SARS-CoV-2 Infection
Conditions
Brief summary
An Investigator-initiated, Randomized, Single-Blind, Placebo-Controlled Trial to Evaluate the Efficacy of SARS-Cov-2 Post Exposure Prophylaxis and Safety of HH-120 nasal spray
Interventions
DRUGHH-120 nasal spray 1
HH-120 nasal spray 5 times daily for 3 consecutive days
DRUGHH-120 nasal spray 2
HH-120 nasal spray 8 times daily for 3 consecutive days
DRUGPlacebo Comparator 1
Placebo nasal spray 5 times daily for 3 consecutive days
DRUGPlacebo Comparator 2
Placebo nasal spray 8 times daily for 3 consecutive days
Sponsors
Beijing Ditan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Participants aged 18 to 65 years. * Participants who have close contact with a SARS-CoV-2 infected individual (index case) are required to be randomized within 72 hours upon close contact. * Willing and able to provide written informed consent, or with a legal representative who can provide informed consent.
Exclusion criteria
* Have a history of severe allergy or hyper-sensitivity to inhaled allergen. * Pregnant or breastfeeding women. * Have participated, within the last 180 days prior to the screening, in a clinical study involving an investigational intervention of SARS-CoV-2 neutralizing antibody. * Have other conditions not suitable for the study per investigator's discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects who have a RT-qPCR confirmed SARS-CoV-2 infection. | Day 1 to Day 10 |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects who have a symptomatic RT-qPCR confirmed SARS-CoV-2 infection. | Day 1 to Day 10 |
| Proportion of subjects who have an asymptomatic RT-qPCR confirmed SARS-CoV-2 infection. | Day 1 to Day 10 |
Countries
China
Outcome results
None listed