Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Safety and Effectiveness of SA58 Nasal Spray Against COVID-19 Infection in Medical Personnel：An Open-label, Blank-controlled Study

ID
Name
PRO-SA58-0001
Description
This is an open, blank controlled clinical trial to evaluate the efficacy and safety of SA58 nasal spray in the prevention COVID-19 infection among health care workers at high risk of SARS-CoV-2 infection.
Trial arms
Trial start
2022-10-30
Estimated PCD
2022-12-31
Trial end
2023-03-31
Status
Active (not recruiting)
Treatment
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.
Arms:
Drug group
Size
7000
Primary endpoint
COVID-19 infection rates
Up to 30 days(during case surveillance period)
Eligibility criteria
Inclusion Criteria: * Medical staff working in the designated COVID-19 hospitals and Fangcang shelter hospitals (alternate care sites) of COVID-19 cases in Hohhot; * Subjects were 18 years of age and older and in good health; * Subjects volunteered to use COVID-19 neutralizing antibody nasal spray. Exclusion Criteria: * Previous history of severe allergies or sensitivity to inhaled allergens; * Women were pregnant or breastfeeding; * Subjects were unable to cooperate with nasal spray inhalation; * Other conditions for which medication was not appropriate.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 7000, 'type': 'ESTIMATED'}}
Updated at
2023-01-12

1 organization

1 product

1 indication

Organization
Sinovac Life Sciences
Product
SA58
Indication
COVID-19