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

Primary Purpose

Close Contact Transmission

Status

Not yet recruiting

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

FB2001

About this trial

This is an interventional prevention trial for Close Contact Transmission

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FB2001Exploratory

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05415241

First Posted

June 9, 2022

Last Updated

June 10, 2022

Sponsor

Ruijin Hospital

Collaborators

Frontier Biotechnologies Inc., Shanghai Center for Disease Control and Prevention

1. Study Identification

Unique Protocol Identification Number

NCT05415241

Brief Title

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

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

June 9, 2022 (Anticipated)

Primary Completion Date

August 9, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ruijin Hospital

Collaborators

Frontier Biotechnologies Inc., Shanghai Center for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Close Contact Transmission

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

FB2001Exploratory

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

FB2001

Intervention Description

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.

Primary Outcome Measure Information:

Title

efficacy index of post-exposure prophylaxis against COVID-19

Description

The percentage of participants having positive nucleic acid amplification test for SARS-CoV-2 within 7 days post inhalation of FB2001.

Time Frame

7 days post aerosol inhalation of FB2001

Title

efficacy index of post-exposure prophylaxis against COVID-19

Description

The percentage of participants having positive nucleic acid amplification test for SARS-CoV-2 within 14 days post inhalation of FB2001.

Time Frame

14 days post aerosol inhalation of FB2001

Title

safety index

Description

The number of cases of intolerance or anaphylaxis, as well as the incidence of treatment-related adverse events (TRAEs) during aerosol inhalation therapy.

Time Frame

during aerosol inhalation of FB2001 or 30 minutes (or longer, if necessary) post aerosol inhalation of FB2001

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jieming Qu, PhD

Phone

0086-021-64370045

jmqu0906@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Yanping Xu, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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