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A Study of HH-120 Nasal Spray in Close Contacts of Those Diagnosed With COVID-19

Primary Purpose

COVID-19, SARS-CoV-2 Infection

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
HH-120 Nasal Spray
Sponsored by
Beijing Ditan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male and female subjects aged 18 or above; Caregivers of hospitalized children who are infected with SARS-CoV-2; Negative qRT-PCR nucleic acid test result during the screening; Willing and able to give written informed consent. Exclusion Criteria: Those who have child-bearing plan or are unable to voluntarily take effective contraceptive measures, or plan to donate sperm/ovum during the study or within 3 months after the end of the study; Female subjects who are positive for human chorionic gonadotropin (β-Human Chorionic Gonadotropin, β-HCG) or are breastfeeding; Have used antiviral drugs with a therapeutic effect on COVID-19 within 3 months before screening, including various monoclonal antibodies (tixagevimab and cilgavimab, tocilizumab, ambavirumab and romisvir, Bamlanivimab, Etesevimab, Bebtelovimab, Casirivimab and imdevimab, Sotrovimab), convalescent plasma, hydroxychloroquine, Paxlovid (Nimatevir/ritonavir), Azvudine, Baricitinib, molnupiravir, remdesivir, interference drug, ribavirin, arbidol and lopinavir, etc.; (except those with the wash-out time longer than 5 half-lives); Those who have participated in clinical trials of SARS-CoV-2 neutralizing antibodies or participated in clinical trials of other drugs within 4 weeks before screening; Those who have a history of severe allergies or are sensitive to inhaled allergens; or are known to be sensitive to the ingredients of the study drug, other monoclonal antibody drugs, and therapeutic protein preparations (fresh or frozen plasma, human serum albumin, cytokines, interleukin, etc.) Factors, etc.) have allergies or hypersensitivity reactions; Those who have received the COVID-19 vaccine within 2 weeks before the study drug administration or plan to receive the COVID-19 vaccine during the study; Those who cannot tolerate with nasal spray treatment; Any other circumstances that the researchers deemed not suitable for participating in the study.

Sites / Locations

  • Beijing Ditan Hospital,Capital Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HH-120 Nasal Spray

Arm Description

Outcomes

Primary Outcome Measures

The proportion of subjects infected with SARS-CoV-2

Secondary Outcome Measures

The incidence and severity of adverse events and the serious adverse events

Full Information

First Posted
February 24, 2023
Last Updated
February 26, 2023
Sponsor
Beijing Ditan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05747677
Brief Title
A Study of HH-120 Nasal Spray in Close Contacts of Those Diagnosed With COVID-19
Official Title
A Single-Arm Clinical Study Evaluating the Efficacy of Post-Exposure Prophylaxis , Safety, and Tolerability of HH-120 Nasal Spray in Close Contacts of SARS-CoV-2
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 14, 2022 (Actual)
Primary Completion Date
February 6, 2023 (Actual)
Study Completion Date
February 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Ditan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study is to evaluate the efficacy of post-exposure prevention and safety of HH-120 nasal spray in participants who are caregivers of hospitalized patients infected with SARS-CoV-2. HH-120 nasal spray are administrated 8-10 times to the participants per day until the discharge of the SARS-CoV-2 infected patients or confirmed infection of the participant, whichever occurs first.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, SARS-CoV-2 Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HH-120 Nasal Spray
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
HH-120 Nasal Spray
Intervention Description
HH-120 nasal spray, 1 spray to each nostril of the participant each time,8-10 times per day, until the discharge of the SARS-CoV-2 infected patients or confirmed infection of the participant, whichever occurs first.
Primary Outcome Measure Information:
Title
The proportion of subjects infected with SARS-CoV-2
Time Frame
As of the discharge of the SARS-CoV-2 infected patients, an average 1 week
Secondary Outcome Measure Information:
Title
The incidence and severity of adverse events and the serious adverse events
Time Frame
As of the 7th day after the last study drug administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female subjects aged 18 or above; Caregivers of hospitalized children who are infected with SARS-CoV-2; Negative qRT-PCR nucleic acid test result during the screening; Willing and able to give written informed consent. Exclusion Criteria: Those who have child-bearing plan or are unable to voluntarily take effective contraceptive measures, or plan to donate sperm/ovum during the study or within 3 months after the end of the study; Female subjects who are positive for human chorionic gonadotropin (β-Human Chorionic Gonadotropin, β-HCG) or are breastfeeding; Have used antiviral drugs with a therapeutic effect on COVID-19 within 3 months before screening, including various monoclonal antibodies (tixagevimab and cilgavimab, tocilizumab, ambavirumab and romisvir, Bamlanivimab, Etesevimab, Bebtelovimab, Casirivimab and imdevimab, Sotrovimab), convalescent plasma, hydroxychloroquine, Paxlovid (Nimatevir/ritonavir), Azvudine, Baricitinib, molnupiravir, remdesivir, interference drug, ribavirin, arbidol and lopinavir, etc.; (except those with the wash-out time longer than 5 half-lives); Those who have participated in clinical trials of SARS-CoV-2 neutralizing antibodies or participated in clinical trials of other drugs within 4 weeks before screening; Those who have a history of severe allergies or are sensitive to inhaled allergens; or are known to be sensitive to the ingredients of the study drug, other monoclonal antibody drugs, and therapeutic protein preparations (fresh or frozen plasma, human serum albumin, cytokines, interleukin, etc.) Factors, etc.) have allergies or hypersensitivity reactions; Those who have received the COVID-19 vaccine within 2 weeks before the study drug administration or plan to receive the COVID-19 vaccine during the study; Those who cannot tolerate with nasal spray treatment; Any other circumstances that the researchers deemed not suitable for participating in the study.
Facility Information:
Facility Name
Beijing Ditan Hospital,Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100015
Country
China

12. IPD Sharing Statement

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A Study of HH-120 Nasal Spray in Close Contacts of Those Diagnosed With COVID-19

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