HH-120 Nasal Spray for Post-exposure Prevention of SARS-CoV-2
- Summary
- This study will assess the efficacy of HH-120 nasal spray in participants for the post-exposure prevention of SARS-CoV-2.
- Short title
- 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Enrolling by invitation
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2026-04-01
- First posted
- 2023-03-28
- Registry last updated
- 2024-10-10
- Primary completion date
- 2025-12-31
- Start date
- 2023-03-31
- Participants
- 1,200
- Participant count basis
- Estimated
- Planned participants
- 1,200
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Huahui Health
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05787418
- ClinicalTrials.gov ID
- NCT05787418
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
The incidence of symptomatic SARS-CoV-2 infection
Timeframe: 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
The incidence of SARS-CoV-2 infection
Timeframe: Up to 7 days
The changes in SARS-CoV-2 viral nucleic acid load
Timeframe: Up to 7 days
The change of viral load by qRT-PCR
Timeframe: Up to 7 days
Incidence and severity of adverse events
Timeframe: Up to 21 days
The incidence of symptomatic SARS-CoV-2 infection
Timeframe: Up to 3 days
The incidence of symptomatic SARS-CoV-2 infection
Timeframe: Up to 5 days
Time to onset of first COVID-19 related symptom
Timeframe: Up to 7 days
Proportion of participants who progress to moderate/severe/critical type of COVID-19 or death
Timeframe: Up to 21 days
The incidence of symptomatic SARS-CoV-2 infection in different subgroups
Timeframe: Up to 7 days
The incidence and titer of antidrug antibody (ADA)
Timeframe: Up to 21 days
- Sex
- All
- Age groups
- Children, Adults, Older adults
- Minimum age
- 12 Years
- Maximum age
- 85 Years
- Healthy volunteers
- No
- 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.
- 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.
- Beijing Ditan Hospital, Capital Medical UniversityBeijing, China
- Huashan Hospital of Fudan UniversityShanghai, China
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- COVID-19 Primary condition