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

Capital Medical University

Status

Completed

Conditions

Coronavirus Disease 2019(COVID-19)

Treatments

Biological: HH-120 Nasal Spray

Study type

Interventional

Funder types

Other

Identifiers

NCT05659602

HH120-IIT-NS05

Details and patient eligibility

About

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

Full 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.

Enrollment

111 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.