Clinical trial NCT05713318: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: Huahui Health
Sponsor class: INDUSTRY
First posted: 2023-02-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Changes of viral load compared to the baseline
timeFrame: From baseline to Day 7
Secondary outcomes:
measure: Time to sustained clinical recovery of 11 COVID-19 symptoms.
timeFrame: From baseline till Day 28
measure: Changes of viral load compared to the baseline.
timeFrame: From baseline till Day 28
measure: Proportion of participants with moderate, severe, critical COVID-19 disease or death.
timeFrame: From baseline till Day 28
measure: Safety assessment: including adverse events, serious adverse events (SAEs), laboratory assessments, etc.
timeFrame: From baseline till Day 28
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital,Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Fuzhou
country: China
facility: Mengchao Hepatobiliary Hospital Of Fujian Medical University
state: Fujian
city: Gaozhou
country: China
facility: The People's Hospital of Gaozhou
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital,Southern Medical University
state: Guangdong
city: Xiangtan
country: China
facility: Xiangtan Central Hospital
state: Hunan
city: Lianyungang
country: China
facility: Lianyungang Oriental Hospital
state: Jiangsu
city: Wuxi
country: China
facility: Yixing People's Hospital
state: Jiangsu
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Panjin
country: China
facility: Panjin Liaoyou Gem flower Hospital
state: Liaoning
city: Linfen
country: China
facility: Linfen Central Hospital
state: Shanxi
city: Chengdu
country: China
facility: Chengdu Second People's Hospital
state: Sichuan
city: Qujing
country: China
facility: Qujing First People's Hospital
state: Yunan
city: Honghe
country: China
facility: Southern Central Hospital Of Yunnan Province(The First People's Hospital Of Honghe State)
state: Yunnan
city: Wenzhou
country: China
facility: Wenzhou Traditional Chinese Medicine Hospital
state: Zhejiang
Study officials:
References: