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NCT Number: NCT05659602

A Clinical Study to Assess Preliminary Efficacy, Safety and Tolerability of HH-120 Nasal Spray in COVID-19 Patients

To evaluate the preliminary efficacy and safety of HH-120 nasal spray in the treatment of asymptomatic or mild COVID-19.

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Key information

Conditions

Coronavirus Disease 2019(COVID-19) COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Ditan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

About this study

During this study, participants will receive HH-120 nasal spray treatment for 6 consecutive days, the efficacy and safety of HH-120 will be assessed throughout the study period based on viral clearance, clinical recovery, illness severity and adverse events.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 to 65 years old.
  • Participants with mild COVID-19 with symptom onset≤5 days or asymptomatic COVID-19.
  • Participants being able and willing to provide informed consent prior to any study-specific procedure.

Exclusion criteria

  • Participants with moderate or severe COVID-19.
  • Participants within the pregnancy or breastfeeding period or plan to be pregnant during the study period.
  • Participants requiring oxygen treatment (such as non-invasive ventilation, invasive mechanical ventilation, ECMO, etc.).
  • Participants with nasal disease that is inconvenient or intolerant of nasal spray administration, or cannot use the nasal spray treatment.
  • Participants with comorbid Malignancy or with a history of malignancy.
  • Participants with active or uncontrolled systemic autoimmune disease.
  • Insufficient function of key organs.
  • Other reasons considered by the investigator to be unsuitable for the trial.

Treatment and study plan

HH-120 Nasal Spray

Biological

HH-120 Nasal Spray 8-10 times per day for 6 consecutive days

Primary outcomes

  1. Time to achieving SARS-CoV-2 clearance (defined as negative quantitative Real-Time polymerase chain reaction [qRT-PCR] tests taken on two consecutive days).

    Time frame: Up to 12 days

    Median time from first dose to achieving SARS-COV-2 clearance.

  2. Proportion of participants with SARS-CoV-2 clearance.

    Time frame: Up to 12 days

    Proportion of participants achieving SARS-CoV-2 clearance from the first dose until Day 12.

Secondary outcomes

  1. Clinical recovery of COVID-19.

    Time frame: Up to 12 days

    Time to sustained COVID-19 symptoms recovery; Time to COVID-19 symptoms improvement; Proportion of participants with sustained COVID-19 symptoms recovery; Proportion of participants with COVID-19 symptoms improvement.

  2. Viral load.

    Time frame: Up to 12 days

    Change of CT values of N gene and ORF1 gene (qRT-PCR) from baseline.

  3. Adverse event.

    Time frame: Up to 12 days

    Incidence and severity of adverse events.

Other outcomes

  1. Proportion of the participants who have progression of COVID-19.

    Time frame: Up to 12 days

    Proportion of participants who progress to moderate/severe/critical type of COVID-19 illness.

Sponsors and collaborators

Lead sponsor

Beijing Ditan Hospital

Other

Registry information

Official study title

A Clinical Study to Assess Preliminary Efficacy, Safety and Tolerability of HH-120 Nasal Spray in Participants Diagnosed With Asymptomatic or Mild COVID-19

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 21, 2022
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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