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

Sponsor

Huahui Health (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05787418

Collaborator

(none)

1,200

Enrollment

Locations

Arms

14.2

Anticipated Duration (Months)

600

Patients Per Site

42.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: HH-120 Nasal Spray Drug: Placebo	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

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

Anticipated Study Start Date :

Mar 28, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HH-120 group HH-120 Nasal Spray	Drug: HH-120 Nasal Spray HH-120 nasal spray 8 times per day for 7 consecutive days
Placebo Comparator: Control group Placebo	Drug: Placebo Placebo 8 times per day for 7 consecutive days

Arm

Intervention/Treatment

Experimental: HH-120 group

HH-120 Nasal Spray

Drug: HH-120 Nasal Spray

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

Placebo Comparator: Control group

Placebo

Drug: Placebo

Placebo 8 times per day for 7 consecutive days

Outcome Measures

Primary Outcome Measures

The incidence of symptomatic SARS-CoV-2 infection [Up to 7 days]
Incidence of participants with quantitative Real-Time polymerase chain reaction (qRT-PCR) confirmed SARS-CoV-2 infection and COVID-19 related symptom

Secondary Outcome Measures

The incidence of SARS-CoV-2 infection [Up to 7 days]
The changes in SARS-CoV-2 viral nucleic acid load [Up to 7 days]
The change of viral load by qRT-PCR [Up to 7 days]
Incidence and severity of adverse events [Up to 21 days]
The incidence of symptomatic SARS-CoV-2 infection [Up to 3 days]
The incidence of symptomatic SARS-CoV-2 infection [Up to 5 days]
Time to onset of first COVID-19 related symptom [Up to 7 days]
Proportion of participants who progress to moderate/severe/critical type of COVID-19 or death [Up to 21 days]
The incidence of symptomatic SARS-CoV-2 infection in different subgroups [Up to 7 days]
The incidence and titer of antidrug antibody (ADA) [Up to 21 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Ditan Hospital, Capital Medical University	Beijing		China	100000
2	Huashan Hospital of Fudan University	Shanghai		China	200000

Sponsors and Collaborators

Huahui Health

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Huahui Health

ClinicalTrials.gov Identifier:

NCT05787418

Other Study ID Numbers:

HH120-NS311

First Posted:

Mar 28, 2023

Last Update Posted:

Mar 28, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Huahui Health

Severe Acute Respiratory Syndrome Coronavirus 2

Coronavirus disease 2019

Study Results

No Results Posted as of Mar 28, 2023