Status:
UNKNOWN
Exploratory Study of Aerosol Inhalation of FB2001 for Post-exposure Prophylaxis of COVID-19 Close Contacts
Lead Sponsor:
Ruijin Hospital
Collaborating Sponsors:
Frontier Biotechnologies Inc.
Shanghai Center for Disease Control and Prevention
Conditions:
Close Contact Transmission
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
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 contac...
Eligibility Criteria
Inclusion
- Male or female individuals aged 18-65 years.
- 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 ).
- Having two consecutive negative nucleic acid tests within 72 hours before enrollment.
- Participants of childbearing age must agree to use a highly effective method of contraception.
- Sign the informed consent form.
Exclusion
- Pregnant women.
- Participants who have history of prior drug allergy or are vulnerable to allergy.
- Participants who infected with SARS-CoV-2 within previous 6 months.
- Fever (body temperature \> 38 ℃), frequent cough and other symptoms suggestive of COVID-19 upon screening.
- Participants with a history of asthma or chronic obstructive pulmonary disease.
- Participants with known history of active liver disease, acute kidney disease or chronic kidney disease.
- Participants with known history of stroke (except cavity infarction), serious heart disease or myocardial infarction.
- Participants with known diagnosis of Alzheimer's disease, Parkinson's disease or tumor (except for radical tumor resection).
- Blood pressure \>180/100mmHg at screening.
- Participated in other interventional studies within previous 6 months.
- 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.).
- Participants who need to use other anti-SARS-CoV-2 therapeutic drugs during the study period.
- Other conditions are considered unsuitable to participate in the researcher after evaluation by the researcher.
Key Trial Info
Start Date :
June 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05415241
Start Date
June 9 2022
End Date
December 31 2022
Last Update
June 13 2022
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