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

Completed

• Conditions: SARS CoV 2 Infection

• Registration Number: NCT05244330
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

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.

Detailed Description

In this study, through follow-up of SARS-COV-2 Delta infection patients in Xi 'an, Shaanxi Province, China, exploring the effects of vaccination on nucleic acid turning negative, clinical characteristics and prognosis of patients infected with SARS-COV-2 Delta, so as to clarify the protective effects of vaccination on SARS-COV-2 Delta.

Study Timeline

• Study Start: 2021-12-15
• Status Verified: 2022-01
• Study First Submitted: 2022-01-13
• Primary Completion: 2022-01-15
• Study Completion: 2022-01-15
• Study First Submitted QC: 2022-02-16
• Last Update Submitted: 2022-02-16
• Study First Posted: 2022-02-17
• Last Update Posted: 2022-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the proportion of severe and critical cases	during hospitalization, an average of 1 month	the proportion of severe and critical cases during hospitalization

Secondary Outcome Measures

Name	Time	Method
the duration of viral shedding	during hospitalization, an average of 1 month	the duration of SARS-COV-2 Delta (B.1.617.2) shedding

Trial Locations

Locations (1)

First Affiliated Hospital of Xian JiaotongUniversity; 🇨🇳 Xi'an, Shaanxi, China