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Trial - NCT05667714


Column Value
Trial registration number NCT05667714
Full text link
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov

First author
Last imported at : Jan. 13, 2023, noon
Source : ClinicalTrials.gov

Not reported

Contact
Last imported at : Jan. 13, 2023, noon
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov

2022-12-29

Recruitment status
Last imported at : Jan. 13, 2023, noon
Source : ClinicalTrials.gov

Not recruiting

Study design
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov

Blind label

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

single-center

Study aim
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov

inclusion criteria: subjects aged 18 years and above on the day of enrollment; had recent contact with an infected person, and the time of pcr sampling from a positive infected person, or the time of first contact with a positive infected person should not exceed 72 hours; the subjects can understand and voluntarily sign the informed consent form;

Exclusion criteria
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov

previous history of severe allergy or sensitivity to inhalation allergens; women are breastfeeding, pregnant, or planning to become pregnant during the study period; participated in clinical trials of sars-cov-2 neutralizing antibody injections within 180 days prior to screening or clinical trials of other drugs within 4 weeks prior to screening; subjects unable to cooperate with nasal spray inhalation; body temperature at baseline (day 0)>37.0℃; had a severe neurological disorder (epilepsy, convulsions or convulsions) or psychosis, and have a family history of psychosis; the researchers determined that the subjects had a serious chronic medical condition that could interfere with the conduct or completion of the study; according to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Number of arms
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov

4

Funding
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov

Sinovac Life Sciences Co., Ltd.

Inclusion age min
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov

100

Countries
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov

China

Type of patients
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov

Close contacts to covid patients

Severity scale
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov

2900

primary outcome
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov

Incidence of symptomatic COVID-19 cases

Notes
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov

None

Phase
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov

Not reported

Arms
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov

[{"arm_notes": "non-continuous exposure to COVID-19", "treatment_id": 2675, "treatment_name": "Sa58 nasal spray", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "non-continuous exposure to COVID-19", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "continuous exposure to COVID-19", "treatment_id": 2675, "treatment_name": "Sa58 nasal spray", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "continuous exposure to COVID-19", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]