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Evaluate the Efficacy and Safety of FB2001 for Inhalation in Patients With Mild to Moderate COVID-19

Primary Purpose

Mild to Moderate COVID-19

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
FB2001
FB2001 placebo
Sponsored by
Frontier Biotechnologies Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild to Moderate COVID-19 focused on measuring severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), FB2001, Coronavirus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥18 years, male or female; Confirmed SARS-CoV-2 infection as determined by Reverse Transcription - Polymerase Chain Reaction(RT -PCR) in any specimen collected within 5 days prior to randomization. Note: RT-PCR is the preferred method; however, with evolving approaches to laboratory confirmation of SARS-CoV-2 infection, other molecular or antigen tests that detect viral RNA or protein are allowed if authorized for use in the country; Patients with mild or moderate COVID-19. Initial onset of signs/symptoms attributable to COVID -19 within 3 days prior to the day of randomization and at least one of the specified signs/symptoms attributable to COVID -19 present on the day of randomization; Women of childbearing potential who have a negative serum or urine pregnancy test prior to the first study dose; Patient who is willing to cooperate and able to participate in the trial, adhered to all requirements of the protocol, and provided written informed consent. Exclusion Criteria: Patients who are currently or are expected to potentially progress to severe/critical COVID-19 within 48 h of randomization; Patients with chronic respiratory diseases, including bronchial asthma and chronic obstructive pulmonary disease etc. Known history of moderate-severe liver impairment (e.g., Child-Pugh grade B or C, alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 5x upper limit normal (ULN) , or acute liver failure within 6 months prior to screening;. Known history of severe renal impairment (e.g., Chronic Kidney Disease-Improved Prediction Equations(CKD-EPI)formula based on serum creatinine, estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2), or was receiving renal replacement therapy, such as peritoneal dialysis or hemodialysis, within 6 months prior to screening; Impaired immune system (including patients treated with systemic corticosteroids or other immunosuppressive agents, or cancer progression or recurrence) Suspected or confirmed concurrent active systemic infections other than COVID-19 that may interfere with the assessment of response to study interventions. Need for radiotherapy, chemotherapy, emergency surgery or surgical treatment at screening, or other emergencies (e.g. acute coronary syndrome, acute pulmonary embolism, etc.). Patients with a history of cardiopulmonary resuscitation or major surgery within 30 days prior to randomization, and patients with other potentially life-threatening clinical conditions or other emergencies. History of hypersensitivity or other contraindications to any component of the study intervention. Patients who received or expected to receive anti-SARS-CoV-2 viral drugs (e.g., nirmatrelvir/ritonavir, molnupiravir, etc.) within 14 days prior to randomization. Have received (within 30 days prior to randomization or within 5 half-lives, whichever is longer) or expect to receive COVID-19 monoclonal antibody or recovery COVID-19 plasma therapy. Any SARS-CoV-2 vaccination within 3 months prior to randomization. Within 28 days or 5 half-lives (whichever is longer) prior to randomization or in clinical studies with other investigational drugs or devices, including studies for COVID-19. Mental illnesses that, in the judgment of the investigator, are not appropriate for participation in this study. Any other situation that the investigator believes may affect the subject's informed consent or adherence to the protocol, or the subject's participation in the study may affect the outcome of the study or his or her own safety, in the investigator's judgment.

Sites / Locations

  • Shenzhen Third People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

FB2001 group

Placebo group

Arm Description

FB2001 will be administered by nebulized inhalation, plus Standard Of Care(SOC)

Placebo will be administered by nebulized inhalation, plus Standard Of Care(SOC)

Outcomes

Primary Outcome Measures

Time to sustained recovery of COVID-19-related signs/symptoms
Sustained recovery of a COVID-19-related sign/symptom is defined as a COVID-19-related sign/symptom score of 0 for 3 consecutive days, i.e., disappearance of COVID-19-related symptoms or return to the status prior to the onset of COVID-19.

Secondary Outcome Measures

Proportion of participants who have progression of COVID-19 .
Disease progression is defined as disease severity from mild to moderate or severe or critical, or moderate to severe or critical, or all-cause death
Time to sustained alleviation of COVID-19-related sign/symptom.
Sustained alleviation of COVID-19-related signs/symptoms are defined as the COVID-19-related sign/symptom score from 0 or 1 to 0 at baseline or from 2 or 3 to 1 or 0 at baseline for 3 consecutive days.
Time to sustained recovery of 5 key COVID-19-related sign/symptom
Sustained recovery of a COVID-19-related sign/symptom is defined as a COVID-19-related sign/symptom score of 0 for 3 consecutive days, i.e., disappearance of COVID-19-related symptoms or return to the status prior to the onset of COVID-19.
Time to sustained alleviation of 5 key COVID-19-related sign/symptom
Sustained alleviation of COVID-19-related signs/symptoms are defined as the COVID-19-related sign/symptom score from 0 or 1 to 0 at baseline or from 2 or 3 to 1 or 0 at baseline for 3 consecutive days.
Proportion of participants who experience sustained recovery of COVID-19 sign/symptom
no special description
Proportion of participants who experience sustained alleviation of COVID-19-related sign/symptom
no special description
Duration of each targeted COVID-19-related sign/symptom.
no special description
Time to sustained virus clearance of SARS-CoV-2 in nasopharyngeal swabs
no special description
Changes in SARS-CoV-2 viral load
no special description
Change in EQ-5D-5L index score
The Euroquol Quality of Life 5-Dimension 5-Level Scale(EQ-5D-5L) index score consists of five dimensions: mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. Each dimension has five scales: no difficulty, a little difficulty, moderate difficulty, severe difficulty, and very severe difficulty

Full Information

First Posted
January 2, 2023
Last Updated
January 4, 2023
Sponsor
Frontier Biotechnologies Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05675072
Brief Title
Evaluate the Efficacy and Safety of FB2001 for Inhalation in Patients With Mild to Moderate COVID-19
Official Title
A Phase II/III,Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of FB2001 for Inhalation in Patients With Mild to Moderate COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 4, 2023 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Frontier Biotechnologies Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is a double-blind,randomized,placebo-controlled study to evaluate the efficacy and safety of FB2001 for Inhalation in patients with mild to moderate Coronavirus Disease 2019(COVID-19). A total of about 1336 subjects are planned to be enrolled. The subjects will be randomized in a 1:1 ratio to FB2001 group or placebo group while both receiving standard of care treatment.
Detailed Description
Coronavirus Disease 2019 (COVID -19) is a respiratory illness that can spread from person to person. The infectious agent that causes COVID -19 is a novel coronavirus, named severe acute respiratory syndrome coronavirus 2(SARS-CoV-2), was first identified during a recent outbreak in December 2019, Patients with COVID-19 have symptoms of fever, cough, and shortness of breath along with non-specific symptoms including myalgia and fatigue. FB2001 is a small-molecule inhibitor of coronavirus 3CL protease(3CLpro). In phase I clinical trial, FB2001 for Inhalation were safe and tolerable well in healthy subjects, and were projected to be effective in patients according to its pharmacokinetic profile. This study is a double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of FB2001 for Inhalation in patients with mild to moderate Coronavirus Disease 2019 (COVID-19). The subjects will be randomized in a 1:1 ratio to FB2001 group or placebo group while both receiving standard of care treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild to Moderate COVID-19
Keywords
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), FB2001, Coronavirus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1336 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FB2001 group
Arm Type
Experimental
Arm Description
FB2001 will be administered by nebulized inhalation, plus Standard Of Care(SOC)
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo will be administered by nebulized inhalation, plus Standard Of Care(SOC)
Intervention Type
Drug
Intervention Name(s)
FB2001
Other Intervention Name(s)
FB2001 for Inhalation
Intervention Description
FB2001 for Inhalation will be reconstituted with normal saline prior to nebulized inhalation. FB2001 will be administered by nebulized inhalation.
Intervention Type
Drug
Intervention Name(s)
FB2001 placebo
Other Intervention Name(s)
placebo
Intervention Description
FB2001 placebo will be reconstituted with normal saline prior to nebulized inhalation. FB2001 placebo will be administered by nebulized inhalation.
Primary Outcome Measure Information:
Title
Time to sustained recovery of COVID-19-related signs/symptoms
Description
Sustained recovery of a COVID-19-related sign/symptom is defined as a COVID-19-related sign/symptom score of 0 for 3 consecutive days, i.e., disappearance of COVID-19-related symptoms or return to the status prior to the onset of COVID-19.
Time Frame
Up to Day 29
Secondary Outcome Measure Information:
Title
Proportion of participants who have progression of COVID-19 .
Description
Disease progression is defined as disease severity from mild to moderate or severe or critical, or moderate to severe or critical, or all-cause death
Time Frame
Up to Day 29
Title
Time to sustained alleviation of COVID-19-related sign/symptom.
Description
Sustained alleviation of COVID-19-related signs/symptoms are defined as the COVID-19-related sign/symptom score from 0 or 1 to 0 at baseline or from 2 or 3 to 1 or 0 at baseline for 3 consecutive days.
Time Frame
Up to Day 29
Title
Time to sustained recovery of 5 key COVID-19-related sign/symptom
Description
Sustained recovery of a COVID-19-related sign/symptom is defined as a COVID-19-related sign/symptom score of 0 for 3 consecutive days, i.e., disappearance of COVID-19-related symptoms or return to the status prior to the onset of COVID-19.
Time Frame
Up to Day 29
Title
Time to sustained alleviation of 5 key COVID-19-related sign/symptom
Description
Sustained alleviation of COVID-19-related signs/symptoms are defined as the COVID-19-related sign/symptom score from 0 or 1 to 0 at baseline or from 2 or 3 to 1 or 0 at baseline for 3 consecutive days.
Time Frame
Up to Day 29
Title
Proportion of participants who experience sustained recovery of COVID-19 sign/symptom
Description
no special description
Time Frame
Day 3 to Day 21
Title
Proportion of participants who experience sustained alleviation of COVID-19-related sign/symptom
Description
no special description
Time Frame
Day 3 to Day 21
Title
Duration of each targeted COVID-19-related sign/symptom.
Description
no special description
Time Frame
Up to Day 29
Title
Time to sustained virus clearance of SARS-CoV-2 in nasopharyngeal swabs
Description
no special description
Time Frame
Up to Day 29
Title
Changes in SARS-CoV-2 viral load
Description
no special description
Time Frame
Up to Day 29
Title
Change in EQ-5D-5L index score
Description
The Euroquol Quality of Life 5-Dimension 5-Level Scale(EQ-5D-5L) index score consists of five dimensions: mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. Each dimension has five scales: no difficulty, a little difficulty, moderate difficulty, severe difficulty, and very severe difficulty
Time Frame
Up to Day 29
Other Pre-specified Outcome Measures:
Title
Incidence and severity of Treatment-Emergent Adverse Events(TEAEs)
Description
safety evaluation
Time Frame
Up to Day 29
Title
Incidence of withdrawals due to Adverse Events(AEs)
Description
safety evaluation
Time Frame
Up to Day 29
Title
Incidence of Serious Adverse Events(SAEs)
Description
safety evaluation
Time Frame
Up to Day 29
Title
Safety as determined by abnormality in haematology
Description
Measurement of white blood cell (WBC) count, red blood cell (RBC) count, haemoglobin (Hb), neutrophils absolute count, lymphocytes absolute count, monocytes absolute count, eosinophils absolute count, Platelets absolute count.
Time Frame
Up to Day 29
Title
Safety as determined by abnormality in clinical chemistry
Description
Measurement of sodium, potassium, urea/blood urea nitrogen (BUN), creatinine, albumin, calcium, phosphate, glucose, c-reactive protein (CRP), alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transpeptidase (GGT), total bilirubin, conjugated bilirubin, creatine kinase.
Time Frame
Up to Day 29
Title
Incidence of treatment-related grade 3 or above TEAEs
Description
safety evaluation
Time Frame
Up to Day 29
Title
Safety as determined by abnormality in urinalysis
Description
Measurement of glucose, protein, blood and microscopy.
Time Frame
Up to Day 29
Title
Safety as determined by abnormality in Coagulation.
Description
Measurement of international normalised ratio (INR), prothrombin time, activated partial thrombin time (aPTT).
Time Frame
Up to Day 29
Title
Incidence of treatment-related adverse events (TRAEs)
Description
safety evaluation
Time Frame
Up to Day 29
Title
Incidence of discontinuation of study treatment due to TEAEs
Description
safety evaluation
Time Frame
Up to Day 29
Title
Incidence of abnormal 12-lead electrocardiogram (ECG)
Description
Results for P wave PR interval, QRS duration, QT interval, QTcF interval, RR interval, and heart rate will be analyzed.
Time Frame
Up to Day 29
Title
Safety as determined by abnormal vital signs (blood pressure, pulse rate, body temperature, and respiratory rate)
Description
Measurement of systolic blood pressure (mm Hg), diastolic blood pressure (mm Hg), pulse rate (beats per minute), body temperature (in degree Celsius), respiratory rate (breaths per minute).
Time Frame
Up to Day 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years, male or female; Confirmed SARS-CoV-2 infection as determined by Reverse Transcription - Polymerase Chain Reaction(RT -PCR) in any specimen collected within 5 days prior to randomization. Note: RT-PCR is the preferred method; however, with evolving approaches to laboratory confirmation of SARS-CoV-2 infection, other molecular or antigen tests that detect viral RNA or protein are allowed if authorized for use in the country; Patients with mild or moderate COVID-19. Initial onset of signs/symptoms attributable to COVID -19 within 3 days prior to the day of randomization and at least one of the specified signs/symptoms attributable to COVID -19 present on the day of randomization; Women of childbearing potential who have a negative serum or urine pregnancy test prior to the first study dose; Patient who is willing to cooperate and able to participate in the trial, adhered to all requirements of the protocol, and provided written informed consent. Exclusion Criteria: Patients who are currently or are expected to potentially progress to severe/critical COVID-19 within 48 h of randomization; Patients with chronic respiratory diseases, including bronchial asthma and chronic obstructive pulmonary disease etc. Known history of moderate-severe liver impairment (e.g., Child-Pugh grade B or C, alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 5x upper limit normal (ULN) , or acute liver failure within 6 months prior to screening;. Known history of severe renal impairment (e.g., Chronic Kidney Disease-Improved Prediction Equations(CKD-EPI)formula based on serum creatinine, estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2), or was receiving renal replacement therapy, such as peritoneal dialysis or hemodialysis, within 6 months prior to screening; Impaired immune system (including patients treated with systemic corticosteroids or other immunosuppressive agents, or cancer progression or recurrence) Suspected or confirmed concurrent active systemic infections other than COVID-19 that may interfere with the assessment of response to study interventions. Need for radiotherapy, chemotherapy, emergency surgery or surgical treatment at screening, or other emergencies (e.g. acute coronary syndrome, acute pulmonary embolism, etc.). Patients with a history of cardiopulmonary resuscitation or major surgery within 30 days prior to randomization, and patients with other potentially life-threatening clinical conditions or other emergencies. History of hypersensitivity or other contraindications to any component of the study intervention. Patients who received or expected to receive anti-SARS-CoV-2 viral drugs (e.g., nirmatrelvir/ritonavir, molnupiravir, etc.) within 14 days prior to randomization. Have received (within 30 days prior to randomization or within 5 half-lives, whichever is longer) or expect to receive COVID-19 monoclonal antibody or recovery COVID-19 plasma therapy. Any SARS-CoV-2 vaccination within 3 months prior to randomization. Within 28 days or 5 half-lives (whichever is longer) prior to randomization or in clinical studies with other investigational drugs or devices, including studies for COVID-19. Mental illnesses that, in the judgment of the investigator, are not appropriate for participation in this study. Any other situation that the investigator believes may affect the subject's informed consent or adherence to the protocol, or the subject's participation in the study may affect the outcome of the study or his or her own safety, in the investigator's judgment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yue Zhang
Phone
+86 02569760330
Email
lczhangyue@frontierbiotech.com
First Name & Middle Initial & Last Name or Official Title & Degree
Cheng Yao
Email
yaocheng@frontierbiotech.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheng Yao
Organizational Affiliation
Frontier Biotechnologies Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Shenzhen Third People's Hospital
City
Shenzhen
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Shu
First Name & Middle Initial & Last Name & Degree
Hongzhou Lu

12. IPD Sharing Statement

Learn more about this trial

Evaluate the Efficacy and Safety of FB2001 for Inhalation in Patients With Mild to Moderate COVID-19

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