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

Not Applicable

Completed

• Conditions: SARS-CoV-2 Infection
• Interventions: Drug: HH-120 nasal spray 1; Drug: HH-120 nasal spray 2; Drug: Placebo Comparator 1; Drug: Placebo Comparator 2

• Registration Number: NCT05765279
• Lead Sponsor: Beijing Ditan Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-20
• Primary Completion: 2022-12-06
• Study Completion: 2022-12-06
• Status Verified: 2023-03
• Study First Submitted: 2023-03-01
• Study First Submitted QC: 2023-03-01
• Last Update Submitted: 2023-03-01
• Study First Posted: 2023-03-13
• Last Update Posted: 2023-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group 1	HH-120 nasal spray 1	-
Treatment Group 2	HH-120 nasal spray 2	-
Control Group 3	Placebo Comparator 1	-
Control Group 4	Placebo Comparator 2	-

Primary Outcome Measures

Name	Time	Method
Proportion of subjects who have a RT-qPCR confirmed SARS-CoV-2 infection.	Day 1 to Day 10

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects who have a symptomatic RT-qPCR confirmed SARS-CoV-2 infection.	Day 1 to Day 10
Proportion of subjects who have an asymptomatic RT-qPCR confirmed SARS-CoV-2 infection.	Day 1 to Day 10

Trial Locations

Locations (1)

Beijing Ditan Hospital,Capital Medical University; 🇨🇳 Beijing, Beijing, China