COVID-19 virus', 'year': '2020', 'unstructured': 'Water, sanitation, hygiene, and waste management for the COVID-19 virus. ' 'World Health Organization; 2020 23 April 2020. Contract No.: ' 'WHO/2019-nCoV/IPC_WASH/2020.3.'}, { 'key': '5758_CR3', 'volume-title': 'Rational use of personal protective equipment (PPE) for coronavirus ' 'disease (COVID-19)', 'year': '2020', 'unstructured': 'Rational use of personal protective equipment (PPE) for coronavirus ' 'disease (COVID-19). World Health Organization; 2020 19 March 2020. ' 'Contract No.: WHO/2019-nCoV/IPC PPE_use/2020.2.'}, { 'key': '5758_CR4', 'unstructured': 'Coronavirus (COVID-19) Centers for Disease Control and Prevention 2020 ' '[updated 29 June 2020. Available from: ' 'https://www.cdc.gov/coronavirus/2019-ncov/index.html.'}, { 'issue': '9', 'key': '5758_CR5', 'doi-asserted-by': 'publisher', 'first-page': '245', 'DOI': '10.15585/mmwr.mm6909e1', 'volume': '69', 'author': 'RM Burke', 'year': '2020', 'unstructured': 'Burke RM, Midgley CM, Dratch A, Fenstersheib M, Haupt T, Holshue M, et ' 'al. Active monitoring of persons exposed to patients with confirmed ' 'COVID-19 - United States, January-February 2020. MMWR Morb Mortal Wkly ' 'Rep. 2020;69(9):245–6. https://doi.org/10.15585/mmwr.mm6909e1.', 'journal-title': 'MMWR Morb Mortal Wkly Rep.'}, { 'issue': '8', 'key': '5758_CR6', 'doi-asserted-by': 'publisher', 'first-page': '1666', 'DOI': '10.3201/eid2608.201274', 'volume': '26', 'author': 'SY Park', 'year': '2020', 'unstructured': 'Park SY, Kim YM, Yi S, Lee S, Na BJ, Kim CB, et al. Coronavirus disease ' 'outbreak in call center, South Korea. Emerg Infect Dis. ' '2020;26(8):1666–70.', 'journal-title': 'Emerg Infect Dis'}, { 'key': '5758_CR7', 'volume-title': 'Report of the WHO-China Joint Mission on Coronavirus Disease 2019 ' '(COVID-19)', 'author': 'WHO', 'year': '2020', 'unstructured': 'WHO. Report of the WHO-China Joint Mission on Coronavirus Disease 2019 ' '(COVID-19). China: World Health Organization; 2020.'}, { 'key': '5758_CR8', 'volume-title': 'Coronavirus disease 2019 (COVID-19) in the EU/EEA and the UK - eighth ' 'update', 'year': '2020', 'unstructured': 'Coronavirus disease 2019 (COVID-19) in the EU/EEA and the UK - eighth ' 'update. European Centre for Disease prevention and Control; 2020.'}, { 'issue': '22', 'key': '5758_CR9', 'doi-asserted-by': 'publisher', 'first-page': '2214', 'DOI': '10.1001/jama.2019.2591', 'volume': '321', 'author': 'R Chou', 'year': '2019', 'unstructured': 'Chou R, Evans C, Hoverman A, Sun C, Dana T, Bougatsos C, et al. ' 'Preexposure Prophylaxis for the Prevention of HIV Infection: Evidence ' 'Report and Systematic Review for the US Preventive Services Task Force. ' 'JAMA. 2019;321(22):2214–30. https://doi.org/10.1001/jama.2019.2591.', 'journal-title': 'JAMA.'}, { 'key': '5758_CR10', 'unstructured': 'Clinicaltrials.gov: NIH US National Library of Medicine; [Available ' 'from: ' 'https://clinicaltrials.gov/ct2/results?cond=COVID&term=prophylaxis&cntry=&state=&city=&dist=.'}, { 'issue': '1', 'key': '5758_CR11', 'doi-asserted-by': 'publisher', 'first-page': '647', 'DOI': '10.1186/s13063-020-04577-8', 'volume': '21', 'author': 'JK Wright', 'year': '2020', 'unstructured': 'Wright JK, DHS T, Walmsley SL, Hulme J, O’Connor E, Snider C, et al. ' 'Protecting Frontline Health Care Workers from COVID-19 with ' 'Hydroxychloroquine Pre-exposure Prophylaxis: A structured summary of a ' 'study protocol for a randomised placebo-controlled multisite trial in ' 'Toronto, Canada. Trials. 2020;21(1):647. ' 'https://doi.org/10.1186/s13063-020-04577-8 PMID: 32665039; PMCID: ' 'PMC7359423.', 'journal-title': 'Trials'}, { 'issue': '1', 'key': '5758_CR12', 'doi-asserted-by': 'publisher', 'first-page': '7', 'DOI': '10.1016/j.medmal.2020.09.013', 'volume': '51', 'author': 'E Sallard', 'year': '2021', 'unstructured': 'Sallard E, Belhadi D, Lescure FX, Yazdanpanah Y, Peiffer-Smadja N. ' 'Clinical trial protocols of repurposed prophylaxis for COVID-19: A ' 'review. Infect Dis Now. 2021;51(1):7–13. ' 'https://doi.org/10.1016/j.medmal.2020.09.013 Epub 2020 Oct 3. PMID: ' '33022293; PMCID: PMC7532748.', 'journal-title': 'Infect Dis Now'}, { 'issue': '1', 'key': '5758_CR13', 'doi-asserted-by': 'publisher', 'first-page': '69', 'DOI': '10.1186/1743-422X-2-69', 'volume': '2', 'author': 'MJ Vincent', 'year': '2005', 'unstructured': 'Vincent MJ, Bergeron E, Benjannet S, Erickson BR, Rollin PE, Ksiazek TG, ' 'et al. Chloroquine is a potent inhibitor of SARS coronavirus infection ' 'and spread. Virol J. 2005;2(1):69. ' 'https://doi.org/10.1186/1743-422X-2-69.', 'journal-title': 'Virol J.'}, { 'issue': '3', 'key': '5758_CR14', 'doi-asserted-by': 'publisher', 'first-page': '269', 'DOI': '10.1038/s41422-020-0282-0', 'volume': '30', 'author': 'M Wang', 'year': '2020', 'unstructured': 'Wang M, Cao R, Zhang L, Yang X, Liu J, Xu M, et al. Remdesivir and ' 'chloroquine effectively inhibit the recently emerged novel coronavirus ' '(2019-nCoV) in vitro. Cell Res. 2020;30(3):269–71. ' 'https://doi.org/10.1038/s41422-020-0282-0.', 'journal-title': 'Cell Res.'}, { 'issue': '1', 'key': '5758_CR15', 'doi-asserted-by': 'publisher', 'first-page': '16', 'DOI': '10.1038/s41421-020-0156-0', 'volume': '6', 'author': 'J Liu', 'year': '2020', 'unstructured': 'Liu J, Cao R, Xu M, Wang X, Zhang H, Hu H, et al. Hydroxychloroquine, a ' 'less toxic derivative of chloroquine, is effective in inhibiting ' 'SARS-CoV-2 infection in vitro. Cell Discov. 2020;6(1):16. ' 'https://doi.org/10.1038/s41421-020-0156-0.', 'journal-title': 'Cell Discov.'}, { 'issue': '15', 'key': '5758_CR16', 'doi-asserted-by': 'publisher', 'first-page': '732', 'DOI': '10.1093/cid/ciaa237', 'volume': '71', 'author': 'X Yao', 'year': '2020', 'unstructured': 'Yao X, Ye F, Zhang M, Cui C, Huang B, Niu P, et al. In Vitro Antiviral ' 'Activity and Projection of Optimized Dosing Design of Hydroxychloroquine ' 'for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 ' '(SARS-CoV-2). Clin Infect Dis. 2020;71(15):732–9.', 'journal-title': 'Clin Infect Dis'}, { 'issue': '1', 'key': '5758_CR17', 'doi-asserted-by': 'publisher', 'first-page': '688', 'DOI': '10.1186/s13063-020-04621-7', 'volume': '21', 'author': 'B Grau-Pujol', 'year': '2020', 'unstructured': 'Grau-Pujol B, Camprubí D, Marti-Soler H, Fernández-Pardos M, Guinovart ' 'C, Muñoz J. Pre-exposure prophylaxis with hydroxychloroquine for ' 'high-risk healthcare workers during the COVID-19 pandemic: A structured ' 'summary of a study protocol for a multicentre, double-blind randomized ' 'controlled trial. Trials. 2020;21(1):688. ' 'https://doi.org/10.1186/s13063-020-04621-7 PMID: 32727613; PMCID: ' 'PMC7388426.', 'journal-title': 'Trials'}, { 'issue': '2', 'key': '5758_CR18', 'doi-asserted-by': 'publisher', 'first-page': '179', 'DOI': '10.1002/sim.4780110205', 'volume': '11', 'author': 'E Lakatos', 'year': '1992', 'unstructured': 'Lakatos E, Lan KK. A comparison of sample size methods for the logrank ' 'statistic. Statistics in Medicine. 1992;11(2):179–91. ' 'https://doi.org/10.1002/sim.4780110205.', 'journal-title': 'Statistics in Medicine.'}, { 'key': '5758_CR19', 'volume-title': 'A language and environment for statistical computing. Vienna, austria', 'year': '2019', 'unstructured': 'A language and environment for statistical computing. Vienna, austria: R ' 'Core Team, R Foundation for Statistical Computing; 2019 [Available from: ' 'https://www.R-project.org/.).'}, { 'issue': '1', 'key': '5758_CR20', 'doi-asserted-by': 'publisher', 'first-page': '4740', 'DOI': '10.1038/s41467-021-24979-9', 'volume': '12', 'author': 'N Ortega', 'year': '2021', 'unstructured': 'Ortega N, Ribes M, Vidal M, Rubio R, Aguilar R, Williams S, et al. ' 'Seven-month kinetics of SARS-CoV-2 antibodies and role of pre-existing ' 'antibodies to human coronaviruses. Nat Commun. 2021;12(1):4740.', 'journal-title': 'Nat Commun'}, { 'issue': '6', 'key': '5758_CR21', 'doi-asserted-by': 'publisher', 'first-page': '517', 'DOI': '10.1056/NEJMoa2016638', 'volume': '383', 'author': 'DR Boulware', 'year': '2020', 'unstructured': 'Boulware DR, Pullen MF, Bangdiwala AS, Pastick KA, Lofgren SM, Okafor ' 'EC, et al. A randomized trial of hydroxychloroquine as postexposure ' 'prophylaxis for COVID-19. N Engl J Med. 2020;383(6):517–25. ' 'https://doi.org/10.1056/NEJMoa2016638.', 'journal-title': 'N Engl J Med.'}, { 'issue': '25', 'key': '5758_CR22', 'doi-asserted-by': 'publisher', 'first-page': '2411', 'DOI': '10.1056/NEJMoa2012410', 'volume': '382', 'author': 'J Geleris', 'year': '2020', 'unstructured': 'Geleris J, Sun Y, Platt J, Zucker J, Baldwin M, Hripcsak G, et al. ' 'Observational study of hydroxychloroquine in hospitalized patients with ' 'COVID-19. N Engl J Med. 2020;382(25):2411–8. ' 'https://doi.org/10.1056/NEJMoa2012410.', 'journal-title': 'N Engl J Med.'}, { 'issue': '24', 'key': '5758_CR23', 'doi-asserted-by': 'publisher', 'first-page': '2493', 'DOI': '10.1001/jama.2020.8630', 'volume': '323', 'author': 'ES Rosenberg', 'year': '2020', 'unstructured': 'Rosenberg ES, Dufort EM, Udo T, Wilberschied LA, Kumar J, Tesoriero J, ' 'et al. Association of treatment with hydroxychloroquine or azithromycin ' 'with in-hospital mortality in patients with COVID-19 in New York State. ' 'JAMA. 2020;323(24):2493–502. https://doi.org/10.1001/jama.2020.8630.', 'journal-title': 'JAMA.'}, { 'issue': '4', 'key': '5758_CR24', 'doi-asserted-by': 'publisher', 'first-page': 'e208857', 'DOI': '10.1001/jamanetworkopen.2020.8857', 'volume': '3', 'author': 'MGS Borba', 'year': '2020', 'unstructured': 'Borba MGS, Val FFA, Sampaio VS, Alexandre MAA, Melo GC, Brito M, et al. ' 'Effect of high vs low doses of chloroquine diphosphate as adjunctive ' 'therapy for patients hospitalized with severe acute respiratory syndrome ' 'coronavirus 2 (SARS-CoV-2) Infection: A Randomized Clinical Trial. JAMA ' 'Netw Open. 2020;3(4):e208857. ' 'https://doi.org/10.1001/jamanetworkopen.2020.8857.', 'journal-title': 'JAMA Netw Open.'}, { 'issue': '4', 'key': '5758_CR25', 'doi-asserted-by': 'publisher', 'first-page': '1468', 'DOI': '10.1128/AAC.00339-08', 'volume': '53', 'author': 'HS Lim', 'year': '2009', 'unstructured': 'Lim HS, Im JS, Cho JY, Bae KS, Klein TA, Yeom JS, et al. ' 'Pharmacokinetics of hydroxychloroquine and its clinical implications in ' 'chemoprophylaxis against malaria caused by Plasmodium vivax. Antimicrob ' 'Agents Chemother. 2009;53(4):1468–75. ' 'https://doi.org/10.1128/AAC.00339-08.', 'journal-title': 'Antimicrob Agents Chemother.'}, { 'issue': '6', 'key': '5758_CR26', 'doi-asserted-by': 'publisher', 'first-page': '775', 'DOI': '10.1002/acr.20133', 'volume': '62', 'author': 'F Wolfe', 'year': '2010', 'unstructured': 'Wolfe F, Marmor MF. Rates and predictors of hydroxychloroquine retinal ' 'toxicity in patients with rheumatoid arthritis and systemic lupus ' 'erythematosus. Arthritis Care Res. 2010;62(6):775–84. ' 'https://doi.org/10.1002/acr.20133.', 'journal-title': 'Arthritis Care Res.'}, { 'issue': '5', 'key': '5758_CR27', 'doi-asserted-by': 'publisher', 'first-page': '705', 'DOI': '10.1517/14740338.2011.566555', 'volume': '10', 'author': 'C Abarientos', 'year': '2011', 'unstructured': 'Abarientos C, Sperber K, Shapiro DL, Aronow WS, Chao CP, Ash JY. ' 'Hydroxychloroquine in systemic lupus erythematosus and rheumatoid ' 'arthritis and its safety in pregnancy. Expert Opin Drug Saf. ' '2011;10(5):705–14. https://doi.org/10.1517/14740338.2011.566555.', 'journal-title': 'Expert Opin Drug Saf.'}, { 'issue': '3', 'key': '5758_CR28', 'doi-asserted-by': 'publisher', 'first-page': '411', 'DOI': '10.1080/14740338.2017.1269168', 'volume': '16', 'author': 'C Ponticelli', 'year': '2017', 'unstructured': 'Ponticelli C, Moroni G. Hydroxychloroquine in systemic lupus ' 'erythematosus (SLE). Expert Opin Drug Saf. 2017;16(3):411–9. ' 'https://doi.org/10.1080/14740338.2017.1269168.', 'journal-title': 'Expert Opin Drug Saf.'}, { 'key': '5758_CR29', 'volume-title': 'Situación y evolución de la pandemia de COVID-19 en España Spain', 'year': '2020', 'unstructured': 'Situación y evolución de la pandemia de COVID-19 en España Spain: Centro ' 'Nacional de Epidemiología; 2020 [Available from: ' 'https://cnecovid.isciii.es/covid19/#ccaa.'}], 'container-title': ['Trials'], 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://link.springer.com/content/pdf/10.1186/s13063-021-05758-9.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://link.springer.com/article/10.1186/s13063-021-05758-9/fulltext.html', 'content-type': 'text/html', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://link.springer.com/content/pdf/10.1186/s13063-021-05758-9.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2021, 11, 15]], 'date-time': '2021-11-15T12:03:40Z', 'timestamp': 1636977820000}, 'score': 1, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2021, 11, 15]]}, 'references-count': 29, 'journal-issue': {'issue': '1', 'published-print': {'date-parts': [[2021, 12]]}}, 'alternative-id': ['5758'], 'URL': 'http://dx.doi.org/10.1186/s13063-021-05758-9', 'relation': {}, 'ISSN': ['1745-6215'], 'issn-type': [{'value': '1745-6215', 'type': 'electronic'}], 'subject': ['Pharmacology (medical)', 'Medicine (miscellaneous)'], 'published': {'date-parts': [[2021, 11, 15]]}, 'assertion': [ { 'value': '23 March 2021', 'order': 1, 'name': 'received', 'label': 'Received', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '25 October 2021', 'order': 2, 'name': 'accepted', 'label': 'Accepted', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '15 November 2021', 'order': 3, 'name': 'first_online', 'label': 'First Online', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, {'order': 1, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Declarations'}}, { 'value': 'This trial was approved by the Drug Research Ethics Committee of the Hospital ' 'Clinic of Barcelona (CEIm), Barcelona, Spain, and the Spanish Agency of ' 'Medicines and Medical Products (AEMPS).The study was performed according to the ' 'Declaration of Helsinki (version of Fortaleza, Brazil, October 2013), current ' 'ICH-GCP guidelines, and all applicable national and local regulatory ' 'requirements (Spanish Royal Decree 1090/2015).Informed consent was signed by ' 'all participants before their inclusion in the study. Participation in this ' 'study was voluntary, and under no circumstances the clinical management of the ' 'participants was affected by the decision to participate or not in the study. ' 'The participant was free to withdraw at any time of the study.', 'order': 2, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Ethics approval and consent to participate'}}, { 'value': 'Not applicable.', 'order': 3, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Consent for publication'}}, { 'value': 'The authors declare that they have no competing interests.', 'order': 4, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Competing interests'}}], 'article-number': '808'}
Loading..
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.
  or use drag and drop   
Submit