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Trial - NCT05194033


Column Value
Trial registration number NCT05194033
Full text link
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05194033

First author
Last imported at : July 12, 2022, 1:30 a.m.
Source : ClinicalTrials.gov

Not reported

Contact
Last imported at : July 12, 2022, 1:30 a.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

2022-01-18

Recruitment status
Last imported at : July 12, 2022, 1:30 a.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : Feb. 2, 2022, 1 p.m.
Source : ClinicalTrials.gov

inclusion criteria: 18 ≤age ≤59 years; vaccinated with two doses of sars-cov-2 vaccine (manufactured by sino biopharmaceutical limited or sinovac biotech co., ltd.) (≥6 months from the time of vaccination). not vaccinated third dose vaccination; voluntarily participate in the study with signed informed consent form.

Exclusion criteria
Last imported at : July 12, 2022, 1:30 a.m.
Source : ClinicalTrials.gov

pregnancy or lactation period; infected with human immunodeficiency virus (hiv), hepatitis b virus (hbv) or hepatitis c virus (hcv); plan to vaccinate third dose of sars-cov-2 vaccine within 2 months; history of autoimmune diseases (e.g. rheumatoid arthritis, systemic lupus erythematosus, dry syndrome, etc.); previously infected with sars-cov-2 or close contact of sars-cov-2 infected individual; other sars-cov-2 vaccination history (not manufactured by sino biopharmaceutical limited or sinovac biotech co., ltd.); end-stage cancer or other terminal diseases with life expectancy <6 month; history of severe cardiovascular and cerebrovascular diseases, such as heart failure, uncontrolled coronary heart disease, cardiomyopathy, uncontrolled arrhythmia,or history of myocardial or cerebral infarction within past six months; participating in other clinical trials.

Number of arms
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

Peking University

Inclusion age min
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

59

Countries
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

China

Type of patients
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

Healthy volunteers

Severity scale
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : July 12, 2022, 1:30 a.m.
Source : ClinicalTrials.gov

31

primary outcome
Last imported at : July 12, 2022, 1:30 a.m.
Source : ClinicalTrials.gov

T-cell response level;The serum neutralizing antibody level of SARS-CoV-2.

Notes
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

Not reported

Arms
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "Vaccinated with two doses of SARS-CoV-2 vaccine (manufactured by Sino Biopharmaceutical Limited or SINOVAC BIOTECH CO., LTD.) (\u22656 months from the time of vaccination).", "treatment_id": 1022, "treatment_name": "Probiotics", "treatment_type": "Microbiota intervention", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "Vaccinated with two doses of SARS-CoV-2 vaccine (manufactured by Sino Biopharmaceutical Limited or SINOVAC BIOTECH CO., LTD.) (\u22656 months from the time of vaccination).", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]