- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04673279
Long-term COVID-19 Immune Response in a Vulnerable Neighbourhood in Argentina
Long-term Persistence of Immunoglobulin G Antibodies Against Severe Acute Respiratory Syndrome Coronavirus 2 in a Vulnerable Neighbourhood in Buenos Aires, Argentina
연구 개요
상세 설명
Background Between June 10t h and July 1st, a cross-sectional design study was carried out in an Argentina slum over people, selected from a probabilistic sample of households showed a prevalence based on IgG-class antibodies against SARS-CoV-2 of 53.4%. In regarding to the persistence of these antibodies, the early data brought hope that acquired immunity was possible. But some subsequent studies have suggested that immune protection might be short-lived. The new findings show that people who survive a COVID-19 infection continue to produce protective antibodies against key parts of the virus for at least three to four months after developing their first symptoms. In contrast, some other antibody types decline more quickly.
It remains unanswered whether natural infection produces a sustained immunity that is capable of establishing herd immunity. The other health problem that Latin America faces is dengue, whose transmission, like SARS-CoV-2, is greater in areas with high population density such as vulnerable neighborhoods. In this context, the occurrence of the two diseases implies a risk, particularly in regions with several dengue serotypes where secondary and tertiary infections have been demonstrated and dengue epidemiological surveillance has been affected by the saturation of health system.
Objectives The aim of this study is to evaluate the presence of IgG antibodies for COVID-19 after 5 months in inhabitants of this slum who consented the Seroprevalence Study for COVID-19, and to evaluate those factors associated with the persistence of positive antibodies. As a secondary objective, the presence of positive IgG for dengue will be evaluated.
Methods Cross sectional study. Population of the study were inhabitants of the slum: men and women form 14 years of age or older were included. People will be invited to participated and detection of antibodies will be performed with ta serological tests, an enzyme linked immunosorbent assay (ELISA) developed and validated in Argentina which detects antibodies against two viral antigens, trimeric spike and the receptor binding domain (RBD) of the spike protein. Blood sample will be collected in a capillary tube from a finger prick taken at the doorstep of each person. Samples will be processed and analyzed at the "Hospital de Niños Doctor Ricardo Gutierrez" Virology laboratory.
Blood sample collection and epidemiological data were collected, and entered in a secure database.
Sample Size The first seroprevalence study included 426 inhabitants of 14 years or more. Considering a persistence of antibodies of 30% with a precision of 5% for a confidence interval of 95% 184 inhabitants should be included. This sample will be selected by a proportionate stratified random sampling, considering the ten sectors in which the slum is divided.
Statistical analysis Descriptive statistics of the data will be carried out according to the variables obtained. Continuous variables will be expressed as mean and standard deviation, and categorical variables as proportions. A multiple logistic regression model will be performed to evaluate the factors associated with the persistence of positive antibodies for SARS-CoV-2.
Dengue seroprevalence is determined globally and by geographic sector. R software version 4.0.2 will be used.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Ciudad De Buenos Aires
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Buenos Aires, Ciudad De Buenos Aires, 아르헨티나, C1425EFD
- Hospital de Niños Ricardo Gutiérrez
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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:
- Men and women form 14 years of age or older who were included in the seroprevalence study and who have positive antibodies against severe acute respiratory syndrome coronavirus 2
Exclusion Criteria:
- deny consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 단면
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
to estimate the proportion of people with positive IgG antibodies for COVID-19 who have positive IgG antibodies after 5 month of the first measurement
기간: up to 20 weeks
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to estimate the proportion of people with positive IgG antibodies for COVID-19 who have positive IgG antibodies after 5 month of the first measurement
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up to 20 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
to estimate the proportion of people with positive IgG antibodies for dengue
기간: up to 20 weeks
|
to estimate the proportion of people with positive IgG antibodies for dengue
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up to 20 weeks
|
공동 작업자 및 조사자
수사관
- 연구 의자: Vanina Pagotto, MD MG, Hospital Italiano de Buenos Aires
- 수석 연구원: Alicia Mistchenko, Phd, Hospital de Niños Ricardo Gutiérrez
- 연구 의자: Silvana Figar, MD MG, Hospital Italiano de Buenos Aires
- 연구 의자: Andrea Gamarnick, Phd, National Council of Scientific and Technical Research, Argentina
- 연구 의자: Ana Maria Gomez Saldaño, MD MG, Salud Comunitaria Ministerio de Salud del Gobierno de la Ciudad de Buenos Aires
- 연구 의자: Lorena Luna, Salud Comunitaria Ministerio de Salud del Gobierno de la Ciudad de Buenos Aires
- 연구 의자: Julieta Salto, Salud Comunitaria Ministerio de Salud del Gobierno de la Ciudad de Buenos Aires
- 연구 의자: Magdalena Wagner Manslau, Salud Comunitaria Ministerio de Salud del Gobierno de la Ciudad de Buenos Aires
- 연구 책임자: Fernan Quiroz, MD MG, Ministerio de Salud del Gobierno de la Ciudad de Buenos Aires
간행물 및 유용한 링크
일반 간행물
- Jordan RE, Adab P, Cheng KK. Covid-19: risk factors for severe disease and death. BMJ. 2020 Mar 26;368:m1198. doi: 10.1136/bmj.m1198. No abstract available.
- Long QX, Tang XJ, Shi QL, Li Q, Deng HJ, Yuan J, Hu JL, Xu W, Zhang Y, Lv FJ, Su K, Zhang F, Gong J, Wu B, Liu XM, Li JJ, Qiu JF, Chen J, Huang AL. Clinical and immunological assessment of asymptomatic SARS-CoV-2 infections. Nat Med. 2020 Aug;26(8):1200-1204. doi: 10.1038/s41591-020-0965-6. Epub 2020 Jun 18.
- Kellam P, Barclay W. The dynamics of humoral immune responses following SARS-CoV-2 infection and the potential for reinfection. J Gen Virol. 2020 Aug;101(8):791-797. doi: 10.1099/jgv.0.001439. Review.
- Wilder-Smith A, Tissera H, Ooi EE, Coloma J, Scott TW, Gubler DJ. Preventing Dengue Epidemics during the COVID-19 Pandemic. Am J Trop Med Hyg. 2020 Aug;103(2):570-571. doi: 10.4269/ajtmh.20-0480. Epub 2020 Jun 15.
- Cardoso MR, Cousens SN, de Góes Siqueira LF, Alves FM, D'Angelo LA. Crowding: risk factor or protective factor for lower respiratory disease in young children? BMC Public Health. 2004 Jun 3;4:19.
유용한 링크
- 2019 Novel Coronavirus (COVID-19) Pneumonia with Hemoptysis as the Initial Symptom: CT and Clinical Features
- SARS-CoV-2 infection induces sustained humoral immune responses in convalescent patients following symptomatic COVID-19
- Community-level SARS-CoV-2 Seroprevalence Survey in urban slum dwellers of Buenos Aires City, Argentina: a participatory research.
- Reductions in commuting mobility correlate with geographic differences in SARS-CoV-2 prevalence in New York City
- The COVID-19 pandemic should not jeopardize dengue control
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
- 3545
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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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. .
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