A Phase 1 interventional study of HH-120 and placebo in COVID-19, sponsored by Huahui Health. Completed at 4 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-15.
Sponsored by Huahui Health · Phase 1, Interventional, and Treatment
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 37 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Huahui Health is the lead sponsor of 15 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The escalation phase:
The expansion phase:
Exclusion Criteria:
Drug: HH-120
Drug: placebo
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.
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).
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.
Time frame: From Baseline to Day 12
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.
Time frame: From Baseline to Day 12
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.
Time frame: From Baseline to Day 12
Median time to sustained clinical recovery.
Time frame: From Baseline to Day 12
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Huahui Health