Study of Biomarkers in the Long-term Impact of Coronavirus Infection in the Cardiorespiratory System (PostCOVID19)
Study of Biomarkers in the Long-term Impact of Coronavirus Infection in the Cardiorespiratory System: Effect of Hydroxychloroquine / Azithromycin Combined Therapy
연구 개요
상태
상세 설명
The aim of this study is to investigate the predictive role of cardiac biomarkers and significant pulmonary complications for late infection complications COVID-19 coronavirus on the heart and lung in patients treated with hydroxychloroquine / combination therapy azithromycin.
COVID-19 positive test patients will be divided into two groups according to therapeutic conduct. So, with a case-control distribution respecting age and sex, the two patient groups will be defined as "arm" with therapy (study population) and "Arm" without therapy (population control). This study is prospective and consists of three times:
1) T0- Moment of inclusion of the patient in the study, which coincides with the collection of clinical data and laboratory tests.
(2) T3- In the 3rd month after inclusion in the study, the patient will make a medical visit where data new laboratory tests will be acquired.
(3) T12- In the 12th month after inclusion in the study, the patient will make another medical visit where data clinical data will be obtained. Laboratory tests, which were altered during visit T3 will be repeated.
COVID-19 coronavirus patients undergoing therapy combined hydroxychloroquine / azithromycin will be compared to patients not undergoing this therapy. The comparison will be performed by analyzing the relationships between (1) troponin levels ultrasensitive cardiac data collected at the beginning of the infection and data of cardiac magnetic resonances in the 3rd and 12th month of collection troponins and (2) acute tomographic findings and the results the ergospirometers tests performed in those same periods.
In our understanding of COVID-19, its diagnosis, prevention and treatment are evolving quickly. As the disease spreads and new evidence emerges, it would be prudent to identify risk factors for the development of late cardiorespiratory complications in patients survivors of serious COVID-19 infections.
This prospective study of patients with COVID-19, involving a systematic record of clinical-laboratory variables and chronic cardiorespiratory complications, will be beneficial for the development of a risk model for these complications and to identify and / or predict the response to various treatment modalities.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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SP
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São Paulo, SP, 브라질
- Instituto do Coração - Hospital das Clínicas - Faculdade de Medicina da Universidade de São Paulo
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- positive test for covid19
- high ultrasensitive troponin
- pulmonary damage > 25%
- no cardiac or lung known disease
- Consent inform signed
Exclusion Criteria:
- intensive care and mechanical ventilation needs
- chronic inflammatory disease
- active neoplasm
- use of immunosuppressant
- renal failure
- pregnant woman
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Arm treatment (HCQ + Azithro)
Participants that used HCQ + Azithro in their treatment for COVID19
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Organize care follow-up for patients who have had COVID-19 coronavirus infection for scientific purposes.
Thus, it is expected to obtain relevant data on cardiac sequelae and pulmonary.
These data are important for understanding the long-term prognosis of patients surviving this infection.
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Arm control (without HCQ + Azithro)
Participants that did not used HCQ + Azithro in their treatment for COVID19
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Organize care follow-up for patients who have had COVID-19 coronavirus infection for scientific purposes.
Thus, it is expected to obtain relevant data on cardiac sequelae and pulmonary.
These data are important for understanding the long-term prognosis of patients surviving this infection.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Fibrosis
기간: 12 months
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presence of fibrosis on cardiac resonance and / or decreased functional capacity on ergospirometry
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12 months
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Ergospirometers
기간: 12 monthes
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Decreased functional capacity on ergospirometers
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12 monthes
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- UAP107
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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