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

COMPLETEDPHASE2

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

NCT05713318•Huahui Health

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

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.

Locations (16)

Beijing Ditan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing Friendship Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Peking University Third Hospital

Beijing, Beijing Municipality, 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

Key Dates

Start Date

January 18, 2023

Primary Completion Date

June 19, 2023

Completion Date

June 19, 2023

Last Updated

October 10, 2024

Enrollment

200

ACTUAL participants

Conditions

COVID-19

Interventions

HH-120 nasal spray

DRUG

HH-120 nasal spray

DRUG

Placebo Comparator

DRUG

Placebo Comparator

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 10, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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