An Investigator Initiated Clinical Study To Evaluate the Efficacy and Safety of HH-120 Nasal Spray as Post Exposure Prophylaxis (PEP) Regimen in Adult Close Contacts of Individuals Infected With SARS-CoV-2

HH120-NS02

An Investigator-initiated, Randomized, Single-Blind, Placebo-Controlled Trial to Evaluate the Efficacy of SARS-Cov-2 Post Exposure Prophylaxis and Safety of HH-120 nasal spray

2022-10-20

2022-12-06

2022-12-06

Completed

281

Inclusion Criteria: * Participants aged 18 to 65 years. * Participants who have close contact with a SARS-CoV-2 infected individual (index case) are required to be randomized within 72 hours upon close contact. * Willing and able to provide written informed consent, or with a legal representative who can provide informed consent. Exclusion Criteria: * Have a history of severe allergy or hyper-sensitivity to inhaled allergen. * Pregnant or breastfeeding women. * Have participated, within the last 180 days prior to the screening, in a clinical study involving an investigational intervention of SARS-CoV-2 neutralizing antibody. * Have other conditions not suitable for the study per investigator's discretion.

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 281, 'type': 'ACTUAL'}}

2023-03-13