A Study To Assess The Efficacy and Safety of HH-120 Nasal Spray for the Treatment of Mild COVID-19
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Assess the Efficacy and Safety of HH-120 Nasal Spray for the Treatment of Mild COVID-19
1 other identifier
interventional
200
1 country
16
Brief Summary
This is a randomized, double-blind, placebo-controlled Phase 2 study in participants over the age of 18 years with mild COVID-19. The main purpose of this study is to evaluate the effect on viral load clearance and clinical recovery, and safety of HH-120 nasal spray in participants over the age of 18 years with mild COVID-19 (according to the FDA definition, 2021).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 covid19
Started Jan 2023
Shorter than P25 for phase_2 covid19
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 18, 2023
CompletedFirst Submitted
Initial submission to the registry
January 31, 2023
CompletedFirst Posted
Study publicly available on registry
February 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 19, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 19, 2023
CompletedOctober 10, 2024
October 1, 2024
5 months
January 31, 2023
October 8, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Changes of viral load compared to the baseline
From baseline to Day 7
Secondary Outcomes (4)
Time to sustained clinical recovery of 11 COVID-19 symptoms.
From baseline till Day 28
Changes of viral load compared to the baseline.
From baseline till Day 28
Proportion of participants with moderate, severe, critical COVID-19 disease or death.
From baseline till Day 28
Safety assessment: including adverse events, serious adverse events (SAEs), laboratory assessments, etc.
From baseline till Day 28
Study Arms (4)
Treatment Group 1
EXPERIMENTALTreatment Group 2
EXPERIMENTALControl Group 3
PLACEBO COMPARATORControl Group 4
PLACEBO COMPARATORInterventions
Nasal spray daily doses of HH-120 4 times added on SOC for 6 consecutive days.
Nasal spray daily doses of placebo 4 times added on SOC for 6 consecutive days.
Eligibility Criteria
You may qualify if:
- Participants who are ≥18 years of age .
- Participants who are diagnosed with mild COVID-19 and with Laboratory confirmed of SARS-CoV-2 infection as determined by PCR or antigen test.
- Participants who agree to use highly effective methods of contraception. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test result.
- Participants who are willing and able to provide written informed consent, or with a legal representative who can provide informed consent.
You may not qualify if:
- Have suspected or proven serious disease (cardiovascular, renal, liver systems, etc.), active bacterial, fungal, viral, or other infection (except COVID 19) that in the opinion of the Investigator could constitute a risk when taking the study intervention.
- Bronchial asthma or chronic obstructive pulmonary disease （COPD).
- Urgent or expected need for nasal high-flow oxygen therapy or positive pressure ventilation, invasive mechanical ventilation or Extracorporeal membrane oxygenation(ECMO).
- Have prior use (unless required as rescue medication) of any of the following treatments: COVID 19 investigational or Emergency Use Authorization (EUA) approved treatment, including but not limited to convalescent plasma, mAbs against SARS CoV 2, intravenous immune globulin (IVIG) (any indication), where prior use is defined as the past 30 days or less than 5 half lives of the investigational product (whichever is longer) from Screening.
- History of anaphylaxis or other significant allergy in the opinion of the PI or known allergy or hypersensitivity to any of the components of the study intervention.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Huahui Healthlead
Study Sites (16)
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100015, China
Beijing Friendship Hospital,Capital Medical University
Beijing, Beijing Municipality, 100050, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
Mengchao Hepatobiliary Hospital Of Fujian Medical University
Fuzhou, Fujian, 350025, China
The People's Hospital of Gaozhou
Gaozhou, Guangdong, 525200, China
Nanfang Hospital,Southern Medical University
Guangzhou, Guangdong, 510515, China
Xiangtan Central Hospital
Xiangtan, Hunan, 411100, China
Lianyungang Oriental Hospital
Lianyungang, Jiangsu, 222042, China
Yixing People's Hospital
Wuxi, Jiangsu, 214200, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
Panjin Liaoyou Gem flower Hospital
Panjin, Liaoning, 124000, China
Linfen Central Hospital
Linfen, Shanxi, 041000, China
Chengdu Second People's Hospital
Chengdu, Sichuan, 610017, China
Qujing First People's Hospital
Qujing, Yunan, 100000, China
Southern Central Hospital Of Yunnan Province(The First People's Hospital Of Honghe State)
Yisa, Yunnan, 661199, China
Wenzhou Traditional Chinese Medicine Hospital
Wenzhou, Zhejiang, 325000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2023
First Posted
February 6, 2023
Study Start
January 18, 2023
Primary Completion
June 19, 2023
Study Completion
June 19, 2023
Last Updated
October 10, 2024
Record last verified: 2024-10