Official Title
A Phase III, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of HH-120 Nasal Spray for Post-exposure Prophylaxis of SARS-CoV-2
Brief Summary

This study will assess the efficacy of HH-120 nasal spray in participants for thepost-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.

Enrolling by invitation
COVID-19

Drug: HH-120 Nasal Spray

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

Drug: Placebo

Placebo 8 times per day for 7 consecutive days

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.

Eligibility Gender
All
Eligibility Age
Minimum: 12 Years ~ Maximum: 85 Years
Countries
China
Locations

Beijing Ditan Hospital, Capital Medical University
Beijing, China

Huashan Hospital of Fudan University
Shanghai, China

Not Provided

Huahui Health
NCT Number
Keywords
Severe acute respiratory syndrome coronavirus 2
Coronavirus disease 2019