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ENROLLING_BY_INVITATIONPHASE3

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

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

NCT05787418•Huahui Health

View on ClinicalTrials.gov

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.

Eligibility

Age

12 - 85 years

Sex

ALL

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.

Locations (2)

Beijing Ditan Hospital, Capital Medical University

Beijing, China

Huashan Hospital of Fudan University

Shanghai, China

Key Dates

Start Date

March 31, 2023

Primary Completion Date

December 31, 2025

Completion Date

April 1, 2026

Last Updated

October 10, 2024

Enrollment

1,200

ESTIMATED participants

Conditions

COVID-19

Interventions

HH-120 Nasal Spray

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 10, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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