Official Title
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
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).

Detailed Description

Not Provided

Recruiting
COVID-19

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.

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
China
Locations

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

Contacts

Xiaoping Chen
+86 010-80766688
chenxiaoping@hhhbio.com

Mengwei Li
+86 010-80766688
limengwei@hhhbio.com

Not Provided

Huahui Health
NCT Number
MeSH Terms
COVID-19