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

H

Huahui Health

Status and phase

Completed
Phase 1

Conditions

COVID-19

Treatments

Drug: HH-120
Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06039163
HH120-103

Details and patient eligibility

About

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.

Enrollment

37 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

37 participants in 2 patient groups, including a placebo group

HH-120
Active Comparator group
Treatment:
Drug: HH-120
placebo
Placebo Comparator group
Treatment:
Drug: placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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