- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04402905
Observational Study in Diagnosed Patients COVID-19, Supported on an Outpatient Basis. (COVID-PSL) (COVID-PSL)
Observational Study in Diagnosed Patients Covid-19, Supported on an Outpatient Basis.
COVID-19 is an infection linked to a new coronavirus: SARS-CoV-2, which appeared in Wuhan in China at the end of 2019, and which has since spread around the world, responsible for a new major pandemic, which is upsetting the whole world.
If severe respiratory disease is the form that constitutes the extreme gravity of the disease (mortality, with more than 170,000 deaths worldwide to date).
However, there is a great heterogeneity of clinical forms with asymptomatic or symptomatic pauci forms, moderate forms, up to severe forms.
Different symptoms may appear: fever, cough, asthenia, dyspnea, gastrointestinal forms, anosmia and / or ageusia, skin involvement, etc.
Given the novelty of this infection, several questions remain:
- What are all the symptoms that can be contracted by a COVID-19 patient?
- Are there clinical forms not described?
- What is the evolutionary profile, the healing time of this disease in patients treated on an outpatient basis?
- What are the factors associated with a prolonged form of COVID-19 disease, including on an outpatient basis?
연구 개요
상태
정황
상세 설명
Most of the descriptive studies relating to COVID-19 relate to the severe forms of the disease managed in the hospital sector.
Few data have been published on moderate forms, requiring no hospitalization, of strict outpatient management.
These so-called moderate forms, however, constitute the majority of cases of COVID-19 (approximately 80%).
In the Infectious and Tropical Diseases Department of Pitie Salpetriere, COVIDOM pilot site, at the beginning of March, during the intensification of the epidemic in France, a weekly telephone consultation was set up to take care of people tested for COVID + by PCR, or people not tested by PCR, or even tested with negative PCR but symptomatic and followed at home, suffering from moderate form of COVID-19, as well as their contact cases if they wished.
Telemedicine is particularly suitable in this epidemic context, ensuring continuity of care, while limiting face-to-face consultations, thus reducing the risk of cross-contamination.
Given the novelty of this infection, it is important to be able to best characterize these ambulatory forms, as well as their evolution, in order to manage these patients, and to offer primary care physicians a more detailed description of these forms. , which they are and will be called upon to take care of, general medicine being central to dealing with the epidemic.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
-
Paris, 프랑스, 75013
- Yasmine Dudoit
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Enrolment will be done from the active queue of patients included in the COVIDOM / PSL platform.
This study will be a monocentric data collection. The patient is called, on working days, weekly from D0 to D30, and beyond if the symptoms persist on D30.
Data will be collected at D0, D7, D14, D21 and D30. The visit on D30 corresponds to the end of the systematic weekly telephone interviews if the patient has reached complete recovery, defined by the absence of symptoms for 3 days.
If the symptoms persist on D30: monitoring is continued, on D45 and D60, and beyond if necessary.
설명
Inclusion Criteria:
- Age >18 years
- COVID PCR + patient: Patient screened positive by PCR on nasopharyngeal swab
- or COVID-like patient: Patient not screened, but considered COVID + because contact with a COVID PCR + person, and presenting symptoms suggestive of COVID-19 among:
- Influenza-like illness (fever, body aches, arthralgia, etc.)
- Respiratory form: dyspnea, cough, rhinitis
- Gastrointestinal form: diarrhea, nausea, vomiting
- Anosmia and / or ageusia
- or patient COVID PCR-: If patient tested negative by PCR on nasopharyngeal swab, but showing signs suggestive of COVID-19.
Exclusion Criteria:
- Patient objecting to the use of their data for research purposes
- Patient under justice or deprived of liberty.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 회고전
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
COVID-PSL Cohort
기간: 3 months
|
measure of the absence of symptoms to assess the rate of complete clinical recovery on day 30
|
3 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Christine Katlama, MD, Pitie-Salpêtrière Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
- CREPATS 011
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .