Effect of the use of Chloroquine and Hydroxychloroquine as a possible protector for Infection with the New Corona Virus 2019 in patients with Rheumatic Diseases

Not Applicable

Recruiting

• Conditions: Severe Acute Respiratory Syndrome; Rheumatic Diseases; C02.782.600.550.200.750; C05.799

• Registration Number: RBR-9ktwx6
• Lead Sponsor: Socidade Brasileira de Reumatologia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-09
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Age greater than or equal to 18 years; use of antimalarial drugs for at least 30 days before inclusion; diagnosis of immune mediated rheumatic disease defined according to American College of Rheumatology (ACR) or European League against Rheumatism (EULAR) criteria: rheumatoid arthritis (RA), systemic lupus erythematosus (SLE, Sjogren's syndrome (SS), systemic sclerosis, myopathies inflammatory diseases, mixed connective tissue disease (DMTC), systemic sclerosis (ES); diagnosis of osteoarthritis (OA) of hands (subgroup).

Exclusion Criteria

Previous use of antimalarial, but not current in the last 6 months; history of solid organ or bone marrow transplantation; neoplasm of solid organs or lymphatic or myeloproliferative lineage in the last 12 months with or without adjuvant chemotherapy; use of intravenous human immunoglobulin in the last 30 days.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the incidence of SARS-CoV-2 infection, suspected or confirmed, during the follow-up period, comparing the frequency between the patient and his home contacts included in the study, according to the definitions of the Ministry of Health of Brazil.;Determine the frequency of deaths in suspected or confirmed cases of SAR-Cov-2 infection in patients with rheumatic diseases by comparing with their home contacts included in the study;Evaluate the need for hospitalization due to SARS-CoV-2 infection in patients with rheumatic diseases compared to their home contacts included in the study, including the following parameters: total hospitalization time, need for admission to the intensive care unit, need for mechanical ventilation during hospitalization

Secondary Outcome Measures

Name	Time	Method
To evaluate the general clinical differences of COVID-19 in the comparison between rheumatic patients and non-rheumatic controls. The data on the incidence of symptoms related to COVID-19 in patients with rheumatic diseases and their controls will be compared, both in cases considered mild (flu-like symptoms) and among severe cases (respiratory diseases, neurological diseases, gastrointestinal diseases).