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Completed

NCT Number: NCT05765279

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

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

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Key information

Conditions

Sars-CoV-2 Infection COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Ditan Hospital,Capital Medical University

Beijing, Beijing Municipality, 100015, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HH-120 nasal spray 1

Drug

HH-120 nasal spray 5 times daily for 3 consecutive days

HH-120 nasal spray 2

Drug

HH-120 nasal spray 8 times daily for 3 consecutive days

Placebo Comparator 1

Drug

Placebo nasal spray 5 times daily for 3 consecutive days

Placebo Comparator 2

Drug

Placebo nasal spray 8 times daily for 3 consecutive days

Primary outcomes

  1. Proportion of subjects who have a RT-qPCR confirmed SARS-CoV-2 infection.

    Time frame: Day 1 to Day 10

Secondary outcomes

  1. Proportion of subjects who have a symptomatic RT-qPCR confirmed SARS-CoV-2 infection.

    Time frame: Day 1 to Day 10

  2. Proportion of subjects who have an asymptomatic RT-qPCR confirmed SARS-CoV-2 infection.

    Time frame: Day 1 to Day 10

Sponsors and collaborators

Lead sponsor

Beijing Ditan Hospital

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 13, 2023
Registry last updated
Mar 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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