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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05787418
• Other study ID #: HH120-NS311
• Status: Recruiting
• Phase: Phase 3
• Start date: March 31, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: September 2023
• Source: Huahui Health
• Contact: Ning Wu
• Phone: +86 010-80766688
• Email: wuning[@]hhhbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: June 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• HH-120 Nasal Spray
HH-120 nasal spray 8 times per day for 7 consecutive days
• Placebo
Placebo 8 times per day for 7 consecutive days

Locations

Country	Name	City	State
China	Beijing Ditan Hospital, Capital Medical University	Beijing
China	Huashan Hospital of Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huahui Health

Country where clinical trial is conducted

China, 

Outcome

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