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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Close Contact Transmission
• Intervention / Treatment: Drug: FB2001

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Jieming Qu, PhD; Phone Number: 0086-021-64370045; Email: jmqu0906@163.com
• Study Contact Backup: Name: Yanping Xu, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
efficacy index of post-exposure prophylaxis against COVID-19	The percentage of participants having positive nucleic acid amplification test for SARS-CoV-2 within 7 days post inhalation of FB2001.	7 days post aerosol inhalation of FB2001
efficacy index of post-exposure prophylaxis against COVID-19	The percentage of participants having positive nucleic acid amplification test for SARS-CoV-2 within 14 days post inhalation of FB2001.	14 days post aerosol inhalation of FB2001
safety index	The number of cases of intolerance or anaphylaxis, as well as the incidence of treatment-related adverse events (TRAEs) during aerosol inhalation therapy.	during aerosol inhalation of FB2001 or 30 minutes (or longer, if necessary) post aerosol inhalation of FB2001

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Collaborators: Frontier Biotechnologies Inc.; Shanghai Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Anticipated): June 9, 2022
• Primary Completion (Anticipated): August 9, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: June 9, 2022
• First Submitted That Met QC Criteria: June 10, 2022
• First Posted (Actual): June 13, 2022

Study Record Updates

• Last Update Posted (Actual): June 13, 2022
• Last Update Submitted That Met QC Criteria: June 10, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: FB2001-PEP-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No