HH-120 Nasal Spray for Post-exposure Prevention of SARS-CoV-2

NCT ID: NCT05787418

Last Updated: 2024-10-10

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE3
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-31
• Study Completion Date: 2026-04-01

Brief Summary

This study will assess the efficacy of HH-120 nasal spray in participants for the post-exposure prevention of SARS-CoV-2.

Detailed Description

During this study, participants will receive HH-120 nasal spray treatment for 7 consecutive days, the efficacy and safety of HH-120 nasal spray will be assessed throughout the study period mainly based on the incidence of symptomatic SARS-CoV-2 infection and adverse events, respectively.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

HH-120 group

HH-120 Nasal Spray

Group Type: EXPERIMENTAL

HH-120 Nasal Spray

Intervention Type: DRUG

HH-120 nasal spray 8 times per day for 7 consecutive days

Control group

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo 8 times per day for 7 consecutive days

Interventions

HH-120 Nasal Spray

HH-120 nasal spray 8 times per day for 7 consecutive days

Intervention Type: DRUG

Placebo

Placebo 8 times per day for 7 consecutive days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 12 to 85 years old.
• Participants with potential exposure to index patients (with known positive result of qRT-PCR or rapid antigen test [RAT]).
• Participants will be randomized no longer than 48 hours from the onset of the COVID-19 related symptom of the index patients.
• Participants with a negative RAT result within 2 hours prior to randomization.
• Fertile participants must agree to use a highly effective method of contraception.
• Participants being able and willing to provide informed consent prior to any study-specific procedure.

Exclusion Criteria

• Those with high risk of cardiac events, or severe abnormal functions of liver, kidney, lung, brain and other organs and are deemed as unsuitable to participate in the study (except for those subjects with kidney failure but received regular dialysis, or those with liver dysfunction but stabilized after treatment evaluated by the evaluation of the investigators).
• Those comorbid with asthma.
• Those with a history of SARS-CoV-2 infection within 3 months prior to randomization.
• Those who has received any nasal spray or aerosol inhalation COVID-19 vaccine within 3 months prior to randomization.
• Those who experienced symptom of upper respiratory tract infection within 2 weeks prior to randomization, such as nasal congestion, sore throat, shortness of breath (dyspnea), cough, fatigue, fever, headache, etc.
• Known history of allergy or reaction to any component of the study drug formulation.
• Those who has received other treatment with anti-COVID-19 indication (within 1 month or 5 half-life period prior to randomization, whichever occurs first).
• Participants with nasal disease that is inconvenient or intolerant of nasal spray administration.
• Other reasons considered by the investigator to be unsuitable for the study.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Huahui Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Ditan Hospital, Capital Medical University

Beijing, , China

Huashan Hospital of Fudan University

Shanghai, , China

Countries

China

Other Identifiers

HH120-NS311

Identifier Type: -

Identifier Source: org_study_id