A Study to Assess the Efficacy of HH-120 Nasal Spray for Prevention of SARS-CoV-2 Infection in Adult Close Contacts of Individuals Infected With SARS-CoV-2

March 1, 2023 updated by: Ronghua Jin, Beijing Ditan Hospital

An Investigator Initiated Clinical Study To Evaluate the Efficacy and Safety of HH-120 Nasal Spray as Post Exposure Prophylaxis (PEP) Regimen in Adult Close Contacts of Individuals Infected With SARS-CoV-2

An Investigator-initiated, Randomized, Single-Blind, Placebo-Controlled Trial to Evaluate the Efficacy of SARS-Cov-2 Post Exposure Prophylaxis and Safety of HH-120 nasal spray

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

281

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100015
        • Beijing Ditan Hospital,Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants aged 18 to 65 years.
  • Participants who have close contact with a SARS-CoV-2 infected individual (index case) are required to be randomized within 72 hours upon close contact.
  • Willing and able to provide written informed consent, or with a legal representative who can provide informed consent.

Exclusion Criteria:

  • Have a history of severe allergy or hyper-sensitivity to inhaled allergen.
  • Pregnant or breastfeeding women.
  • Have participated, within the last 180 days prior to the screening, in a clinical study involving an investigational intervention of SARS-CoV-2 neutralizing antibody.
  • Have other conditions not suitable for the study per investigator's discretion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group 1
Drug: HH-120 nasal spray 1
HH-120 nasal spray 5 times daily for 3 consecutive days
Experimental: Treatment Group 2
Drug: HH-120 nasal spray 2
HH-120 nasal spray 8 times daily for 3 consecutive days
Placebo Comparator: Control Group 3
Drug: Placebo Comparator 1
Placebo nasal spray 5 times daily for 3 consecutive days
Placebo Comparator: Control Group 4
Drug: Placebo Comparator 2
Placebo nasal spray 8 times daily for 3 consecutive days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects who have a RT-qPCR confirmed SARS-CoV-2 infection.
Time Frame: Day 1 to Day 10
Day 1 to Day 10

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects who have a symptomatic RT-qPCR confirmed SARS-CoV-2 infection.
Time Frame: Day 1 to Day 10
Day 1 to Day 10
Proportion of subjects who have an asymptomatic RT-qPCR confirmed SARS-CoV-2 infection.
Time Frame: Day 1 to Day 10
Day 1 to Day 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Ditan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2022

Primary Completion (Actual)

December 6, 2022

Study Completion (Actual)

December 6, 2022

Study Registration Dates

First Submitted

March 1, 2023

First Submitted That Met QC Criteria

March 1, 2023

First Posted (Actual)

March 13, 2023

Study Record Updates

Last Update Posted (Actual)

March 13, 2023

Last Update Submitted That Met QC Criteria

March 1, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HH120-NS02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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