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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

Sponsor
Beijing Ditan Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05765279
Collaborator
(none)
281
Enrollment
1
Location
4
Arms
1.5
Actual Duration (Months)
182
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: HH-120 nasal spray 1
  • Drug: HH-120 nasal spray 2
  • Drug: Placebo Comparator 1
  • Drug: Placebo Comparator 2
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
281 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
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
Actual Study Start Date :
Oct 20, 2022
Actual Primary Completion Date :
Dec 6, 2022
Actual Study Completion Date :
Dec 6, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Proportion of subjects who have a RT-qPCR confirmed SARS-CoV-2 infection. [Day 1 to Day 10]

Secondary Outcome Measures

  1. Proportion of subjects who have a symptomatic RT-qPCR confirmed SARS-CoV-2 infection. [Day 1 to Day 10]

  2. Proportion of subjects who have an asymptomatic RT-qPCR confirmed SARS-CoV-2 infection. [Day 1 to Day 10]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Ditan Hospital,Capital Medical University Beijing Beijing China 100015

Sponsors and Collaborators

  • Beijing Ditan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ronghua Jin, Professor, Beijing Ditan Hospital
ClinicalTrials.gov Identifier:
NCT05765279
Other Study ID Numbers:
  • HH120-NS02
First Posted:
Mar 13, 2023
Last Update Posted:
Mar 13, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Infections
COVID-19

Study Results

No Results Posted as of Mar 13, 2023