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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Aug 14, 2020
Date Accepted: Sep 8, 2020
Date Submitted to PubMed: Sep 14, 2020

The final, peer-reviewed published version of this preprint can be found here:

Impact of Chronic Use of Antimalarials on SARS-CoV-2 Infection in Patients With Immune-Mediated Rheumatic Diseases: Protocol for a Multicentric Observational Cohort Study

Gomides A, FERREIRA G, KAKEHASI A, LACERDA M, MARQUES C, MOTA L, PAIVA E, PILEGGI G, PROVENZA J, REIS-NETO E, SAMPAIO V, XAVIER R, PINHEIRO M

Impact of Chronic Use of Antimalarials on SARS-CoV-2 Infection in Patients With Immune-Mediated Rheumatic Diseases: Protocol for a Multicentric Observational Cohort Study

JMIR Res Protoc 2020;9(10):e23532

DOI: 10.2196/23532

PMID: 32924956

PMCID: 7575340

Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.

IMPACT OF CHRONIC USE OF ANTIMALARIALS ON SARS-CoV-2 INFECTION IN PATIENTS WITH IMMUNE-MEDIATED RHEUMATIC DISEASES: PROTOCOL DESIGN FOR A MULTICENTRIC OBSERVATIONAL COHORT IN BRAZIL

  • Ana Gomides; 
  • GILDA FERREIRA; 
  • ADRIANA KAKEHASI; 
  • MARCUS LACERDA; 
  • CLÁUDIA MARQUES; 
  • LICIA MOTA; 
  • EDUARDO PAIVA; 
  • GECILMARA PILEGGI; 
  • JOSÉ PROVENZA; 
  • EDGARD REIS-NETO; 
  • VANDERSON SAMPAIO; 
  • RICARDO XAVIER; 
  • MARCELO PINHEIRO

ABSTRACT

Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has brought enormous challenges to the scientific community in recent months and several studies have been developed in an attempt to minimize the impact of the disease worldwide. Although new knowledge has been quickly disseminated, including viral mechanisms, pathophysiology, and clinical findings, there is a lack of information about effective pharmacological management of this disease. In vitro studies showed some benefit of antimalarials (Chloroquine and Hydroxychloroquine) on inhibiting SARS-CoV-2. However, the data from open clinical trials are controversial in COVID-19 patients. This research project was developed to compare a potential protective effect to prevent moderate-severe forms of COVID-19 between patients treated chronically with antimalarials for rheumatic diseases and household individuals not diagnosed with IMRD and not taking antimalarials.This prospective observational cohort study includes patients from public and private health services across Brazil who chronically use antimalarials for the treatment of immune-mediated rheumatic diseases (IMRD), osteoarthritis, or chikungunya-related arthropathy. A total of six sequential phone visits were scheduled during 24-weeks of community viral transmission in five different regions of Brazil. All information regarding social, epidemiological, and demographic data, as well as details about rheumatic diseases, antimalarials, comorbidities, and concomitant medication is being recorded on a specific online form on the REDCap database. The symptoms suggestive of COVID-19, including fever, cough, dyspnea, anosmia, and dysgeusia, are being self-reported and collected by phone interviews. Our main outcomes are hospitalization, need of intensive care unit, and death. Trial registration: The project, which is currently in the data collection phase, was approved by the Brazilian Committee of Ethics in Human Research – CONEP (CAAE 30246120.3.1001.5505) and registered at the Brazilian Registry of Clinical Trials (ReBEC; number RBR- 9KTWX6)


 Citation

Please cite as:

Gomides A, FERREIRA G, KAKEHASI A, LACERDA M, MARQUES C, MOTA L, PAIVA E, PILEGGI G, PROVENZA J, REIS-NETO E, SAMPAIO V, XAVIER R, PINHEIRO M

Impact of Chronic Use of Antimalarials on SARS-CoV-2 Infection in Patients With Immune-Mediated Rheumatic Diseases: Protocol for a Multicentric Observational Cohort Study

JMIR Res Protoc 2020;9(10):e23532

DOI: 10.2196/23532

PMID: 32924956

PMCID: 7575340

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