Effectiveness of COVID-19 Vaccines Against the SARS-COV-2 Delta (B.1.617.2)

NCT05244330 | Completed

• 1 other identifier: XJTU1AF2022LSK-001
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

Up to now, Corona Virus Disease 2019 (COVID-19) continues to spread rapidly around the world. From the beginning of the epidemic to the present, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has continuously evolved and mutated, producing transmissible and virulent variants. At present, the infection rate of Delta variant strains is still increasing globally. The epidemic strain of novel coronavirus infection in Xi 'an city is δ (B.1.617.2). SARS-CoV-2 Delta has more infectious, higher viral load and shorter incubation period than other SARS-COV-2 delta strains. Several studies have shown that the protective efficacy of vaccines against different SARS-COV-2 virus variants is different, and SARS-COV-2 viral load is closely related to transmission, clinical phenotype and prognosis of infected patients. According to the notice of Xi'an Municipal Health Commission, a total of 2,139 local confirmed cases were reported in Xi 'an on January 10,2022, and the proportion of severe cases was 2.36%, which was significantly lower than the 7% of nation since the second half of 2020. According to the preliminary investigation by the applicant's team, the severe illness rate in Xi'an has decreased significantly, which benefits from the active promotion of domestic vaccination, early intervention, and use of neutralizing antibodies. The purpose of this study is to analyze the effects of vaccination on nucleic acid turning negative, clinical characteristics and prognosis of patients infected with SARS-COV-2 delta, and to clarify the protective effects of vaccination, which is of great significance for the prevention and control of the SARS-COV-2 delta (B.1.617.2) in Xi' an.

Conditions

SARS CoV 2 Infection

Keywords

SARS-COV-2 Delta (B.1.617.2 ); vaccine; China; protective effect

Outcome Measures

Primary Outcomes (1)

• the proportion of severe and critical cases

  the proportion of severe and critical cases during hospitalization

  during hospitalization, an average of 1 month

Secondary Outcomes (1)

• the duration of viral shedding

  during hospitalization, an average of 1 month

Study Arms (3)

Partial vaccination

One dose of vaccine received at least 7 days prior to study enrollment

Full vaccination

Two doses of COVID-19 vaccine received at least 7 days prior to study enrollment

Unvaccinated

No dose of COVID-19 vaccine for at least 7 days prior to study enrollment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with SARS-COV-2 Delta infection in Xi'an, Shaanxi Province, China, from December 2021 to January 2022

You may qualify if:

• Diagnosed with SARS-COV-2 Delta infection
• Clear vaccination information
• Plasma viral load measurements within 24 hours of admission to the hospital
• Performing continuous plasma viral load measurements
• Obtaining informed consent

You may not qualify if:

• Pregnant women
• Clinical diagnosis of organ dysfunction or failure before infection
• Long-term use of immunosuppressants or immunodeficiency patients

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xian JiaotongUniversity

Xi'an, Shaanxi, 710061, China

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Kai Qu, Doctor

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY DIRECTOR

• Guoliang Li, Doctor

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: February 17, 2022
• Study Start: December 15, 2021
• Primary Completion: January 15, 2022
• Study Completion: January 15, 2022
• Last Updated: February 17, 2022

Record last verified: 2022-01

Locations

CN (1)