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

Huahui Health

Status and phase: Invitation-only; Phase 3

Conditions: COVID-19

Treatments: Drug: HH-120 Nasal Spray; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05787418

HH120-NS311

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 12 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,200 participants in 2 patient groups, including a placebo group

HH-120 group

Experimental group

Description:

HH-120 Nasal Spray

Treatment:

Drug: HH-120 Nasal Spray

Control group

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo