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

Primary Purpose

COVID-19

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
HH-120 nasal spray
HH-120 nasal spray
Placebo Comparator
Placebo Comparator
Sponsored by
Huahui Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Beijing Ditan Hospital, Capital Medical UniversityRecruiting
  • Beijing Friendship Hospital,Capital Medical UniversityRecruiting
  • Peking University Third HospitalRecruiting
  • Mengchao Hepatobiliary Hospital Of Fujian Medical UniversityRecruiting
  • The People's Hospital of GaozhouRecruiting
  • Nanfang Hospital,Southern Medical UniversityRecruiting
  • Xiangtan Central HospitalRecruiting
  • Lianyungang Oriental HospitalRecruiting
  • Yixing People's HospitalRecruiting
  • The First Hospital of Jilin UniversityRecruiting
  • Panjin Liaoyou Gem flower HospitalRecruiting
  • Linfen Central HospitalRecruiting
  • Chengdu Second People's HospitalRecruiting
  • Qujing First People's HospitalRecruiting
  • Southern Central Hospital Of Yunnan Province(The First People's Hospital Of Honghe State)Recruiting
  • Wenzhou Traditional Chinese Medicine HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

Treatment Group 1

Treatment Group 2

Control Group 3

Control Group 4

Arm Description

Outcomes

Primary Outcome Measures

Changes of viral load compared to the baseline

Secondary Outcome Measures

Time to sustained clinical recovery of 11 COVID-19 symptoms.
Changes of viral load compared to the baseline.
Proportion of participants with moderate, severe, critical COVID-19 disease or death.
Safety assessment: including adverse events, serious adverse events (SAEs), laboratory assessments, etc.

Full Information

First Posted
January 31, 2023
Last Updated
May 14, 2023
Sponsor
Huahui Health
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1. Study Identification

Unique Protocol Identification Number
NCT05713318
Brief Title
A Study To Assess The Efficacy and Safety of HH-120 Nasal Spray for the Treatment of Mild COVID-19
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Huahui Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group 1
Arm Type
Experimental
Arm Title
Treatment Group 2
Arm Type
Experimental
Arm Title
Control Group 3
Arm Type
Placebo Comparator
Arm Title
Control Group 4
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
HH-120 nasal spray
Intervention Description
Nasal spray daily doses of HH-120 4 times added on SOC for 6 consecutive days.
Intervention Type
Drug
Intervention Name(s)
HH-120 nasal spray
Intervention Description
Nasal spray daily doses of HH-120 8 times added on SOC for 6 consecutive days.
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator
Intervention Description
Nasal spray daily doses of placebo 4 times added on SOC for 6 consecutive days.
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator
Intervention Description
Nasal spray daily doses of placebo 8 times added on SOC for 6 consecutive days.
Primary Outcome Measure Information:
Title
Changes of viral load compared to the baseline
Time Frame
From baseline to Day 7
Secondary Outcome Measure Information:
Title
Time to sustained clinical recovery of 11 COVID-19 symptoms.
Time Frame
From baseline till Day 28
Title
Changes of viral load compared to the baseline.
Time Frame
From baseline till Day 28
Title
Proportion of participants with moderate, severe, critical COVID-19 disease or death.
Time Frame
From baseline till Day 28
Title
Safety assessment: including adverse events, serious adverse events (SAEs), laboratory assessments, etc.
Time Frame
From baseline till Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoping Chen
Phone
+86 010-80766688
Email
chenxiaoping@hhhbio.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mengwei Li
Phone
+86 010-80766688
Email
limengwei@hhhbio.com
Facility Information:
Facility Name
Beijing Ditan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100015
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Friendship Hospital,Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Name
Mengchao Hepatobiliary Hospital Of Fujian Medical University
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350025
Country
China
Individual Site Status
Recruiting
Facility Name
The People's Hospital of Gaozhou
City
Gaozhou
State/Province
Guangdong
ZIP/Postal Code
525200
Country
China
Individual Site Status
Recruiting
Facility Name
Nanfang Hospital,Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Name
Xiangtan Central Hospital
City
Xiangtan
State/Province
Hunan
ZIP/Postal Code
411100
Country
China
Individual Site Status
Recruiting
Facility Name
Lianyungang Oriental Hospital
City
Lianyungang
State/Province
Jiangsu
ZIP/Postal Code
222042
Country
China
Individual Site Status
Recruiting
Facility Name
Yixing People's Hospital
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214200
Country
China
Individual Site Status
Recruiting
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Name
Panjin Liaoyou Gem flower Hospital
City
Panjin
State/Province
Liaoning
ZIP/Postal Code
124000
Country
China
Individual Site Status
Recruiting
Facility Name
Linfen Central Hospital
City
Linfen
State/Province
Shanxi
ZIP/Postal Code
041000
Country
China
Individual Site Status
Recruiting
Facility Name
Chengdu Second People's Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610017
Country
China
Individual Site Status
Recruiting
Facility Name
Qujing First People's Hospital
City
Qujing
State/Province
Yunan
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Name
Southern Central Hospital Of Yunnan Province(The First People's Hospital Of Honghe State)
City
Honghe
State/Province
Yunnan
ZIP/Postal Code
661199
Country
China
Individual Site Status
Recruiting
Facility Name
Wenzhou Traditional Chinese Medicine Hospital
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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