COVID-19
Conditions
Keywords
Severe Acute Respiratory Syndrome Coronavirus 2, Coronavirus disease 2019
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.
Interventions
HH-120 nasal spray 8 times per day for 7 consecutive days
DRUGPlacebo
Placebo 8 times per day for 7 consecutive days
Sponsors
Huahui Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 SARS-CoV-2 infection | 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 |
| Time to onset of first COVID-19 related symptom | Up to 7 days |
Countries
China
Outcome results
None listed