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

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

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).

Study Overview

• Status: Recruiting
• Conditions: COVID-19
• Intervention / Treatment: Drug: HH-120 nasal spray; Drug: HH-120 nasal spray; Drug: Placebo Comparator; Drug: Placebo Comparator

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xiaoping Chen; Phone Number: +86 010-80766688; Email: chenxiaoping@hhhbio.com
• Study Contact Backup: Name: Mengwei Li; Phone Number: +86 010-80766688; Email: limengwei@hhhbio.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Peking University Third Hospital
    • Beijing, Beijing, China, 100015
      • Recruiting
      • Beijing Ditan Hospital, Capital Medical University
    • Beijing, Beijing, China, 100050
      • Recruiting
      • Beijing Friendship Hospital,Capital Medical University
  • Fujian
    • Fuzhou, Fujian, China, 350025
      • Recruiting
      • Mengchao Hepatobiliary Hospital of Fujian Medical University
  • Guangdong
    • Gaozhou, Guangdong, China, 525200
      • Recruiting
      • The People's Hospital of Gaozhou
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Nanfang Hospital，Southern Medical University
  • Hunan
    • Xiangtan, Hunan, China, 411100
      • Recruiting
      • Xiangtan Central Hospital
  • Jiangsu
    • Lianyungang, Jiangsu, China, 222042
      • Recruiting
      • Lianyungang Oriental Hospital
    • Wuxi, Jiangsu, China, 214200
      • Recruiting
      • Yixing People's Hospital
  • Jilin
    • Changchun, Jilin, China, 130021
      • Recruiting
      • The First Hospital of Jilin University
  • Liaoning
    • Panjin, Liaoning, China, 124000
      • Recruiting
      • Panjin Liaoyou Gem Flower Hospital
  • Shanxi
    • Linfen, Shanxi, China, 041000
      • Recruiting
      • Linfen Central Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610017
      • Recruiting
      • ChengDu Second People's Hospital
  • Yunan
    • Qujing, Yunan, China, 100000
      • Recruiting
      • Qujing First People's Hospital
  • Yunnan
    • Honghe, Yunnan, China, 661199
      • Recruiting
      • Southern Central Hospital Of Yunnan Province(The First People's Hospital Of Honghe State)
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • Recruiting
      • Wenzhou Traditional Chinese Medicine Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes of viral load compared to the baseline	From baseline to Day 7

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Huahui Health

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2023
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: January 31, 2023
• First Submitted That Met QC Criteria: February 2, 2023
• First Posted (Actual): February 6, 2023

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 14, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: HH120-NS215

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No