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

Not Applicable

Completed

• Conditions: Coronavirus Disease 2019(COVID-19)
• Interventions: Biological: HH-120 Nasal Spray

• Registration Number: NCT05659602
• Lead Sponsor: Beijing Ditan Hospital

Brief Summary

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

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 Timeline

• Study Start: 2022-07-09
• Study First Submitted: 2022-12-20
• Study First Submitted QC: 2022-12-20
• Study First Posted: 2022-12-21
• Primary Completion: 2023-01-03
• Study Completion: 2023-01-03
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HH-120 group	HH-120 Nasal Spray	HH-120 Nasal Spray

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Beijing Ditan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China