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

Sponsor

Huahui Health (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05713318

Collaborator

(none)

200

Enrollment

Locations

Arms

17.4

Anticipated Duration (Months)

13.3

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: HH-120 nasal spray Drug: HH-120 nasal spray Drug: Placebo Comparator Drug: Placebo Comparator	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 18, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Group 1	Drug: HH-120 nasal spray Nasal spray daily doses of HH-120 4 times added on SOC for 6 consecutive days.
Experimental: Treatment Group 2	Drug: HH-120 nasal spray Nasal spray daily doses of HH-120 8 times added on SOC for 6 consecutive days.
Placebo Comparator: Control Group 3	Drug: Placebo Comparator Nasal spray daily doses of placebo 4 times added on SOC for 6 consecutive days.
Placebo Comparator: Control Group 4	Drug: Placebo Comparator Nasal spray daily doses of placebo 8 times added on SOC for 6 consecutive days.

Outcome Measures

Primary Outcome Measures

Changes of viral load compared to the baseline [From baseline to Day 7]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Ditan Hospital, Capital Medical University	Beijing	Beijing	China	100015
2	Beijing Friendship Hospital,Capital Medical University	Beijing	Beijing	China	100050
3	Mengchao Hepatobiliary Hospital Of Fujian Medical University	Fuzhou	Fujian	China	350025
4	The People's Hospital of Gaozhou	Gaozhou	Guangdong	China	525200
5	Nanfang Hospital,Southern Medical University	Guangzhou	Guangdong	China	510515
6	Xiangtan Central Hospital	Xiangtan	Hunan	China	411100
7	Lianyungang Oriental Hospital	Lianyungang	Jiangsu	China	222042
8	Yixing People's Hospital	Wuxi	Jiangsu	China	214200
9	Dalian Municipal Central Hospital	Dalian	Liaoning	China	116033
10	Panjin Liaoyou Gem flower Hospital	Panjin	Liaoning	China	124000
11	Linfen Central Hospital	Linfen	Shanxi	China	041000
12	Qujing First People's Hospital	Qujing	Yunan	China	100000
13	Southern Central Hospital Of Yunnan Province(The First People's Hospital Of Honghe State)	Honghe	Yunnan	China	661199
14	Anning First People's Hospital	Kunming	Yunnan	China	650300
15	Wenzhou Traditional Chinese Medicine Hospital	Wenzhou	Zhejiang	China	325000

Sponsors and Collaborators

Huahui Health

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Huahui Health

ClinicalTrials.gov Identifier:

NCT05713318

Other Study ID Numbers:

HH120-NS215

First Posted:

Feb 6, 2023

Last Update Posted:

Feb 6, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Feb 6, 2023