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

NCT ID: NCT05659602

Last Updated: 2024-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-09

Study Completion Date

2023-01-03

Brief Summary

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

Detailed Description

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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.

Conditions

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Coronavirus Disease 2019(COVID-19)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HH-120 group

HH-120 Nasal Spray

Group Type EXPERIMENTAL

HH-120 Nasal Spray

Intervention Type BIOLOGICAL

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

Interventions

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HH-120 Nasal Spray

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Ditan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ronghua Jin

Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Ditan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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HH120-IIT-NS05

Identifier Type: -

Identifier Source: org_study_id

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