Clinical trial NCT05787418: HH-120 Nasal Spray for Post-exposure Prevention of SARS-CoV-2
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: COVID-19
Keywords: Severe Acute Respiratory Syndrome Coronavirus 2
Coronavirus disease 2019
Lead sponsor: Huahui Health
Sponsor class: INDUSTRY
First posted: 2023-03-28
Enrollment: 1200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.

Primary outcomes:
measure: The incidence of symptomatic SARS-CoV-2 infection
timeFrame: Up to 7 days
Secondary outcomes:
measure: The incidence of SARS-CoV-2 infection
timeFrame: Up to 7 days
measure: The changes in SARS-CoV-2 viral nucleic acid load
timeFrame: Up to 7 days
measure: The change of viral load by qRT-PCR
timeFrame: Up to 7 days
measure: Incidence and severity of adverse events
timeFrame: Up to 21 days
measure: The incidence of symptomatic SARS-CoV-2 infection
timeFrame: Up to 3 days
measure: The incidence of symptomatic SARS-CoV-2 infection
timeFrame: Up to 5 days
measure: Time to onset of first COVID-19 related symptom
timeFrame: Up to 7 days
measure: Proportion of participants who progress to moderate/severe/critical type of COVID-19 or death
timeFrame: Up to 21 days
measure: The incidence of symptomatic SARS-CoV-2 infection in different subgroups
timeFrame: Up to 7 days
measure: The incidence and titer of antidrug antibody (ADA)
timeFrame: Up to 21 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospital, Capital Medical University
city: Shanghai
country: China
facility: Huashan Hospital of Fudan University
Study officials:
References: