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

NCT05659602 | Completed

• 1 other identifier: HH120-IIT-NS05
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronavirus Disease 2019(COVID-19)

Keywords

COVID-19; Treatment

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Clinical recovery of COVID-19.

  Up to 12 days

• Viral load.

  Up to 12 days

• Adverse event.

  Up to 12 days

Other Outcomes (1)

• Proportion of the participants who have progression of COVID-19.

  Up to 12 days

Study Arms (1)

HH-120 group

EXPERIMENTAL

HH-120 Nasal Spray

Biological: HH-120 Nasal Spray

Interventions

HH-120 Nasal Spray BIOLOGICAL

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

HH-120 group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Ditan Hospital: lead

Study Sites (1)

Beijing Ditan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: December 21, 2022
• Study Start: July 9, 2022
• Primary Completion: January 3, 2023
• Study Completion: January 3, 2023
• Last Updated: October 10, 2024

Record last verified: 2024-10

Locations

CN (1)