Exploratory Study of Aerosol Inhalation of FB2001 for Post-exposure Prophylaxis of COVID-19 Close Contacts

NCT ID: NCT05415241

Last Updated: 2022-06-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-09
• Study Completion Date: 2022-12-31

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.

Conditions

Close Contact Transmission

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

FB2001Exploratory

Stage 1 (Exploring the dose): FB2001 once daily for 5 consecutive days. If the drug is well tolerated but efficacy is inadequate, FB2001 BID for 5 consecutive days.

Stage 2 (Sample size expansion): FB2001 once daily or twice daily for 5 consecutive days depending on the result of stage 1.

Group Type: EXPERIMENTAL

FB2001

Intervention Type: DRUG

Stage 1 (Exploring the dose): Twenty participants will be enrolled for aerosol inhalation of FB2001 once daily for 5 consecutive days. If the drug is well tolerated but efficacy is inadequate, another twenty participants will be enrolled for aerosol inhalation of FB2001 BID for 5 consecutive days.

Stage 2 (Sample size expansion): Another twenty participants will be enrolled for aerosol inhalation of FB2001 once daily or twice daily for 5 consecutive days depending on the result of stage 1.

Interventions

FB2001

Stage 1 (Exploring the dose): Twenty participants will be enrolled for aerosol inhalation of FB2001 once daily for 5 consecutive days. If the drug is well tolerated but efficacy is inadequate, another twenty participants will be enrolled for aerosol inhalation of FB2001 BID for 5 consecutive days.

Stage 2 (Sample size expansion): Another twenty participants will be enrolled for aerosol inhalation of FB2001 once daily or twice daily for 5 consecutive days depending on the result of stage 1.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Frontier Biotechnologies Inc.

INDUSTRY

Sponsor Role: collaborator

Shanghai Center for Disease Control and Prevention

OTHER

Sponsor Role: collaborator

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jieming QU

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Jieming Qu, PhD

Role: CONTACT

jmqu0906@163.com

0086-021-64370045

Yanping Xu, PhD

Role: CONTACT

Other Identifiers

FB2001-PEP-1

Identifier Type: -

Identifier Source: org_study_id