Clinical trial NCT06039163: A Study to Assess the Safety, Tolerability and Preliminary Efficacy of HH-120 for the Treatment of COVID-19
Official title: A Randomized, Double-blind, Placebo-controlled, Phase 1 Study to Assess the Safety, Tolerability, Preliminary Efficacy of Inhaled HH-120 Aerosol in Participants With Mild to Moderate COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: COVID-19
Lead sponsor: Huahui Health
Sponsor class: INDUSTRY
First posted: 2023-09-15
Enrollment: 37
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 1 study in participants over the age of 18 years with mild to moderate COVID-19. This study aims to assess the safety, tolerability and preliminary antiviral effect of HH-120. This study includes dose escalation phase and dose expansion phase.


Eligibility criteria: Inclusion Criteria:

* The escalation phase:

  1. Participants are aged 18 to 65 years (inclusive at the time of informed consent)
  2. Participants are mild or moderate COVID-19 patients.
  3. Participants have one or more mild or moderate COVID 19-related symptoms as defined by the FDA (see the Diagnosis and Main Criteria for Inclusion) with the onset of symptoms ≤ 3 days prior to the randomization.
* The expansion phase:

  1. Participants are ≥18 years of age at the time of randomization.
  2. Participants are mild or moderate COVID-19 patients.
  3. Participants have one or more mild or moderate COVID 19-related symptoms as defined by the FDA (see the Diagnosis and Main Criteria for Inclusion) with the onset of symptoms ≤ 5 days prior to the randomization.

Exclusion Criteria:

* Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period.
* Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality that, in the PI's (or delegate's) opinion, could adversely affect the safety of the participant or that might interfere with the conduct of the study.
* Presence of any underlying physical or psychological medical condition that, in the opinion of the PI, would make it unlikely that the participant will comply with the protocol or complete the study per protocol.
* Have known allergies to any of the components used in the formulation of the study intervention.

Primary outcomes:
measure: Safety and Tolerability: Incidence, frequency, severity, and duration of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAE) and serious adverse events (SAEs), etc.
timeFrame: From Baseline to Day 12
Secondary outcomes:
measure: Proportion of participants that achieve SARS-CoV-2 clearance (defined as negative qRT-PCR tests taken on two consecutive days), with the time of clearance being the time of the first negative test.
timeFrame: From Baseline to Day 12
measure: Median time to achieve SARS-CoV-2 clearance (defined as negative qRT-PCR tests taken on two consecutive days), with the time of clearance being the time of the first negative test.
timeFrame: From Baseline to Day 12
measure: Median time to sustained clinical recovery.
timeFrame: From Baseline to Day 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospital,Capital Medical University
state: Beijing
city: Guangzhou
country: China
facility: Guangzhou Eighth People's,Guangzhou Medical University
state: Guangdong
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Shanghai
country: China
facility: Huashan Hospital affiliated to Fudan University
state: Shanghai
Study officials:
References: