SARS CoV 2 InfectionFASTERNCT05244330
Effectiveness of COVID-19 Vaccines Against the SARS-COV-2 Delta (B.1.617.2)
An observational study of SARS CoV 2 Infection, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- SARS CoV 2 Infection
- Type of treatment
- Vaccines
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2021to 15 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with SARS-COV-2 Delta infection in Xi'an, Shaanxi Province, China, from December 2021 to January 2022
Who may be able to join
- 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
Who cannot join
- Pregnant women
- Clinical diagnosis of organ dysfunction or failure before infection
- Long-term use of immunosuppressants or immunodeficiency patients
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Xian JiaotongUniversity
Xi'an, Shaanxi, 710061
About this study
Official title: Effectiveness of COVID-19 Vaccines Against the SARS-COV-2 Delta (B.1.617.2) in China-A Real World Study
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.
Read the 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.
- Conditions
- SARS CoV 2 Infection
- Keywords
- SARS-COV-2 Delta (B.1.617.2 ), vaccine, China, protective effect
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of severe and critical cases
the proportion of severe and critical cases during hospitalization
Measured: during hospitalization, an average of 1 month
Secondary outcomes (1)
the duration of viral shedding
the duration of SARS-COV-2 Delta (B.1.617.2) shedding
Measured: during hospitalization, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start15 Dec 2021
- Primary completion15 Jan 2022
- Study completion15 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS CoV 2 InfectionStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kai Qu, Doctor, Study director, First Affiliated Hospital Xi'an Jiaotong UniversityGuoliang Li, Doctor, Study director, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244330
- Sponsor's protocol ID
- XJTU1AF2022LSK-001
- Acronym
- FASTER
- Status last verified
- Jan 2022
- First submitted
- 13 Jan 2022
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of COVID-19 Vaccines Against the SARS-COV-2 Delta (B.1.617.2) in China-A Real World Study
- ClinicalTrials.gov ID
- NCT05244330
- Acronym / sponsor ID
- FASTER / XJTU1AF2022LSK-001
- Conditions
- SARS CoV 2 Infection
- Keywords
- SARS-COV-2 Delta (B.1.617.2 ), vaccine, China, protective effect
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 15 Jan 2022 (actual)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with SARS-COV-2 Delta infection in Xi'an, Shaanxi Province, China, from December 2021 to January 2022
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnant women
- Clinical diagnosis of organ dysfunction or failure before infection
- Long-term use of immunosuppressants or immunodeficiency patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Other | Full vaccination, Partial vaccination, Unvaccinated |
Primary outcome
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
1 secondary outcome
the duration of viral shedding
Time frame: during hospitalization, an average of 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kai Qu, Doctor study director
First Affiliated Hospital Xi'an Jiaotong University
Guoliang Li, Doctor study director
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS CoV 2 Infection, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the proportion of severe and critical cases (time frame: during hospitalization, an average of 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2022.