A Study to Assess the Safety, Tolerability and Preliminary Efficacy of HH-120 for the Treatment of COVID-19

• Sponsor: Huahui Health (Industry)
• Overall Status: Completed
• CT.gov ID: NCT06039163
• Collaborator: (none)
• Enrollment: 37
• Locations: 4
• Arms: 2
• Actual Duration (Months): 5.8
• Patients Per Site: 9.3
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: HH-120; Drug: placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 37 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Apr 16, 2022
• Actual Primary Completion Date: Oct 10, 2022
• Actual Study Completion Date: Oct 10, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: HH-120	Drug: HH-120; Participants randomized to active treatment in escalation phase will receive HH-120 administered via inhalation for 5 consecutive days (Day 1 to Day 5). Planned dose levels to be used for the escalation phase of the study are 50 (BID), 50 (TID), and 100 (BID) mg. The expansion phase will begin once the recommended dose for expansion phase determined, based on safety and preliminary efficacy data from the escalation phase.
Placebo Comparator: placebo	Drug: placebo; Participants randomized to placebo group in escalation and expansion phase will receive placebo administered via inhalation for 5 consecutive days (Day 1 to Day 5).

Outcome Measures

Primary Outcome Measures

1. 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. [From Baseline to Day 12]

Secondary Outcome Measures

1. 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. [From Baseline to Day 12]

2. 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. [From Baseline to Day 12]

3. Median time to sustained clinical recovery. [From Baseline to Day 12]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Ditan Hospital,Capital Medical University	Beijing	Beijing	China	100015
2	Guangzhou Eighth People's,Guangzhou Medical University	Guangzhou	Guangdong	China	510440
3	The First Hospital of Jilin University	Changchun	Jilin	China	130021
4	Huashan Hospital affiliated to Fudan University	Shanghai	Shanghai	China	200040

Sponsors and Collaborators

• Huahui Health

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Huahui Health
• ClinicalTrials.gov Identifier: NCT06039163
• Other Study ID Numbers: HH120-103
• First Posted: Sep 15, 2023
• Last Update Posted: Sep 15, 2023
• Last Verified: Sep 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Sep 15, 2023