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All Studies   Meta Analysis    Recent:   

Chloroquine diphosphate in two different dosages as adjunctive therapy of hospitalized patients with severe respiratory syndrome in the context of coronavirus (SARS-CoV-2) infection: Preliminary safety results of a randomized, double-blinded, phase IIb clinical trial (CloroCovid-19 Study)

Borba et al., JAMA Network Open, doi:10.1001/jamanetworkopen.2020.8857
Apr 2020  
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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
Comparison of typical CQ dosage with high dosage CQ (600mg CQ twice daily for 10 days), showing higher mortality with high dosage, OR 2.8 [0.9 - 8.5] when controlled by age in multivariate analysis.
Increased incidence of prolonged QT and death in high dose treatment arm. Patients >75 only enrolled in high dose arm, age of high dose arm significantly higher than low dose arm (p=0.02). Very sick at baseline, 46% in ICU, 89% on oxygen therapy (this information can be found in the preprint1).
Borba et al., 16 Apr 2020, peer-reviewed, mean age 51.1, 28 authors.
This PaperHCQAll
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
Mayla Gabriela Silva Borba, Fernando Fonseca Almeida Val, Vanderson Souza Sampaio, Marcia Almeida Araújo Alexandre, Gisely Cardoso Melo, MSc Marcelo Brito, Maria Paula Gomes Mourão, MSc José Diego Brito-Sousa, PhD; Djane Baía-Da-Silva, Marcus Vinitius Farias Guerra, Ludhmila Abrahão Hajjar, BSc Rosemary Costa Pinto, Antonio Alcirley Silva Balieiro, Antônio Guilherme Fonseca Pacheco, James Dean Oliveira Santos, Felipe Gomes Naveca, MSc Mariana Simão Xavier, André Machado Siqueira, MD Alexandre Schwarzbold, MD; Maurício Júlio Croda, Maurício Lacerda Nogueira, Gustavo Adolfo Sierra Romero, MD; Cor Quique Bassat, Cor Jesus Fontes, Bernardino Cláudio Albuquerque, Cláudio-Tadeu Daniel-Ribeiro, Wuelton Marcelo Monteiro, Marcus Vinícius Guimarães Lacerda
JAMA Network Open, doi:10.1001/jamanetworkopen.2020.8857
IMPORTANCE There is no specific antiviral therapy recommended for coronavirus disease 2019 (COVID-19). In vitro studies indicate that the antiviral effect of chloroquine diphosphate (CQ) requires a high concentration of the drug. OBJECTIVE To evaluate the safety and efficacy of 2 CQ dosages in patients with severe COVID-19. DESIGN, SETTING, AND PARTICIPANTS This parallel, double-masked, randomized, phase IIb clinical trial with 81 adult patients who were hospitalized with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection was conducted from March 23 to April 5, 2020, at a tertiary care facility in Manaus, Brazilian Amazon. INTERVENTIONS Patients were allocated to receive high-dosage CQ (ie, 600 mg CQ twice daily for 10 days) or low-dosage CQ (ie, 450 mg twice daily on day 1 and once daily for 4 days). MAIN OUTCOMES AND MEASURES Primary outcome was reduction in lethality by at least 50% in the high-dosage group compared with the low-dosage group. Data presented here refer primarily to safety and lethality outcomes during treatment on day 13. Secondary end points included participant clinical status, laboratory examinations, and electrocardiogram results. Outcomes will be presented to day 28. Viral respiratory secretion RNA detection was performed on days 0 and 4. RESULTS Out of a predefined sample size of 440 patients, 81 were enrolled (41 [50.6%] to highdosage group and 40 [49.4%] to low-dosage group). Enrolled patients had a mean (SD) age of 51.1 (13.9) years, and most (60 [75.3%]) were men. Older age (mean [SD] age, 54.7 [13.7] years vs 47.4 [13.3] years) and more heart disease (5 of 28 [17.9%] vs 0) were seen in the high-dose group. Viral RNA was detected in 31 of 40 (77.5%) and 31 of 41 (75.6%) patients in the low-dosage and highdosage groups, respectively. Lethality until day 13 was 39.0% in the high-dosage group (16 of 41) and 15.0% in the low-dosage group (6 of 40). The high-dosage group presented more instance of QTc interval greater than 500 milliseconds (7 of 37 [18.9%]) compared with the low-dosage group (4 of 36 [11.1%]). Respiratory secretion at day 4 was negative in only 6 of 27 patients (22.2%). CONCLUSIONS AND RELEVANCE The preliminary findings of this study suggest that the higher CQ dosage should not be recommended for critically ill patients with COVID-19 because of its potential (continued) Key Points Question How safe and effective are 2 different regimens of chloroquine diphosphate in the treatment of severe coronavirus disease 2019 (COVID-19)? Findings In this phase IIb randomized clinical trial of 81 patients with COVID-19, an unplanned interim analysis recommended by an independent data safety and monitoring board found that a higher dosage of chloroquine diphosphate for 10 days was associated with more toxic effects and lethality, particularly affecting QTc interval prolongation. The limited sample size did not allow the study to show any benefit overall regarding treatment efficacy. Meaning The..
Abbreviation: CK, creatine phosphokinase; CKMB, creatinine phosphokinase-MB; COVID-19, coronavirus disease 2019; QTcF, QT interval corrected by the Fridericia method. a Not all patients completed day 13 visit before this article was finalized. b Low-dosage group received chloroquine for 5 days (450 mg twice daily on the first day and 450 mg once daily for 4 days). c High-dosage group received chloroquine for 10 days (600 mg twice daily for 10 days). d Decreases in hemoglobin level of more than 3 g/dL or 30% or greater from baseline are shown. e Increases in creatinine serum levels of 30% or more from baseline are shown. f Serious adverse events related to the trial regimen were prolongation of the QTcF. Lethality among critically ill patients in the present study seemed to be even higher than among similar patients not receiving CQ in a large historical sample-size cohort of patients in Lombardy, Italy. 24 That could reflect the quality of intensive care units in both countries or the possible lack of or deleterious effect of CQ in such patients with COVID-19. The occurrence of myocarditis in our sample, with the confirmed QTcF prolongation, warrants caution regarding this drug's safety, particularly considering the eventual increase in fatal arrythmias, such as ventricular tachycardia. Strengths and Limitations This study had some strengths. It was double-masked; performed in a public hospital, which will manage most cases in countries like Brazil; compliant with good..
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'article-title': 'In vitro inhibition of severe acute respiratory syndrome coronavirus by ' 'chloroquine.', 'volume': '323', 'author': 'Keyaerts', 'year': '2004', 'journal-title': 'Biochem Biophys Res Commun'}, { 'issue': '3', 'key': 'zoi200372r10', 'first-page': '185', 'article-title': 'Expert consensus on chloroquine phosphate for the treatment of novel ' 'coronavirus pneumonia.', 'volume': '43', 'author': 'Multicenter collaboration group of Department of Science and Technology of ' 'Guangdong Province and Health Commission of Guangdong Province for chloroquine ' 'in the treatment of novel coronavirus pneumonia', 'year': '2020', 'journal-title': 'Zhonghua Jie He He Hu Xi Za Zhi'}, { 'issue': '3', 'key': 'zoi200372r11', 'doi-asserted-by': 'publisher', 'first-page': '269', 'DOI': '10.1038/s41422-020-0282-0', 'article-title': 'Remdesivir and chloroquine effectively inhibit the recently emerged ' 'novel coronavirus (2019-nCoV) in vitro.', 'volume': '30', 'author': 'Wang', 'year': '2020', 'journal-title': 'Cell Res'}, { 'issue': '1', 'key': 'zoi200372r12', 'doi-asserted-by': 'publisher', 'first-page': '72', 'DOI': '10.5582/bst.2020.01047', 'article-title': 'Breakthrough: Chloroquine phosphate has shown apparent efficacy in ' 'treatment of COVID-19 associated pneumonia in clinical studies.', 'volume': '14', 'author': 'Gao', 'year': '2020', 'journal-title': 'Biosci Trends'}, { 'key': 'zoi200372r13', 'doi-asserted-by': 'crossref', 'DOI': '10.1016/j.ijantimicag.2020.105949', 'article-title': 'Hydroxychloroquine and azithromycin as a treatment of COVID-19: results ' 'of an open-label non-randomized clinical trial.', 'author': 'Gautret', 'year': '2020', 'journal-title': 'Int J Antimicrob Agents'}, { 'issue': '4', 'key': 'zoi200372r14', 'doi-asserted-by': 'publisher', 'first-page': '1468', 'DOI': '10.1128/AAC.00339-08', 'article-title': 'Pharmacokinetics of hydroxychloroquine and its clinical implications in ' 'chemoprophylaxis against malaria caused by Plasmodium vivax.', 'volume': '53', 'author': 'Lim', 'year': '2009', 'journal-title': 'Antimicrob Agents Chemother'}, { 'issue': '1', 'key': 'zoi200372r16', 'doi-asserted-by': 'publisher', 'first-page': '89', 'DOI': '10.4103/0974-9233.106404', 'article-title': 'Delayed onset chloroquine retinopathy presenting 10 years after ' 'long-term usage of chloroquine.', 'volume': '20', 'author': 'Kazi', 'year': '2013', 'journal-title': 'Middle East Afr J Ophthalmol'}, { 'issue': '7', 'key': 'zoi200372r17', 'doi-asserted-by': 'publisher', 'first-page': '1321', 'DOI': '10.1016/S0161-6420(03)00409-3', 'article-title': 'The incidence of irreversible retinal toxicity in patients treated with ' 'hydroxychloroquine: a reappraisal.', 'volume': '110', 'author': 'Mavrikakis', 'year': '2003', 'journal-title': 'Ophthalmology'}, { 'issue': '5', 'key': 'zoi200372r18', 'first-page': '795', 'article-title': 'Chloroquine and QTc interval.', 'volume': '25', 'author': 'Silva', 'year': '2007', 'journal-title': 'Clin Exp Rheumatol'}, { 'issue': '2', 'key': 'zoi200372r19', 'doi-asserted-by': 'publisher', 'first-page': '203', 'DOI': '10.1099/0022-1317-4-2-203', 'article-title': 'Comparison of the antiviral activity in vitro of some non-steroidal ' 'anti-inflammatory drugs.', 'volume': '4', 'author': 'Inglot', 'year': '1969', 'journal-title': 'J Gen Virol'}, { 'issue': '6', 'key': 'zoi200372r20', 'doi-asserted-by': 'publisher', 'first-page': '3605', 'DOI': '10.1073/pnas.78.6.3605', 'article-title': 'Antihistaminics, local anesthetics, and other amines as antiviral ' 'agents.', 'volume': '78', 'author': 'Miller', 'year': '1981', 'journal-title': 'Proc Natl Acad Sci U S A'}, { 'key': 'zoi200372r21', 'doi-asserted-by': 'publisher', 'first-page': '18', 'DOI': '10.1186/1741-7015-8-18', 'article-title': 'CONSORT 2010 Statement: updated guidelines for reporting parallel group ' 'randomised trials.', 'volume': '8', 'author': 'Schulz', 'year': '2010', 'journal-title': 'BMC Med'}, { 'key': 'zoi200372r22', 'doi-asserted-by': 'crossref', 'DOI': '10.1056/NEJMc2005073', 'article-title': 'SARS-CoV-2 infection in children.', 'author': 'Lu', 'year': '2020', 'journal-title': 'N Engl J Med'}, { 'key': 'zoi200372r23', 'doi-asserted-by': 'publisher', 'first-page': 'm1091', 'DOI': '10.1136/bmj.m1091', 'article-title': 'Clinical characteristics of 113 deceased patients with coronavirus ' 'disease 2019: retrospective study.', 'volume': '368', 'author': 'Chen', 'year': '2020', 'journal-title': 'BMJ'}, { 'key': 'zoi200372r24', 'doi-asserted-by': 'crossref', 'DOI': '10.1001/jama.2020.5394', 'article-title': 'Baseline characteristics and outcomes of 1591 patients infected with ' 'SARS-CoV-2 admitted to ICUs of the Lombardy region, Italy.', 'author': 'Grasselli', 'year': '2020', 'journal-title': 'JAMA'}, { 'issue': '7', 'key': 'zoi200372r25', 'doi-asserted-by': 'publisher', 'first-page': '993', 'DOI': '10.1001/jamaoncol.2019.0684', 'article-title': 'Effect of gemcitabine and nab-paclitaxel with or without ' 'hydroxychloroquine on patients with advanced pancreatic cancer: a phase ' '2 randomized clinical trial.', 'volume': '5', 'author': 'Karasic', 'year': '2019', 'journal-title': 'JAMA Oncol'}, { 'issue': '8', 'key': 'zoi200372r26', 'doi-asserted-by': 'publisher', 'first-page': '1369', 'DOI': '10.4161/auto.29118', 'article-title': 'Phase I trial of hydroxychloroquine with dose-intense temozolomide in ' 'patients with advanced solid tumors and melanoma.', 'volume': '10', 'author': 'Rangwala', 'year': '2014', 'journal-title': 'Autophagy'}, { 'issue': '3', 'key': 'zoi200372r27', 'doi-asserted-by': 'publisher', 'first-page': '502', 'DOI': '10.1097/IAE.0000000000002027', 'article-title': 'Frequent subclinical macular changes in combined BRAF/MEK inhibition ' 'with high-dose hydroxychloroquine as treatment for advanced metastatic ' 'BRAF mutant melanoma: preliminary results from a phase i/ii clinical ' 'treatment trial.', 'volume': '39', 'author': 'Nti', 'year': '2019', 'journal-title': 'Retina'}, { 'issue': '1', 'key': 'zoi200372r32', 'doi-asserted-by': 'publisher', 'first-page': '264', 'DOI': '10.1016/j.bbrc.2004.08.085', 'article-title': 'In vitro inhibition of severe acute respiratory syndrome coronavirus by ' 'chloroquine.', 'volume': '323', 'author': 'Keyaerts', 'year': '2004', 'journal-title': 'Biochem Biophys Res Commun'}, { 'key': 'zoi200372r15', 'unstructured': 'Science Direct. Chloroquine retinopathy. Accessed March 20, 2020. ' 'https://www.sciencedirect.com/topics/medicine-and-dentistry/chloroquine-retinopathy'}, { 'key': 'zoi200372r28', 'unstructured': 'US Centers for Disease Control and Prevention. CDC 2019-novel ' 'coronavirus (2019-nCoV): real-time RT-PCR diagnostic panel. Updated ' 'March 15, 2020. Accessed April 21, 2020. ' 'https://www.fda.gov/media/134922/download'}, { 'key': 'zoi200372r29', 'unstructured': 'ClinicalTrials.gov. Outcomes Related to COVID-19 Treated With ' 'Hydroxychloroquine Among In-patients With Symptomatic Disease (ORCHID). ' 'Accessed April 21, 2020. ' 'https://clinicaltrials.gov/ct2/show/NCT04332991?term=NCT04332991&draw=2&rank=1'}, { 'key': 'zoi200372r30', 'unstructured': 'ClinicalTrials.gov. Chloroquine Diphosphate in the Prevention of SARS in ' 'Covid-19 Infection (CloroCOVID19II). Accessed April 21, 2020. ' 'https://clinicaltrials.gov/ct2/show/NCT04342650?term=NCT04342650&draw=2&rank=1'}, { 'key': 'zoi200372r31', 'doi-asserted-by': 'crossref', 'unstructured': 'Chorin? E, Dai? M, Shulman? E, . The QT interval in patients with ' 'SARS-CoV-2 infection treated with hydroxychloroquine/azithromycin. ' 'Published April 3, 2020. Accessed April 20, 2020. ' 'https://www.medrxiv.org/content/10.1101/2020.04.02.20047050v1', 'DOI': '10.1101/2020.04.02.20047050'}], 'container-title': 'JAMA Network Open', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://jamanetwork.com/journals/jamanetworkopen/articlepdf/2765499/borba_2020_oi_200372.pdf', 'content-type': 'unspecified', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2020, 4, 27]], 'date-time': '2020-04-27T20:02:40Z', 'timestamp': 1588017760000}, 'score': 1, 'resource': {'primary': {'URL': 'https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2765499'}}, 'subtitle': ['A Randomized Clinical Trial'], 'short-title': [], 'issued': {'date-parts': [[2020, 4, 24]]}, 'references-count': 32, 'journal-issue': {'issue': '4', 'published-print': {'date-parts': [[2020, 4, 1]]}}, 'URL': 'http://dx.doi.org/10.1001/jamanetworkopen.2020.8857', 'relation': { 'has-preprint': [ { 'id-type': 'doi', 'id': '10.1101/2020.04.07.20056424', 'asserted-by': 'object'}]}, 'ISSN': ['2574-3805'], 'subject': [], 'container-title-short': 'JAMA Netw Open', 'published': {'date-parts': [[2020, 4, 24]]}}
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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