Clinical trial NCT05747677: A Study of HH-120 Nasal Spray in Close Contacts of Those Diagnosed With COVID-19
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
SARS-CoV-2 Infection
Lead sponsor: Beijing Ditan Hospital
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of subjects infected with SARS-CoV-2
timeFrame: As of the discharge of the SARS-CoV-2 infected patients, an average 1 week
Secondary outcomes:
measure: The incidence and severity of adverse events and the serious adverse events
timeFrame: As of the 7th day after the last study drug administration
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospital,Capital Medical University
state: Beijing
Study officials:
References: