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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)
Chloroquine diphosphate
Therapy of hospitalized patients
SARS-CoV-2
CloroCOVID-19 Study
All relevant ethical guidelines have been followed; any necessary IRB and/or ethics committee approvals have been obtained and details of the IRB/oversight body are included in the manuscript. Yes. All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes. I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes. I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.
CloroCovid-19 Team (in alphabetical order): Adria Lemos Vasconcelos, Adriana Ferreira Praia Marins, Ágatha Kelly Araújo Costa, Alex Bezerra Silva Maciel, Alexandre Oliveira Trindade, Andiana Souza Dias, André Lima Guerra Corado, Anna Gabriela Rezende Santos, Antônio Guilherme Fonseca Pacheco, Antonny Michael Silva Sousa, Bleno Leonam Gonçalves Costa, Carlos Eduardo Padron Morais, Caroline Santos Soares, Debora Camila Gomes Duarte, Christiane Maria Prado Jeronimo, Ejandre Garcia Negreiros Silva, Elisângela Fátima Ponte Frota, Emanuel Medeiros Marinho Almeida, Emanuelle Lira Silva, Erick Frota Gomes Figueiredo, Fábio Manabu Martins Shimizu, Fabíola Ramalho Ferreira Souza, Fernando Hugo Jesus Fonseca, Flor Ernestina Martinez-Espinosa, Gabrielle Silva Pereira, Hilda Ferreira Melo, Ingrid Nascimento Oliveira, James Dean Oliveira Santos Jr, João Ricardo Silva Neto, Josué Nélio Brutus, Kelry Mazurega Oliveira Dinelly, Laleyska Deucylane Costa Rodrigues, Larissa Esthefani Barros Cirino, Lorenna Pereira Souza, Lucas Barbosa Oliveira, Luiz Carlos Lima Ferreira, Luiz Henrique Gonçalves Maciel, Maria Eduarda Leão Farias, Monique Freire, Nagila Morais Rocha, Natália Guedes Melo Silva, Raíssa Soares Freire, Rebeca Linhares Abreu-Netto, Rodrigo Saboia Lima, Rosângela Francisca Tanantas Melo, Rossicleia Lins Monte, Sheila Vitor-Silva, Thaliê Cavalcante Santos, Valdinete Alves Nascimento, Vitória Silva Printes, Wanessa Pessoa Sousa Barbosa.
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Abstract
Background There is no specific antiviral therapy recommended for the disease caused by SARS-CoV-2 (COVID-19). Recent publications have drawn attention to the possible benefit of chloroquine (CQ). Our study aimed to comprehensively evaluate the safety and efficacy of two different CQ dosages in patients with established severe COVID-19. Methods We performed a parallel, double-blinded, randomized, phase IIb clinical trial, aiming to assess safety and efficacy of two different CQ dosages as adjunctive therapy of hospitalized patients with SARS in Manaus, Brazilian Amazon. Eligible participants were allocated to receive orally or via nasogastric tube high dose CQ (600mg CQ twice daily for 10 days or total dose 12g); or low dose CQ (450mg for 5 days, twice daily only on the first day, or total dose 2.7g). In addition, all patients received ceftriaxone and azithromycin. This study was registered with ClinicalTrials.gov, number NCT04323527. Findings Out of a pre-defined 440 patients sample size, 81 patients were enrolled. The high dose CQ arm presented more QTc>500ms (25%), and a trend toward higher lethality (17%) than the lower dosage. Fatality rate was 13.5% (95%CI=6.9-23.0%), overlapping with the CI of historical data from similar patients not using CQ (95%CI=14.5-19.2%). In 14 patients with paired samples, respiratory secretion at day 4 was negative in only one patient. Interpretation Preliminary findings suggest that the higher CQ dosage (10-day regimen) should not be recommended for COVID-19 treatment because of its potential safety hazards. Such results forced us to prematurely halt patient recruitment to this arm. Given the enormous global push for the use of CQ for COVID-19, results such as the ones found in this trial can provide robust evidence for updated COVID-19 patient management recommendations.
Keywords
COVID-19Chloroquine diphosphate
Therapy of hospitalized patients
SARS-CoV-2
CloroCOVID-19 Study
Citation
BORBA, Mayla Gabriela Silva et al. 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). MedRxiv, p. 1-30, 2020.DOI
10.1101/2020.04.07.20056424Notes
This article is a preprint and has not been certified by peer review [what does this mean?]. It reports new medical research that has yet to be evaluated and so should not be used to guide clinical practice.All relevant ethical guidelines have been followed; any necessary IRB and/or ethics committee approvals have been obtained and details of the IRB/oversight body are included in the manuscript. Yes. All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes. I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes. I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.
CloroCovid-19 Team (in alphabetical order): Adria Lemos Vasconcelos, Adriana Ferreira Praia Marins, Ágatha Kelly Araújo Costa, Alex Bezerra Silva Maciel, Alexandre Oliveira Trindade, Andiana Souza Dias, André Lima Guerra Corado, Anna Gabriela Rezende Santos, Antônio Guilherme Fonseca Pacheco, Antonny Michael Silva Sousa, Bleno Leonam Gonçalves Costa, Carlos Eduardo Padron Morais, Caroline Santos Soares, Debora Camila Gomes Duarte, Christiane Maria Prado Jeronimo, Ejandre Garcia Negreiros Silva, Elisângela Fátima Ponte Frota, Emanuel Medeiros Marinho Almeida, Emanuelle Lira Silva, Erick Frota Gomes Figueiredo, Fábio Manabu Martins Shimizu, Fabíola Ramalho Ferreira Souza, Fernando Hugo Jesus Fonseca, Flor Ernestina Martinez-Espinosa, Gabrielle Silva Pereira, Hilda Ferreira Melo, Ingrid Nascimento Oliveira, James Dean Oliveira Santos Jr, João Ricardo Silva Neto, Josué Nélio Brutus, Kelry Mazurega Oliveira Dinelly, Laleyska Deucylane Costa Rodrigues, Larissa Esthefani Barros Cirino, Lorenna Pereira Souza, Lucas Barbosa Oliveira, Luiz Carlos Lima Ferreira, Luiz Henrique Gonçalves Maciel, Maria Eduarda Leão Farias, Monique Freire, Nagila Morais Rocha, Natália Guedes Melo Silva, Raíssa Soares Freire, Rebeca Linhares Abreu-Netto, Rodrigo Saboia Lima, Rosângela Francisca Tanantas Melo, Rossicleia Lins Monte, Sheila Vitor-Silva, Thaliê Cavalcante Santos, Valdinete Alves Nascimento, Vitória Silva Printes, Wanessa Pessoa Sousa Barbosa.
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