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

SARS-CoV-2 Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05765279
• Other study ID #: HH120-NS02
• Status: Completed
• Phase: N/A
• Start date: October 20, 2022
• Est. completion date: December 6, 2022

Study information

• Verified date: March 2023
• Source: Beijing Ditan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 281
• Est. completion date: December 6, 2022
• Est. primary completion date: December 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Infections
• SARS-CoV-2 Infection

Intervention

Drug:
• HH-120 nasal spray 1
HH-120 nasal spray 5 times daily for 3 consecutive days
• HH-120 nasal spray 2
HH-120 nasal spray 8 times daily for 3 consecutive days
• Placebo Comparator 1
Placebo nasal spray 5 times daily for 3 consecutive days
• Placebo Comparator 2
Placebo nasal spray 8 times daily for 3 consecutive days

Locations

Country	Name	City	State
China	Beijing Ditan Hospital,Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Ditan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects who have a RT-qPCR confirmed SARS-CoV-2 infection.		Day 1 to Day 10
Secondary	Proportion of subjects who have a symptomatic RT-qPCR confirmed SARS-CoV-2 infection.		Day 1 to Day 10
Secondary	Proportion of subjects who have an asymptomatic RT-qPCR confirmed SARS-CoV-2 infection.		Day 1 to Day 10