Clinical trial NCT05415241: Exploratory Study of Aerosol Inhalation of FB2001 for Post-exposure Prophylaxis of COVID-19 Close Contacts
Official title: Exploratory Study of Aerosol Inhalation of FB2001 for Post-exposure Prophylaxis of Close Contacts of COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Close Contact Transmission
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Frontier Biotechnologies Inc.
name: Shanghai Center for Disease Control and Prevention
First posted: 2022-06-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: This is a single-arm, open-label, dose ramp-up exploratory clinical trial to evaluate the efficacy, safety and tolerance of aerosol inhalation of FB2001 as post-exposure prophylaxis among close contacts of COVID-19 patients.

This study will enroll 20 to 60 close contacts of COVID-19 patients aging 18 to 65 years.

After signing the informed consent form, the qualified subjects will be given FB2001 once or twice daily.


Eligibility criteria: Inclusion Criteria:

1. Male or female individuals aged 18-65 years.
2. COVID-19 close contacts determined by epidemiological investigation (living in the same room within 72 hours before screening with individuals having positive nucleic acid amplification test for SARS-CoV-2 ).
3. Having two consecutive negative nucleic acid tests within 72 hours before enrollment.
4. Participants of childbearing age must agree to use a highly effective method of contraception.
5. Sign the informed consent form.

Exclusion Criteria:

1. Pregnant women.
2. Participants who have history of prior drug allergy or are vulnerable to allergy.
3. Participants who infected with SARS-CoV-2 within previous 6 months.
4. Fever (body temperature \> 38 ℃), frequent cough and other symptoms suggestive of COVID-19 upon screening.
5. Participants with a history of asthma or chronic obstructive pulmonary disease.
6. Participants with known history of active liver disease, acute kidney disease or chronic kidney disease.
7. Participants with known history of stroke (except cavity infarction), serious heart disease or myocardial infarction.
8. Participants with known diagnosis of Alzheimer's disease, Parkinson's disease or tumor (except for radical tumor resection).
9. Blood pressure \>180/100mmHg at screening.
10. Participated in other interventional studies within previous 6 months.
11. Uptaking CYP3A4/5 strong inducers or inhibitors (rifampicin, phenytoin, carbamazepine, St. John's wort, clarithromycin, itraconazole, ketoconazole, ritonavir, cobicistat, darunavir, atazanavir, lopinavir, nelmatevir, nefazodone, etc.).
12. Participants who need to use other anti-SARS-CoV-2 therapeutic drugs during the study period.
13. Other conditions are considered unsuitable to participate in the researcher after evaluation by the researcher.

Primary outcomes:
measure: efficacy index of post-exposure prophylaxis against COVID-19
timeFrame: 7 days post aerosol inhalation of FB2001
measure: efficacy index of post-exposure prophylaxis against COVID-19
timeFrame: 14 days post aerosol inhalation of FB2001
measure: safety index
timeFrame: during aerosol inhalation of FB2001 or 30 minutes (or longer, if necessary) post aerosol inhalation of FB2001
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: