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

NCT05675072 | Unknown Phase 2 DMC

• 1 other identifier: FB2001-302
• Study Type: interventional
• Target: 1,336
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild to Moderate COVID-19

Keywords

severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); FB2001; Coronavirus

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to Day 29

Secondary Outcomes (10)

• 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

Other Outcomes (12)

• Incidence and severity of Treatment-Emergent Adverse Events(TEAEs)

  Up to Day 29

• Incidence of withdrawals due to Adverse Events(AEs)

  Up to Day 29

• Incidence of Serious Adverse Events(SAEs)

  Up to Day 29

Study Arms (2)

FB2001 group

EXPERIMENTAL

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

Drug: FB2001

Placebo group

PLACEBO COMPARATOR

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

Drug: FB2001 placebo

Interventions

FB2001 DRUG

FB2001 for Inhalation will be reconstituted with normal saline prior to nebulized inhalation. FB2001 will be administered by nebulized inhalation.

Also known as: FB2001 for Inhalation

FB2001 group

FB2001 placebo DRUG

FB2001 placebo will be reconstituted with normal saline prior to nebulized inhalation. FB2001 placebo will be administered by nebulized inhalation.

Also known as: placebo

Placebo group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Frontier Biotechnologies Inc.: lead

Study Sites (1)

Shenzhen Third People's Hospital

Shenzhen, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Coronavirus Infections

Interventions

FB2001; Inhalation

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Cheng Yao

  Frontier Biotechnologies Inc.

  STUDY DIRECTOR

Central Study Contacts

Yue Zhang

CONTACT

+86 02569760330; lczhangyue@frontierbiotech.com

Cheng Yao

CONTACT

yaocheng@frontierbiotech.com

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

Study Record Dates

• First Submitted: January 2, 2023
• First Posted: January 9, 2023
• Study Start: January 4, 2023
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 9, 2023

Record last verified: 2023-01

Locations

CN (1)