Overview
Efficacy and Safety of SA58 Nasal Spray in Close Contact With COVID-19 People
Status:
Recruiting
Recruiting
Trial end date:
2023-03-30
2023-03-30
Target enrollment:
0
0
Participant gender:
All
All
Summary
This is a randomized, single-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of SA58 nasal spray in close contact with COVID-19 people.Phase:
N/AAccepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Sinovac Life Sciences Co., Ltd.Collaborator:
Beijing Ditan Hospital
Criteria
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:
- 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.