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NCT Number: NCT05244330

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

First Affiliated Hospital of Xian JiaotongUniversity

Xi'an, Shaanxi, 710061, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. the proportion of severe and critical cases

    Time frame: during hospitalization, an average of 1 month

    the proportion of severe and critical cases during hospitalization

Secondary outcomes

  1. the duration of viral shedding

    Time frame: during hospitalization, an average of 1 month

    the duration of SARS-COV-2 Delta (B.1.617.2) shedding

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Registry information

Official study title

Effectiveness of COVID-19 Vaccines Against the SARS-COV-2 Delta (B.1.617.2) in China-A Real World Study

Acronym: FASTER

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 17, 2022
Registry last updated
Feb 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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