A Study To Assess The Efficacy and Safety of HH-120 Nasal Spray for the Treatment of Mild COVID-19

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05713318
• Other study ID #: HH120-NS215
• Status: Recruiting
• Phase: Phase 2
• Start date: January 18, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2023
• Source: Huahui Health
• Contact: Xiaoping Chen
• Phone: +86 010-80766688
• Email: chenxiaoping[@]hhhbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	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	The First Hospital of Jilin University	Changchun	Jilin
China	Chengdu Second People's Hospital	Chengdu	Sichuan
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	Southern Central Hospital Of Yunnan Province(The First People's Hospital Of Honghe State)	Honghe	Yunnan
China	Lianyungang Oriental Hospital	Lianyungang	Jiangsu
China	Linfen Central Hospital	Linfen	Shanxi
China	Panjin Liaoyou Gem flower Hospital	Panjin	Liaoning
China	Qujing First People's Hospital	Qujing	Yunan
China	Wenzhou Traditional Chinese Medicine Hospital	Wenzhou	Zhejiang
China	Yixing People's Hospital	Wuxi	Jiangsu
China	Xiangtan Central Hospital	Xiangtan	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Huahui Health

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of viral load compared to the baseline		From baseline to Day 7
Secondary	Time to sustained clinical recovery of 11 COVID-19 symptoms.		From baseline till Day 28
Secondary	Changes of viral load compared to the baseline.		From baseline till Day 28
Secondary	Proportion of participants with moderate, severe, critical COVID-19 disease or death.		From baseline till Day 28
Secondary	Safety assessment: including adverse events, serious adverse events (SAEs), laboratory assessments, etc.		From baseline till Day 28