This study is a double-blind,randomized,placebo-controlled study to evaluate the efficacyand safety of FB2001 for Inhalation in patients with mild to moderate Coronavirus Disease2019(COVID-19). A total of about 1336 subjects are planned to be enrolled. The subjectswill be randomized in a 1:1 ratio to FB2001 group or placebo group while both receivingstandard of care treatment.
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.
Drug: FB2001
FB2001 for Inhalation will be reconstituted with normal saline prior to nebulized
inhalation. FB2001 will be administered by nebulized inhalation.
Other Name: FB2001 for Inhalation
Drug: FB2001 placebo
FB2001 placebo will be reconstituted with normal saline prior to nebulized inhalation.
FB2001 placebo will be administered by nebulized inhalation.
Other Name: placebo
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.
Shenzhen Third People's Hospital
Shenzhen, Guangdong, China
Investigator: Dan Shu
Investigator: Hongzhou Lu
Yue Zhang
+86 02569760330
lczhangyue@frontierbiotech.com
Cheng Yao
yaocheng@frontierbiotech.com
Cheng Yao, Study Director
Frontier Biotechnologies Inc.