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).
Not Provided
Drug: HH-120 nasal spray
Nasal spray daily doses of HH-120 4 times added on SOC for 6 consecutive days.
Drug: HH-120 nasal spray
Nasal spray daily doses of HH-120 8 times added on SOC for 6 consecutive days.
Drug: Placebo Comparator
Nasal spray daily doses of placebo 4 times added on SOC for 6 consecutive days.
Drug: Placebo Comparator
Nasal spray daily doses of placebo 8 times added on SOC for 6 consecutive days.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing, China
Beijing Friendship Hospital,Capital Medical University
Beijing, Beijing, China
Peking University Third Hospital
Beijing, Beijing, 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)
Honghe, Yunnan, China
Wenzhou Traditional Chinese Medicine Hospital
Wenzhou, Zhejiang, China
Xiaoping Chen
+86 010-80766688
chenxiaoping@hhhbio.com
Mengwei Li
+86 010-80766688
limengwei@hhhbio.com
Not Provided