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History of Changes for Study: NCT04611243
Lung Function, Exercise Capacity, and Serology Responses in Patients With COVID-19
Latest version (submitted August 17, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 29, 2020 None (earliest Version on record)
2 August 17, 2021 Groups and Interventions, Study Status, Outcome Measures, Study Description and Study Design
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Study NCT04611243
Submitted Date:  October 29, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: 2020.229
Brief Title: Lung Function, Exercise Capacity, and Serology Responses in Patients With COVID-19
Official Title: Lung Function, Exercise Capacity, and Serology Responses in Patients With COVID-19
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2020
Overall Status: Recruiting
Study Start: May 22, 2020
Primary Completion: May 21, 2022 [Anticipated]
Study Completion: May 21, 2022 [Anticipated]
First Submitted: June 29, 2020
First Submitted that
Met QC Criteria:
October 29, 2020
First Posted: November 2, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
October 29, 2020
Last Update Posted: November 2, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Chinese University of Hong Kong
Responsible Party: Principal Investigator
Investigator: Prof David Shu Cheong Hui
Official Title: Professor
Affiliation: Chinese University of Hong Kong
Collaborators: The University of Hong Kong
Health and Medical Research Fund
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary:

(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.
Detailed Description:

(b) Study design Adult patients (about 80) who have been discharged following treatment for COVID-19 will be followed up at the Prince of Wales Hospital at 4 weeks after discharge, 6, 12, 18 and 24 months similar to our previous studies for SARS patients in 2003. The assessment at each timepoint includes: lung volume (total lung capacity [TLC], vital capacity, residual volume, functional residual capacity), spirometry (FVC, FEV1), diffusing capacity of the lung for carbon monoxide (DLCO), 6-min walk distance, chest radiographs, and Medical Outcomes Study 36-Item Short-Form General Health Survey questionnaire. In addition, blood will be taken for ELISA to detect IgG and IgM antibody to the receptor-binding domain of the spike protein of SARS-CoV-2 and evaluate its sensitivity and specificity together with 90% plaque reduction neutralization tests.

T cell assays for SARS-CoV will be carried out on the blood samples collected at 6 and 24 months.

(c) Expected outcome(s) This study will inform if there is any impairment of lung function, exercise capacity and quality of life among patients with confirmed COVID-19. In addition the study will provide data on the titre and longevity of the serology response.

Open or close this module Conditions
Conditions: Lung Function
Exercise Capacity
Quality of Life
Covid19
Keywords:
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention: Samples Without DNA
Biospecimen Description: Blood will be taken for serology testing and T cell response after discharge, 6, 12, 18 and 24 months.
Enrollment: 80 [Anticipated]
Number of Groups/Cohorts 3
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
Kaletra, beta interferon +- ribavirin
Patients received lopinavir/ ritonavir 400mg/100mg (Kaletra) BD po for 7-14 days, Interferon beta-1b 0.25mg (8 MIU) subcutaneous alt day (maximum 7 doses) up to 14 days of symptom onset +- ribavirin 400mg bd for up to 14 days
Drug: Kaletra and beta interferon
kaletra and beta interferon vs remdesivir vs supportive treatment

Other Names:
  • Remdesivir
  • Supportive treatment
Remdesivir
Patients received remdesivir 200mg on first day followed by 100 mg daily for 5 to 10 days
Supportive treatment
Patients only received antipyretic as needed
Open or close this module Outcome Measures
Primary Outcome Measures:
1. spirometry
[ Time Frame: 2 years ]

FEV1 and FVC
2. Lung volume
[ Time Frame: 2 years ]

Litres
3. 6 minute walk distance
[ Time Frame: 2 years ]

meters
Secondary Outcome Measures:
1. quality of life by SF36 questionnaire
[ Time Frame: 2 years ]

scores in all domains
2. serology and T cell response
[ Time Frame: 2 years ]

titers
Open or close this module Eligibility
Study Population: Adult patients (about 80) who have been discharged following treatment for COVID-19 will be followed up at the Prince of Wales Hospital at 4 weeks after discharge, 6, 12, 18 and 24 months.
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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

Exclusion Criteria: Unwilling to be follow up

-

Open or close this module Contacts/Locations
Central Contact Person: Susanna Ng, MBChB
Telephone: 85235053128
Email: drsssng@gmail.com
Central Contact Backup: Karen Yiu, BSc
Telephone: 85235053532
Email: ysyiu@cuhk.edu.hk
Study Officials: David S Hui, MD
Principal Investigator
Chinese University of Hong Kong
Locations: Hong Kong
Prince of Wales Hospital
[Recruiting]
Hong Kong, Hong Kong
Contact:Contact: Susanna So-Shan Ng 3505 2785 drsssng123@yahoo.com.hk
Open or close this module IPDSharing
Plan to Share IPD: Undecided
data pending
Open or close this module References
Citations:
Links:
Available IPD/Information:

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