Lung Function, Exercise Capacity, and Serology Responses in Patients With COVID-19

Обзор

(a) Objectives 1. To assess the full lung function, exercise capacity, quality of life in patients with COVID-19 over 2 years. 2. To assess the longevity of the serology response to SARS-CoV2. 3. To investigate the association of the neutralization titer in plasma from different vaccinated cohorts to its protection of infection using in vivo model 4. To investigate the SARS-CoV-2 specific cellular and humoral immunities as well as their determinant factors from community subjects who have received different types of COVID-19 vaccines. 5. To assess the third booster dose for subjects who have poor antibody response despite having received two doses of CoronaVac (Sinovac)

Подробное описание

The health conditions of adults (N=300) who recovered from varying severity of COVID-19 will be assessed and their blood are collected at 6, 12, 24 and 36 months after discharge. The assessment package includes: lung function tests, 6-min walk distance, chest radiographs/CT, and SF36 General Health questionnaire. Blood samples from community cohorts will be collected from before and up to 36 months after receiving one of the three COVID-19 vaccines (N=200 per vaccine type). The kinetics of SARS-CoV-2 specific humoral and cellular immunities from both convalescent and vaccinated cohorts are determined by neutralization assay and by measuring specific T cell responses upon stimulation of SARS-CoV-2 specific peptide library respectively. The antiviral level of the human plasma with various neutralization titer collected from different vaccinated cohorts will be tested in mouse model and ADCC assay.

Вмешательства

• Биопрепарат third dose vaccination with CoronaVac vaccine
  Healthy individuals with low antibody levels after 2 doses of CoronaVac vaccine to receive one additional dose of CoronaVac vaccine
• Биопрепарат third dose vaccination with BionTech vaccine
  Healthy individuals with low antibody levels after 2 doses of CoronaVac vaccine to receive one additional dose of BionTech vaccine
• Биопрепарат Vaccination with Coronavac vaccine
  Healthy individuals to receive Coronavac vaccine 2 doses, 21 days apart
• Биопрепарат Vaccination with BionTech Vaccine
  Healthy individuals to receive BionTech vaccine 2 doses, 21 days apart

Первичные конечные точки

• spirometry [Срок оценки: 3 years]
• Lung volume [Срок оценки: 3 years]
• 6 minute walk distance [Срок оценки: 3 years]

Вторичные конечные точки (2)

• quality of life by SF36 questionnaire [Срок оценки: 3 years]
• serology and T cell response [Срок оценки: 3 years]

Критерии участия

Inclusion Criteria: Patients who have been discharged from hospital following treatment for COVID-19 -

Exclusion Criteria: Unwilling to be follow up

\-

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Гонконг · 1 центр

• Prince of Wales Hospital — Гонконг

Публикации

• Chan KKP, Ng SSS, Lui GCY, Leung HS, Wong KT, Chu WCW, Chan TO, Yiu KYS, Tso EYK, To KW, Ngai JCL, Yip TWH, Lo RLP, Ng JKC, Ko FWS, Hui DSC. Comparison of the 12-month impact of COVID-19 and SARS on physiological capacity and health-related quality of life. BMC Pulm Med. 2023 Nov 14;23(1):441. doi: 10.1186/s12890-023-02750-8. PMID 37964259

Идентификаторы

NCT: NCT04611243 · 2020.229

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗