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Completed

NCT Number: NCT05747677

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

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.

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Key information

Conditions

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

Age range

18 year and older

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

  • 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.

Treatment and study plan

HH-120 nasal spray

Drug

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 outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Beijing Ditan Hospital

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 28, 2023
Registry last updated
Feb 28, 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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