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

Coronavirus Disease 2019(COVID-19) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05659602
• Other study ID #: HH120-IIT-NS05
• Status: Completed
• Phase: N/A
• Start date: July 9, 2022
• Est. completion date: January 3, 2023

Study information

• Verified date: September 2023
• Source: Beijing Ditan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: January 3, 2023
• Est. primary completion date: January 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Disease 2019(COVID-19)
• COVID-19

Intervention

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

Locations

Country	Name	City	State
China	Beijing Ditan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Ditan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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	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
Secondary	Viral load.	Change of CT values of N gene and ORF1 gene (qRT-PCR) from baseline.	Up to 12 days
Secondary	Adverse event.	Incidence and severity of adverse events.	Up to 12 days