Status:
COMPLETED
A Study to Assess the Safety, Tolerability and Preliminary Efficacy of HH-120 for the Treatment of COVID-19
Lead Sponsor:
Huahui Health
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 pre...
Eligibility Criteria
Inclusion
- The escalation phase:
- Participants are aged 18 to 65 years (inclusive at the time of informed consent)
- Participants are mild or moderate COVID-19 patients.
- 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:
- Participants are ≥18 years of age at the time of randomization.
- Participants are mild or moderate COVID-19 patients.
- 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
- 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.
Key Trial Info
Start Date :
April 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2022
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT06039163
Start Date
April 16 2022
End Date
October 10 2022
Last Update
September 15 2023
Active Locations (4)
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1
Beijing Ditan Hospital,Capital Medical University
Beijing, Beijing Municipality, 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 Municipality, China, 200040