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

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

Study Overview

• Status: Recruiting
• Conditions: COVID-19
• Intervention / Treatment: Drug: HH-120 Nasal Spray; Drug: Placebo

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 Type: Interventional
• Enrollment (Estimated): 1200
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Mengwei Li; Phone Number: +86 010-80766688; Email: limengwei@hhhbio.com
• Study Contact Backup: Name: Ning Wu; Phone Number: +86 010-80766688; Email: wuning@hhhbio.com

Study Locations

• China
  • Beijing, China, 100000
    • Recruiting
    • Beijing Ditan Hospital, Capital Medical University
  • Shanghai, China, 200000
    • Recruiting
    • Huashan Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 85 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; Placebo	Drug: Placebo; Placebo 8 times per day for 7 consecutive days
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Huahui Health

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: March 27, 2023
• First Submitted That Met QC Criteria: March 27, 2023
• First Posted (Actual): March 28, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Coronavirus disease 2019; Severe Acute Respiratory Syndrome Coronavirus 2
• Other Study ID Numbers: HH120-NS311

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No