Overview

Efficacy and Safety of SA58 Nasal Spray in Close Contact With COVID-19 People

Status:
Recruiting
Trial end date:
2023-03-30
Target enrollment:
0
Participant gender:
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/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
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.