SARS-CoV-2 Infection Among Healthcare Workers

COVID-19 Clinical Trial

Official title:

The Risk of SARS-CoV-2 Infection and Severity of COVID-19 Among Healthcare Workers With or Without Previous COVID-19 Vaccines

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05680896
• Other study ID #: 20222-746
• Status: Recruiting
• Start date: February 1, 2023
• Est. completion date: December 22, 2024

Study information

• Verified date: January 2023
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Chao Wu, PhD
• Phone: +8613809022921
• Email: dr.wu[@]nju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 22, 2024
• Est. primary completion date: March 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• inactivated COVID-19 vaccines; orally aerosolized Ad5-nCoV
the protection of COVID-19 vaccines on breakthrough infection

Locations

Country	Name	City	State
China	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SARS-CoV-2 infection	SARS-CoV-2 infection confirmed by either by nucleic acid testing or antigen testing	from Dec 2022 to April 2023
Primary	The severity of COVID-19	the severity of COVID-19 symptoms including the period from SARS-CoV-2 positive to negative, fever days, etc.	from Dec 2022 to April 2023