Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04750278
Status:
TERMINATED
Last Update Posted:
2024-01-05
First Post:
2021-02-02
Brief Title:
A Phase 23 Study to Evaluate FP-025 in Patients With Severe to Critical COVID 19
Sponsor:
Foresee Pharmaceuticals Co Ltd
Organization:
Foresee Pharmaceuticals Co Ltd
Study Overview
Official Title:
A Phase 23 Randomized Double Blind Placebo Controlled Multicenter Study to Evaluate the Efficacy and Safety of FP-025 in Patients With Severe to Critical COVID 19 With Associated Acute Respiratory Distress Syndrome ARDS
Status:
TERMINATED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study stopped at interim analysis point due to lack of study subjects to recruit
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 23 randomized double blind placebo controlled multicenter study to evaluate the efficacy and safety of FP-025 in adult patients with severe to critical COVID 19 with associated ARDS
Detailed Description:
This is a Phase 23 randomized double-blind placebo-controlled multicenter study to evaluate the efficacy and safety of FP-025 in adult patients with severe to critical COVID-19 with associated ARDS The patients in each phase Phase 2 and Phase 3 will be analyzed separately Each phase will consist of a Screening Visit Treatment Period and Follow-Up Period for a total study duration of approximately 60 days
Phase 2 After eligibility is confirmed approximately 90 patients will be randomized in a 111 ratio to receive FP-025 100 mg twice daily BID FP-025 300 mg BID or placebo BID for 28 days During Phase 2 randomized patients will be stratified by the use of invasive mechanical ventilation at the time of randomization yes or no At least one-third of patients should be on invasive mechanical ventilation to ensure that treatment benefits can be assessed for patients at different severity levels
Patients with Grade 3 to Grade 4 heart failure Stage 3 or greater chronic obstructive pulmonary disease persistent asthma and mild liver disease ie Child-Pugh Class A will not be excluded from the study The independent Data Monitoring Committee iDMC will independently monitor safety of the entire population and in different subgroups and may make recommendations as it deems appropriate During Phase 2 no limitation in enrollment of subgroups is expected unless clear safety signals arise in those subgroups during iDMC reviews
The reason for hospital admission the standard of care followed for each patient and center and whether any care decisions were based on resource limitations will be clearly documented for all patients beginning on Day 1 Visit 2 All patients will be allowed to receive standard of care andor emergency use authorization EUA medications and treatment for COVID-19 however the study drug should be discontinued for other non-standard of care concomitant medications used with the intent of directly treating COVID-19 unless there is prior Medical Monitor or Sponsor approval for the patient to remain on the study drug If the use of concomitant medications necessitates study drug discontinuation the patient should be encouraged to remain in the study and to follow-up for key study visits Day 28 and Day 60 but will not be required to attend every study visit If the patient withdraws heshe should complete the Early Termination Visit
Standard of care procedures for mechanical ventilation eg low tidal volume protective mechanical ventilation and standard of care procedures for weaning from mechanical ventilation will be followed
Study drug administration will begin on Day 1 Visit 2 following randomization All patients will receive standard of care andor EUA treatment for COVID-19 in addition to the study drug Patients will continue study drug treatment BID through Day 27 and take 1 dose on Day 28 If a patient is discharged from the hospital prior to Day 28 heshe will continue treatment as an outpatient at home with hisher assigned treatment FP-025 100 mg BID FP-025 300 mg BID or placebo BID until Day 28 Dosing instructions will be provided prior to discharge Although treatment will be identical for inpatients and outpatients patients discharged from the hospital will follow a different Schedule of Procedures characterized by telemedicine or telephone if sites andor patients do not have video capability visits The End of Treatment EOT Visit on Day 28 will be identical for all patients with the exception of the arterial oxygen partial pressure PaO2fractional inspired oxygen FiO2 ratio performed only in patients on invasive or non-invasive ventilation and will include a high-resolution non-contrast CT scan in addition to other assessments
After treatment is completed all patients will undergo 2 follow-up assessments during the Follow-Up Period The first follow-up will be a telephone visit on Day 45 to assess concomitant medications adverse events AEs and the NIAID 8-point ordinal scale for COVID-19 and hospitalization outcomes score The second follow-up will be an in-person visit on Day 60 and will include a high-resolution non-contrast CT scan and pulmonary function tests in addition to other assessments
An iDMC will convene to oversee safety and efficacy assessments during and after the Phase 2 study No formal statistical testing will be conducted In addition when all patients in the Phase 2 study have completed the EOT Visit on Day 28 a primary analysis will be conducted by an independent statistician and reviewed by the iDMC This is the point at which the study was terminated due to lack of further eligible patients
Phase 2 After eligibility is confirmed approximately 90 patients will be randomized in a 111 ratio to receive FP-025 100 mg twice daily BID FP-025 300 mg BID or placebo BID for 28 days During Phase 2 randomized patients will be stratified by the use of invasive mechanical ventilation at the time of randomization yes or no At least one-third of patients should be on invasive mechanical ventilation to ensure that treatment benefits can be assessed for patients at different severity levels
Patients with Grade 3 to Grade 4 heart failure Stage 3 or greater chronic obstructive pulmonary disease persistent asthma and mild liver disease ie Child-Pugh Class A will not be excluded from the study The independent Data Monitoring Committee iDMC will independently monitor safety of the entire population and in different subgroups and may make recommendations as it deems appropriate During Phase 2 no limitation in enrollment of subgroups is expected unless clear safety signals arise in those subgroups during iDMC reviews
The reason for hospital admission the standard of care followed for each patient and center and whether any care decisions were based on resource limitations will be clearly documented for all patients beginning on Day 1 Visit 2 All patients will be allowed to receive standard of care andor emergency use authorization EUA medications and treatment for COVID-19 however the study drug should be discontinued for other non-standard of care concomitant medications used with the intent of directly treating COVID-19 unless there is prior Medical Monitor or Sponsor approval for the patient to remain on the study drug If the use of concomitant medications necessitates study drug discontinuation the patient should be encouraged to remain in the study and to follow-up for key study visits Day 28 and Day 60 but will not be required to attend every study visit If the patient withdraws heshe should complete the Early Termination Visit
Standard of care procedures for mechanical ventilation eg low tidal volume protective mechanical ventilation and standard of care procedures for weaning from mechanical ventilation will be followed
Study drug administration will begin on Day 1 Visit 2 following randomization All patients will receive standard of care andor EUA treatment for COVID-19 in addition to the study drug Patients will continue study drug treatment BID through Day 27 and take 1 dose on Day 28 If a patient is discharged from the hospital prior to Day 28 heshe will continue treatment as an outpatient at home with hisher assigned treatment FP-025 100 mg BID FP-025 300 mg BID or placebo BID until Day 28 Dosing instructions will be provided prior to discharge Although treatment will be identical for inpatients and outpatients patients discharged from the hospital will follow a different Schedule of Procedures characterized by telemedicine or telephone if sites andor patients do not have video capability visits The End of Treatment EOT Visit on Day 28 will be identical for all patients with the exception of the arterial oxygen partial pressure PaO2fractional inspired oxygen FiO2 ratio performed only in patients on invasive or non-invasive ventilation and will include a high-resolution non-contrast CT scan in addition to other assessments
After treatment is completed all patients will undergo 2 follow-up assessments during the Follow-Up Period The first follow-up will be a telephone visit on Day 45 to assess concomitant medications adverse events AEs and the NIAID 8-point ordinal scale for COVID-19 and hospitalization outcomes score The second follow-up will be an in-person visit on Day 60 and will include a high-resolution non-contrast CT scan and pulmonary function tests in addition to other assessments
An iDMC will convene to oversee safety and efficacy assessments during and after the Phase 2 study No formal statistical testing will be conducted In addition when all patients in the Phase 2 study have completed the EOT Visit on Day 28 a primary analysis will be conducted by an independent statistician and reviewed by the iDMC This is the point at which the study was terminated due to lack of further eligible patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None