This is a randomized, single-blind, placebo-controlled clinical trial to evaluate theefficacy and safety of SA58 nasal spray in close contact with COVID-19 people.
This study is a randomized, single-blind, placebo-controlled clinical trial in close
contacts to COVID-19. The investigational drug was manufactured by Sinovac Life Sciences
Co. , Ltd.The purpose of this study is to estimate the efficacy and safety of SA58 nasal
spray in close contacts to COVID-19. A total of 2900 subjects were planned to be
enrolled,including 2300 subjects who were non-continuous exposed to COVID-19 in group
A,600 subjects who were continuous exposed to COVID-19 in group B. All subjects started
medication on the day of enrollment. During the medication period, the subjects were
given nasal spray once every 3 hours,about 5-6 times a day.
Drug: SA58 Nasal Spray
SA58 nasal spray , provided by Sinovac Life Sciences Co. , Ltd. mainly consists of
neutralizing antibody of COVID-19, with 5 mg neutralizing antibody of COVID-19 per ml, 20
sprays per bottle.
Drug: Placebo
Placebo was provided by Sinovac Life Sciences Co. , Ltd.
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.
Beijing Ditan Hospital, Capital Medical University
Beijing, China
Ronghua Jin, Principal Investigator
Beijing Ditan Hospital