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

• Sponsor: Beijing Ditan Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05659602
• Collaborator: (none)
• Enrollment: 77
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 11.7
• Patients Per Site Per Month: 6.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Coronavirus Disease 2019(COVID-19)	Biological: HH-120 Nasal Spray	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 77 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official 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
• Actual Study Start Date: Jul 9, 2022
• Anticipated Primary Completion Date: Mar 30, 2023
• Anticipated Study Completion Date: Jun 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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). [Up to 12 days]

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

2. 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

1. 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.

2. Viral load. [Up to 12 days]

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

3. Adverse event. [Up to 12 days]

   Incidence and severity of adverse events.

Other Outcome Measures

1. Proportion of the participants who have progression of COVID-19. [Up to 12 days]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Ditan Hospital, Capital Medical University	Beijing		China

Sponsors and Collaborators

• Beijing Ditan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ronghua Jin, Chief Physician, Beijing Ditan Hospital
• ClinicalTrials.gov Identifier: NCT05659602
• Other Study ID Numbers: HH120-IIT-NS05
• First Posted: Dec 21, 2022
• Last Update Posted: Dec 21, 2022
• Last Verified: Dec 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ronghua Jin, Chief Physician, Beijing Ditan Hospital: COVID-19, treatment
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Dec 21, 2022