A Study to Assess the Efficacy of HH-120 Nasal Spray for Prevention of SARS-CoV-2 Infection in Adult Close Contacts of Individuals Infected With SARS-CoV-2

Capital Medical University

Status: Completed

Conditions: SARS-CoV-2 Infection

Treatments: Drug: HH-120 nasal spray 1; Drug: Placebo Comparator 2; Drug: Placebo Comparator 1; Drug: HH-120 nasal spray 2

Study type: Interventional

Funder types: Other

Identifiers

NCT05765279

HH120-NS02

Details and patient eligibility

About

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

Enrollment: 281 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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281 participants in 4 patient groups, including a placebo group

Treatment Group 1

Experimental group

Treatment:

Drug: HH-120 nasal spray 1

Treatment Group 2

Experimental group

Treatment:

Drug: HH-120 nasal spray 2

Control Group 3

Placebo Comparator group

Treatment:

Drug: Placebo Comparator 1

Control Group 4

Placebo Comparator group

Treatment:

Drug: Placebo Comparator 2