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Completed

NCT Number: NCT05713318

A Study To Assess The Efficacy and Safety of HH-120 Nasal Spray for the Treatment of Mild COVID-19

This is a randomized, double-blind, placebo-controlled Phase 2 study in participants over the age of 18 years with mild COVID-19. The main purpose of this study is to evaluate the effect on viral load clearance and clinical recovery, and safety of HH-120 nasal spray in participants over the age of 18 years with mild COVID-19 (according to the FDA definition, 2021).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Ditan Hospital, Capital Medical University, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants who are ≥18 years of age .
  • Participants who are diagnosed with mild COVID-19 and with Laboratory confirmed of SARS-CoV-2 infection as determined by PCR or antigen test.
  • Participants who agree to use highly effective methods of contraception. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test result.
  • Participants who are willing and able to provide written informed consent, or with a legal representative who can provide informed consent.

Exclusion criteria

  • Have suspected or proven serious disease (cardiovascular, renal, liver systems, etc.), active bacterial, fungal, viral, or other infection (except COVID 19) that in the opinion of the Investigator could constitute a risk when taking the study intervention.
  • Bronchial asthma or chronic obstructive pulmonary disease (COPD).
  • Urgent or expected need for nasal high-flow oxygen therapy or positive pressure ventilation, invasive mechanical ventilation or Extracorporeal membrane oxygenation(ECMO).
  • Have prior use (unless required as rescue medication) of any of the following treatments: COVID 19 investigational or Emergency Use Authorization (EUA) approved treatment, including but not limited to convalescent plasma, mAbs against SARS CoV 2, intravenous immune globulin (IVIG) (any indication), where prior use is defined as the past 30 days or less than 5 half lives of the investigational product (whichever is longer) from Screening.
  • History of anaphylaxis or other significant allergy in the opinion of the PI or known allergy or hypersensitivity to any of the components of the study intervention.

Treatment and study plan

HH-120 nasal spray

Drug

Nasal spray daily doses of HH-120 4 times added on SOC for 6 consecutive days.

placebo comparator

Drug

Nasal spray daily doses of placebo 4 times added on SOC for 6 consecutive days.

Primary outcomes

  1. Changes of viral load compared to the baseline

    Time frame: From baseline to Day 7

Secondary outcomes

  1. Time to sustained clinical recovery of 11 COVID-19 symptoms.

    Time frame: From baseline till Day 28

  2. Changes of viral load compared to the baseline.

    Time frame: From baseline till Day 28

  3. Proportion of participants with moderate, severe, critical COVID-19 disease or death.

    Time frame: From baseline till Day 28

  4. Safety assessment: including adverse events, serious adverse events (SAEs), laboratory assessments, etc.

    Time frame: From baseline till Day 28

Sponsors and collaborators

Lead sponsor

Huahui Health

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Assess the Efficacy and Safety of HH-120 Nasal Spray for the Treatment of Mild COVID-19

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 6, 2023
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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