Clinical Impact of COVID-19 by P.1 SARS-CoV-2 Lineage
Clinical Impact of Coronavirus Disease 19 (COVID-19) Caused by P.1 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Lineage
Since the first report of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant of concern (VOC) P.1 in Manaus, Brazil, a rapid spread of this lineage across the country has been observed. Recent studies indicate that this variant is associated with higher transmissibility; it is not known whether it is associated with clinical severity and higher mortality rates.
This is a retrospective cohort study carried out at Hospital de Clínicas de Porto Alegre. Adult patients aged 18 years or more and 65 years or less who were admitted to the hospital due to symptomatic COVID-19 from June 2020 to May 2021 and had a reverse transcriptase-polymerase chain reaction (RT-PCR) cycle threshold value for either SARS-CoV-2 N1 or N2 target ≤ 25 were eligible to the study. Samples from 86 patients (43 from June 2020 to November 2020 and 43 from February 2021 to May 2021) were sequenced for further evaluation. These dates were defined since the emergence of P.1 lineage in late January.
Clinical data regarding ventilatory support, date of onset of symptoms, laboratory findings and mortality were collected from each patient. This retrospective cohort aims to assess whether the number of days needed for supplementary oxygen either by noninvasive ventilation or high-flow nasal cannula from onset of symptoms differs among patients infected with the P.1 SARS-CoV-2 variant and those infected with other variants.
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
RS
-
Porto Alegre, RS, 브라질, 90035-903
- Hospital de Clinicas de Porto Alegre
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Patients aged 18 to 65 years
- Hospital admission due to symptomatic COVID-19
- RT-PCR was collected from June to November 2020 or from February to May 2021
Exclusion Criteria:
- Patients admitted for reasons other than COVID-19
- Asymptomatic patients with positive routine screening with RT-PCR
- Patients transferred from other institutions
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
P.1
Patients infected with the P.1 SARS-CoV-2 variant
|
Collection of clinical and laboratory data
|
|
Other variants
Patients infected with SARS-CoV-2 variants other than P.1
|
Collection of clinical and laboratory data
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Time to Advanced Respiratory Support
기간: 28 days from onset of symptoms
|
Number of days needed for supplementary oxygen either by noninvasive ventilation or high-flow nasal cannula from onset of symptoms.
|
28 days from onset of symptoms
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Proportion of patients in each category in the ordinal scale during hospitalization
기간: 28 days from hospital admission
|
Proportion of patients in each category in the ordinal scale during hospitalization.
Ordinal scale levels: 1, patient not hospitalized; 2, hospitalized and not receiving supplemental oxygen; 3, hospitalized and receiving supplemental oxygen; 4, hospitalized and receiving oxygen supplementation administered by a high-flow nasal cannula or noninvasive ventilation; 5, hospitalized and receiving mechanical ventilation or extracorporeal membrane oxygenation; and 6, death.
|
28 days from hospital admission
|
|
Arterial oxygen partial pressure (PaO2)/ Fractional inspired oxygen (FiO2) evolution during hospitalization
기간: 28 day from hospital admission
|
Proportion of patients in each category according to PaO2/FiO2 value: 400-301, 300-201, 200-101, <=100.
|
28 day from hospital admission
|
|
28-day Mortality from onset of symptoms
기간: 28 days from onset of symptoms
|
Death for any cause from onset of symptoms
|
28 days from onset of symptoms
|
|
Time to death from onset of symptoms
기간: 28 days from onset of symptoms
|
Number of days from the onset of symptoms to death
|
28 days from onset of symptoms
|
|
28-day Mortality from hospital admission
기간: 28 days from hospital admission
|
Death for any cause from hospital admission
|
28 days from hospital admission
|
|
Time to death from hospital admission
기간: 28 days from hospital admission
|
Number of days from the hospital admission to death
|
28 days from hospital admission
|
|
Days alive and free of supplemental oxygen support.
기간: 28 day from hospital admission
|
Number of days alive and free of supplemental oxygen support
|
28 day from hospital admission
|
|
Time to invasive ventilatory support
기간: 28 days from onset of symptoms
|
Number of days from the onset of symptoms to mechanical ventilation or Extracorporeal membrane oxygenation (ECMO)
|
28 days from onset of symptoms
|
|
Need of critical care
기간: 28 days from hospital admission
|
Proportion of patients admitted to Intensive Care Unit
|
28 days from hospital admission
|
|
In-hospital mortality
기간: 90 days from hospital admission
|
Death for any cause during hospitalization
|
90 days from hospital admission
|
|
Number of thromboembolic event
기간: 28 day from hospital admission
|
Number of patients with documented deep venous thrombosis or pulmonary embolism
|
28 day from hospital admission
|
|
Number of patients requiring renal replacement therapy (RRT)
기간: 28 day from hospital admission
|
Number of patients requiring any form of RRT during hospitalization
|
28 day from hospital admission
|
|
Number of patients requiring prone positioning
기간: 28 day from hospital admission
|
Number of patients requiring prone positioning during hospitalization
|
28 day from hospital admission
|
공동 작업자 및 조사자
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
- 2020-0163
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
연구 데이터/문서
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. .