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Trial - ChiCTR2100050589


Column Value
Trial registration number ChiCTR2100050589
Full text link
Last imported at : Sept. 24, 2021, 6 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

First author
Last imported at : Sept. 24, 2021, 6 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Wei Jia

Contact
Last imported at : Sept. 24, 2021, 6 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

weijia19631225@163.com

Registration date
Last imported at : Sept. 24, 2021, 6 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2021-08-31

Recruitment status
Last imported at : Sept. 24, 2021, 6 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Recruiting

Study design
Last imported at : Sept. 24, 2021, 6 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

nonRCT

Allocation
Last imported at : Sept. 24, 2021, 6 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Non-randomized

Design
Last imported at : Sept. 24, 2021, 6 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Sequential assignment

Masking
Last imported at : Sept. 24, 2021, 6 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not reported

Center
Last imported at : Sept. 24, 2021, 6 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

single-center

Study aim
Last imported at : Sept. 24, 2021, 6 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Prevention

Inclusion criteria
Last imported at : Sept. 24, 2021, 6 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

1. The participants were 18 to 75 years old, male or female, 2. Two doses of inactivated SARS-CoV-2 vaccine were administered recently and the interval between two doses was 3-5 weeks, 3. The neutralization antibody levels were negative or less than 20% average antibody level of COVID-19 recovered patients in 14 days after administering two doses of SARS-CoV-2 vaccine, 4. It is now in 4-24 weeks after administering second dose of SARS-CoV-2 vaccine, 5. Participants can follow the researchers guidance to accomplish the research process.

Exclusion criteria
Last imported at : Sept. 24, 2021, 6 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

1. The history of SARS-CoV-2 infection, 2. The History of vaccination against other types of SARS-CoV-2 vaccine other than inactivated SARS-CoV-2 vaccine, 3. Severe mental and neurological disease, 4. The following common disease (coronary heart disease, hypertension, diabetes, chronic respiratory diseases, tumors, etc.) and poorly controlled, 5. Immune deficiency or immunosuppressive therapy patients, 6. According to the researchers, any other factors that the subjects do not fit to participate in this clinical trials.

Number of arms
Last imported at : Sept. 24, 2021, 6 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

1

Funding
Last imported at : Sept. 24, 2021, 6 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

The Afiliated Hospital of Yunnan University

Inclusion age min
Last imported at : Sept. 24, 2021, 6 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

18

Inclusion age max
Last imported at : Sept. 24, 2021, 6 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

75

Countries
Last imported at : Sept. 24, 2021, 6 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

China

Type of patients
Last imported at : Sept. 24, 2021, 6 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Healthy volunteers

Severity scale
Last imported at : Sept. 24, 2021, 6 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

N/A

Total sample size
Last imported at : Sept. 24, 2021, 6 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

500

primary outcome
Last imported at : Sept. 24, 2021, 6 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Neutralizing antibody level;Antigen-specific memory T cells;

Notes
Last imported at : Sept. 24, 2021, 6 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Phase
Last imported at : Sept. 24, 2021, 6 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Phase 4

Arms
Last imported at : Sept. 24, 2021, 6 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

[{"arm_notes": "third dose;4-24 weeks", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]