A Study To Assess The Efficacy and Safety of HH-120 Nasal Spray for the Treatment of Mild COVID-19
NCT ID: NCT05713318
Last Updated: 2024-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
200 participants
INTERVENTIONAL
2023-01-18
2023-06-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment Group 1
HH-120 nasal spray
Nasal spray daily doses of HH-120 4 times added on SOC for 6 consecutive days.
Treatment Group 2
HH-120 nasal spray
Nasal spray daily doses of HH-120 8 times added on SOC for 6 consecutive days.
Control Group 3
Placebo Comparator
Nasal spray daily doses of placebo 4 times added on SOC for 6 consecutive days.
Control Group 4
Placebo Comparator
Nasal spray daily doses of placebo 8 times added on SOC for 6 consecutive days.
Interventions
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HH-120 nasal spray
Nasal spray daily doses of HH-120 4 times added on SOC for 6 consecutive days.
HH-120 nasal spray
Nasal spray daily doses of HH-120 8 times added on SOC for 6 consecutive days.
Placebo Comparator
Nasal spray daily doses of placebo 4 times added on SOC for 6 consecutive days.
Placebo Comparator
Nasal spray daily doses of placebo 8 times added on SOC for 6 consecutive days.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Huahui Health
INDUSTRY
Responsible Party
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Locations
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Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Friendship Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Mengchao Hepatobiliary Hospital Of Fujian Medical University
Fuzhou, Fujian, China
The People's Hospital of Gaozhou
Gaozhou, Guangdong, China
Nanfang Hospital,Southern Medical University
Guangzhou, Guangdong, China
Xiangtan Central Hospital
Xiangtan, Hunan, China
Lianyungang Oriental Hospital
Lianyungang, Jiangsu, China
Yixing People's Hospital
Wuxi, Jiangsu, China
The First Hospital of Jilin University
Changchun, Jilin, China
Panjin Liaoyou Gem flower Hospital
Panjin, Liaoning, China
Linfen Central Hospital
Linfen, Shanxi, China
Chengdu Second People's Hospital
Chengdu, Sichuan, China
Qujing First People's Hospital
Qujing, Yunan, China
Southern Central Hospital Of Yunnan Province(The First People's Hospital Of Honghe State)
Yisa, Yunnan, China
Wenzhou Traditional Chinese Medicine Hospital
Wenzhou, Zhejiang, China
Countries
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Other Identifiers
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HH120-NS215
Identifier Type: -
Identifier Source: org_study_id
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