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SARS-CoV-2 Infection Among Healthcare Workers

Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Other)
Overall Status
Recruiting
CT.gov ID
NCT05680896
Collaborator
(none)
600
Enrollment
1
Location
22.7
Anticipated Duration (Months)
26.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

At present, COVID-19 vaccine is considered as the safest, economic and effective measure to prevent and control COVID-19. Adaptive immunity, including humoral immunity and cellular immunity, plays a role in anti-viral responses. Cellular immunity includes virus specific B cells and T cells, which can provide long-term memory immunity. For acute viral infection, neutralizing antibody is of great significance in preventing infection, while memory cell immunity can maintain a good broad-spectrum and persistence in controlling mutant strains, which is a key factor in controlling viral replication after infection and reducing severe disease and death. However, there is no systematic study on the specific immune response and infection risk of novel coronavirus, and there is no definite conclusion on which specific protective immune response induced by vaccine can reduce the risk of infection. Therefore, this study aims to establish a prospective real-world cohort, analyze the correlation between multiple baseline immune protection indicators and infection risk, follow up the population with breakthrough infection, and monitor the dynamic specific immune response to COVID-19 in peripheral blood and respiratory mucosa. This study will provide an important scientific basis for us to scientifically assess the risk of individual infection with COVID-19.

Condition or Disease Intervention/Treatment Phase
  • Biological: inactivated COVID-19 vaccines; orally aerosolized Ad5-nCoV

Study Design

Study Type:
Observational
Anticipated Enrollment :
600 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Risk of SARS-CoV-2 Infection and Severity of COVID-19 Among Healthcare Workers With or Without Previous COVID-19 Vaccines
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Mar 21, 2023
Anticipated Study Completion Date :
Dec 22, 2024

Outcome Measures

Primary Outcome Measures

  1. SARS-CoV-2 infection [from Dec 2022 to April 2023]

    SARS-CoV-2 infection confirmed by either by nucleic acid testing or antigen testing

  2. The severity of COVID-19 [from Dec 2022 to April 2023]

    the severity of COVID-19 symptoms including the period from SARS-CoV-2 positive to negative, fever days, etc.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  1. Age ≥18 years

  2. SARS-CoV-2 nucleic acid testing showed negative within 72 hours

Exclusion Criteria:

1.Do not consent to enroll in this study

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Nanjing Jiangsu China 210008

Sponsors and Collaborators

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Investigators

  • Principal Investigator: Chao Wu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chao Wu, Professor, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier:
NCT05680896
Other Study ID Numbers:
  • 20222-746
First Posted:
Jan 11, 2023
Last Update Posted:
Jan 11, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of Jan 11, 2023