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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05659602

Enrollment

111

Registered

2022-12-21

Start date

2022-07-09

Completion date

2023-01-03

Last updated

2024-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus Disease 2019(COVID-19)

Keywords

COVID-19, Treatment

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.

Interventions

BIOLOGICALHH-120 Nasal Spray

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Other

Measure	Time frame	Description
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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026