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

NCT05747677 | Completed

• 1 other identifier: HH120-IIT-NS01
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19; SARS-CoV-2 Infection

Outcome Measures

Primary Outcomes (1)

• The proportion of subjects infected with SARS-CoV-2

  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

  As of the 7th day after the last study drug administration

Study Arms (1)

HH-120 Nasal Spray

EXPERIMENTAL

Drug: HH-120 Nasal Spray

Interventions

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.

HH-120 Nasal Spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Ditan Hospital: lead

Study Sites (1)

Beijing Ditan Hospital,Capital Medical University

Beijing, Beijing Municipality, 100015, China

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: February 28, 2023
• Study Start: June 14, 2022
• Primary Completion: February 6, 2023
• Study Completion: February 6, 2023
• Last Updated: February 28, 2023

Record last verified: 2023-02

Locations

CN (1)