A Phase 2/3 Study to Evaluate FP-025 in Patients With Severe to Critical COVID 19

NCT04750278 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: FP02C-20-001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 8

Brief Summary

This is a Phase 2/3, 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.

Conditions

Severe to Critical COVID 19 With Associated ARDS

Outcome Measures

Primary Outcomes (1)

• The Percentage of Patients Alive and Not Requiring Non-invasive or Invasive Ventilation

  Percentage of patients alive and not requiring non-invasive or invasive ventilation at Day 28

  Day 28

Secondary Outcomes (5)

• Percentage of Patients on Invasive Mechanical Ventilation

  Day 28

• Percentage of Patients Alive

  Day 28

• Percentage of Patients Alive and Not Requiring Non-invasive or Invasive Ventilation

  Day 60

• Percentage of Patients on Invasive Mechanical Ventilation

  Day 60

• Percentage of Patients Alive

  Day 60

Other Outcomes (15)

• Quantitative Assessment of Lung Fibrosis

  Day 28 and Day 60

• Percentage of Patients Who Were Randomized on Invasive Mechanical Ventilation Who Are Free of Invasive Mechanical Ventilation

  Day 28 and at Day 60

• Number of Ventilator Free Days (ie, Days Free of Invasive Mechanical Ventilation)

  Day 28 and Day 60

Study Arms (3)

FP-025 100 mg

EXPERIMENTAL

Low dose for patient treatment.

Drug: FP-025 100 mg

FP-025 300 mg

EXPERIMENTAL

High dose for patient treatment.

Drug: FP-025 300 mg

Placebo

PLACEBO COMPARATOR

Dose without any study drug, to make it a controlled study.

Drug: Placebo

Interventions

FP-025 100 mg DRUG

FP-025 100 mg BID

Also known as: Active

FP-025 100 mg

FP-025 300 mg DRUG

FP-025 300 mg BID

Also known as: Active

FP-025 300 mg

Placebo DRUG

Placebo BID

Also known as: Non-Active

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is willing to provide informed consent (or has a legally authorized representative \[LAR\] willing to provide informed consent) and is willing and able (or has an LAR willing and able) to comply with the protocol required therapy, monitoring, and follow-up;
• Is a male or female aged ≥ 18 years;
• Has a COVID-19 diagnosis confirmed by a documented, positive severe acute respiratory syndrome (SARS) CoV-2 reverse transcriptase polymerase chain reaction test (or equivalent test) immediately prior to or during the current hospitalization;
• Is hospitalized with severe to critical COVID 19 within a 72-hour period prior to the Screening Visit and meeting the following characteristics:
• Diagnosed with ARDS based on the Berlin criteria as follows:
• Respiratory symptoms developed within 1 week of a known clinical insult or new or worsening respiratory symptoms developed during the past week;
• Chest radiograph or computed tomography scan shows bilateral opacities not fully explained by pleural effusions, lobar or lung collapse, or pulmonary nodules; and
• Respiratory failure is not fully explained by cardiac failure or fluid overload; and
• Requiring at least 1 of the following:
• Endotracheal intubation and mechanical ventilation;
• Oxygen delivered by high flow nasal cannula (heated, humidified oxygen delivered via reinforced nasal cannula at flow rates \> 20 L/minute with a fraction of delivered oxygen ≥ 0.5);
• Non invasive positive pressure ventilation; or
• Clinical diagnosis of respiratory failure (ie, the clinical need for 1 of the preceding therapies, but preceding therapies are unable to be administered in the setting of resource limitations);
• If female, is post-menopausal for at least 1 year, surgically sterile (documented by medical record), or a woman of childbearing potential (WCBP) who agrees to use a highly effective method of birth control (ie, method with a failure rate \< 1% per year) from enrollment until 30 days following the last dose of study drug. Highly effective methods of birth control are defined as follows: complete sexual abstinence, intrauterine device, intrauterine hormone-releasing system, progestogen-only hormonal contraception (implant, injectable, or oral), and combined (estrogen and progestogen) contraception (oral, intravaginal, or transdermal);
• If a WCBP, must have a negative serum human chorionic gonadotropin pregnancy test at the Screening Visit, and must agree to monthly urine pregnancy tests during the study; and

You may not qualify if:

• Is not expected to survive more than 24 hours;
• Is on extracorporeal membrane oxygenation (ECMO) at the Screening Visit;
• Has an underlying clinical condition where, in the opinion of the Investigator, it would be extremely unlikely that the patient would come off ventilation (eg, motor neuron disease, Duchenne muscular dystrophy, or rapidly progressive pulmonary fibrosis);
• Has a known history of idiopathic pulmonary fibrosis or interstitial lung disease as defined by the American Thoracic Society 2018 guidelines;
• Has known active tuberculosis (TB), a history of incompletely treated TB, and/or suspected or known extrapulmonary TB;
• Has Child Pugh Class B or C active liver disease or an alanine aminotransferase or aspartate aminotransferase level \> 4 x the upper limit of normal at the Screening Visit;
• Has moderate to severe renal insufficiency, defined as an estimated glomerular filtration rate (eGFR) ≤ 30 mL/min/1.73 m2, at the Screening Visit or requires hemodialysis;
• Has a malignant tumor (excluding a malignant tumor cured with no recurrence in the past 5 years, completely resected basal cell and squamous cell carcinoma of skin, and/or completely resected carcinoma in situ of any type);
• Has an uncontrolled systemic or local autoimmune or inflammatory disease besides COVID 19;
• Has evidence of an active concurrent non COVID 19 pneumonia (requiring additional antimicrobial treatment) caused by a known or suspected bacterial pathogen, respiratory syncytial virus (RSV), influenza virus, SARS CoV 1, Middle East respiratory syndrome CoV, aspergillus, mucormycosis causing fungi, or other pulmonary pathogen(s);
• Note: A viral respiratory panel will be administered at the Screening Visit to determine eligibility. At a minimum, the panel will evaluate for RSV, influenza A, and influenza B.
• Has received any other investigational therapeutic products within 4 weeks or 5 half-lives, whichever is longer, prior to randomization;
• Has a known history of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection;
• Has a known serious allergic reaction or hypersensitivity to any components of FP-025;
• Is pregnant or breastfeeding;

Sponsors & Collaborators

• Foresee Pharmaceuticals Co., Ltd.: lead

Study Sites (8)

Velocity Chula Vista

Chula Vista, California, 91911, United States

Location

Velocity San Diego

La Mesa, California, 91942, United States

Location

Shady Grove Medical Center

Rockville, Maryland, 20850, United States

Location

University of Nevada, Las Vegas (UNLV) School of Medicine

Las Vegas, Nevada, 89102, United States

Location

Trinity Health Center

Minto, North Dakota, 58701, United States

Location

Legacy Health

Portland, Oregon, 97210, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

United Medical Memorial Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

FP-025; Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Foresee Pharma

yisheng.lee@foreseepharma.com

408-823-4807

Study Officials

• Susan Shelby, Ph.D.

  Sr. Vice President Clinical Development

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double Blind, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of FP-025 in Patients With Severe to Critical COVID 19 With Associated Acute Respiratory Distress Syndrome (ARDS).

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 11, 2021
• Study Start: April 6, 2021
• Primary Completion: April 18, 2022
• Study Completion: April 18, 2022
• Last Updated: January 5, 2024
• Results First Posted: January 5, 2024

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)