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Enrolling by invitation NCT05787418

HH-120 Nasal Spray for Post-exposure Prevention of SARS-CoV-2

Phase III Interventional COVID-19

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HH-120 Nasal Spray, Placebo.
Who it may be relevant to
Registry conditions: COVID-19. Basic parameters: 12 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase III, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of HH-120 Nasal Spray for Post-exposure Prophylaxis of SARS-CoV-2

Overview

This study will assess the efficacy of HH-120 nasal spray in participants for the post-exposure prevention of SARS-CoV-2.

Detailed description

During this study, participants will receive HH-120 nasal spray treatment for 7 consecutive days, the efficacy and safety of HH-120 nasal spray will be assessed throughout the study period mainly based on the incidence of symptomatic SARS-CoV-2 infection and adverse events, respectively.

Interventions

  • Drug HH-120 Nasal Spray
    HH-120 nasal spray 8 times per day for 7 consecutive days
  • Drug Placebo
    Placebo 8 times per day for 7 consecutive days

Primary outcome measures

  • The incidence of symptomatic SARS-CoV-2 infection [Time frame: Up to 7 days]
Secondary outcome measures (10)
  • The incidence of SARS-CoV-2 infection [Time frame: Up to 7 days]
  • The changes in SARS-CoV-2 viral nucleic acid load [Time frame: Up to 7 days]
  • The change of viral load by qRT-PCR [Time frame: Up to 7 days]
  • Incidence and severity of adverse events [Time frame: Up to 21 days]
  • The incidence of symptomatic SARS-CoV-2 infection [Time frame: Up to 3 days]
  • The incidence of symptomatic SARS-CoV-2 infection [Time frame: Up to 5 days]
  • Time to onset of first COVID-19 related symptom [Time frame: Up to 7 days]
  • Proportion of participants who progress to moderate/severe/critical type of COVID-19 or death [Time frame: Up to 21 days]
  • The incidence of symptomatic SARS-CoV-2 infection in different subgroups [Time frame: Up to 7 days]
  • The incidence and titer of antidrug antibody (ADA) [Time frame: Up to 21 days]

Eligibility criteria

Inclusion criteria

  • 12 to 85 years old.
  • Participants with potential exposure to index patients (with known positive result of qRT-PCR or rapid antigen test \[RAT\]).
  • Participants will be randomized no longer than 48 hours from the onset of the COVID-19 related symptom of the index patients.
  • Participants with a negative RAT result within 2 hours prior to randomization.
  • Fertile participants must agree to use a highly effective method of contraception.
  • Participants being able and willing to provide informed consent prior to any study-specific procedure.

Exclusion criteria

  • Those with high risk of cardiac events, or severe abnormal functions of liver, kidney, lung, brain and other organs and are deemed as unsuitable to participate in the study (except for those subjects with kidney failure but received regular dialysis, or those with liver dysfunction but stabilized after treatment evaluated by the evaluation of the investigators).
  • Those comorbid with asthma.
  • Those with a history of SARS-CoV-2 infection within 3 months prior to randomization.
  • Those who has received any nasal spray or aerosol inhalation COVID-19 vaccine within 3 months prior to randomization.
  • Those who experienced symptom of upper respiratory tract infection within 2 weeks prior to randomization, such as nasal congestion, sore throat, shortness of breath (dyspnea), cough, fatigue, fever, headache, etc.
  • Known history of allergy or reaction to any component of the study drug formulation.
  • Those who has received other treatment with anti-COVID-19 indication (within 1 month or 5 half-life period prior to randomization, whichever occurs first).
  • Participants with nasal disease that is inconvenient or intolerant of nasal spray administration.
  • Other reasons considered by the investigator to be unsuitable for the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

China · 2 centers
  • Beijing Ditan Hospital, Capital Medical University — Beijing
  • Huashan Hospital of Fudan University — Shanghai

Identifiers

NCT: NCT05787418 · HH120-NS311

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗