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

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

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

Study Overview

• Status: Completed
• Conditions: Coronavirus Disease 2019(COVID-19)
• Intervention / Treatment: Biological: HH-120 Nasal Spray

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HH-120 group; HH-120 Nasal Spray	Biological: HH-120 Nasal Spray; HH-120 Nasal Spray 8-10 times per day for 6 consecutive days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to achieving SARS-CoV-2 clearance (defined as negative quantitative Real-Time polymerase chain reaction [qRT-PCR] tests taken on two consecutive days).	Median time from first dose to achieving SARS-COV-2 clearance.	Up to 12 days
Proportion of participants with SARS-CoV-2 clearance.	Proportion of participants achieving SARS-CoV-2 clearance from the first dose until Day 12.	Up to 12 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical recovery of COVID-19.	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.	Up to 12 days
Viral load.	Change of CT values of N gene and ORF1 gene (qRT-PCR) from baseline.	Up to 12 days
Adverse event.	Incidence and severity of adverse events.	Up to 12 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of the participants who have progression of COVID-19.	Proportion of participants who progress to moderate/severe/critical type of COVID-19 illness.	Up to 12 days

Collaborators and Investigators

• Sponsor: Beijing Ditan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2022
• Primary Completion (Actual): January 3, 2023
• Study Completion (Actual): January 3, 2023

Study Registration Dates

• First Submitted: December 20, 2022
• First Submitted That Met QC Criteria: December 20, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Actual): October 10, 2024
• Last Update Submitted That Met QC Criteria: October 8, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Treatment; COVID-19
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: HH120-IIT-NS05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No