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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 |
|
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"}] |