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
Overview
- Phase
- Phase 2
- Intervention
- FB2001
- Conditions
- Mild to Moderate COVID-19
- Sponsor
- Frontier Biotechnologies Inc.
- Enrollment
- 1336
- Locations
- 1
- Primary Endpoint
- Time to sustained recovery of COVID-19-related signs/symptoms
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
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-
- •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.
Arms & Interventions
FB2001 group
FB2001 will be administered by nebulized inhalation, plus Standard Of Care(SOC)
Intervention: FB2001
Placebo group
Placebo will be administered by nebulized inhalation, plus Standard Of Care(SOC)
Intervention: FB2001 placebo
Outcomes
Primary Outcomes
Time to sustained recovery of COVID-19-related signs/symptoms
Time Frame: Up to Day 29
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 Outcomes
- Proportion of participants who have progression of COVID-19 .(Up to Day 29)
- Time to sustained alleviation of COVID-19-related sign/symptom.(Up to Day 29)
- Time to sustained recovery of 5 key COVID-19-related sign/symptom(Up to Day 29)
- Time to sustained alleviation of 5 key COVID-19-related sign/symptom(Up to Day 29)
- Proportion of participants who experience sustained recovery of COVID-19 sign/symptom(Day 3 to Day 21)
- Proportion of participants who experience sustained alleviation of COVID-19-related sign/symptom(Day 3 to Day 21)
- Duration of each targeted COVID-19-related sign/symptom.(Up to Day 29)
- Time to sustained virus clearance of SARS-CoV-2 in nasopharyngeal swabs(Up to Day 29)
- Changes in SARS-CoV-2 viral load(Up to Day 29)
- Change in EQ-5D-5L index score(Up to Day 29)