Evaluate the Efficacy and Safety of FB2001 in Hospitalized Patients With Moderate to Severe COVID-19 (BRIGHT Study)

NCT05445934 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: FB2001-301
• Study Type: interventional
• Target: 1,188
• Locations: 1 country
• Sites: 2

Brief Summary

This study is a double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of FB2001 in hospitalized patients with moderate to severe Coronavirus Disease 2019 (COVID-19). A total of about 1188 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

COVID-19

Keywords

severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)

Outcome Measures

Primary Outcomes (1)

• Time to sustained recovery (in days) from randomization up to Day 29.

  Day of sustained recovery is defined as the first day on which a subject is discharged from hospital, or hospitalized for infection-control or other non-medical reasons through Day 29

  Up to Day 29

Secondary Outcomes (12)

• Proportion of participants with mechanical ventilation or all-cause-death

  Through Day 29 and Day 60

• Proportion of participants with sustained recovery on Day 6

  On Day 6

• Clinical status category as assessed by an 8-category ordinal scale daily while hospitalized and on Days, 15 and 29.

  On Days 15 and 29

• Duration of each targeted COVID-19 sign/symptom until discharge

  Up to Day 29

• Severity of each targeted COVID-19 sign/symptom until discharge

  Up to Day 29

Other Outcomes (9)

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

  Up to Day 60

• Incidence of withdrawals due to Adverse Events (AEs)

  Up to Day 60

• Incidence of Treatment-Related Adverse Events (TRAEs)

  Up to Day 60

Study Arms (2)

FB2001 group

EXPERIMENTAL

FB2001 will be administered by IV infusion twice daily (BID) for up to 5 days, plus SOC.

Drug: FB2001

Placebo group

PLACEBO COMPARATOR

Placebo will be administered by IV infusion twice daily (BID) for up to 5 days, plus SOC.

Drug: FB2001 placebo

Interventions

FB2001 DRUG

FB2001 for injection will be reconstituted with 100 mL of normal saline prior to intravenous infusion. FB2001 will be administered by IV infusion over approximately 60 minutes.

Also known as: DC402234

FB2001 group

FB2001 placebo DRUG

Placebo will be reconstituted with 100 mL of normal saline prior to intravenous infusion. Placebo will be administered by IV infusion over approximately 60 minutes.

Placebo group

Eligibility Criteria

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

You may qualify if:

• ≥18 years old, male or female.
• Subjects hospitalized with moderate to severe COVID-19 with a category 4 or 5 on an 8-category ordinal scale.
• Has laboratory-confirmed COVID-19 infection within 5 days prior to randomization.
• Initial COVID-19 symptom onset within 5 days prior to randomization and ≥1 sign/symptom attributable to COVID-19 within 24 hours before randomization.
• The underlying medical condition was well controlled prior to SARS CoV 2 infection and does not affect daily life.
• Subject who did not receive COVID 19 (primary series or booster) vaccine within the 6 months prior to screening.
• The subject is willing to provide written informed consent to participate in the study after reading the informed consent form and the information provided and has had the opportunity to discuss the study with the Investigator or designee.
• The subject is able to communicate satisfactorily with the Investigator and to participate in, and comply with, the requirements of the study.
• The subject is able to understand the nature of the study and any potential hazards associated with participating in it.
• Negative pregnancy test for female subjects of childbearing potential and female subjects less than 2 years of postmenopause. Women of childbearing potential (WOCBP) and Women of non-childbearing potential are eligible to participate. Both women of childbearing potential and women of non-childbearing potential must use an approved method of birth control and agrees to continue to use this method for the duration of the study and for 30 days after taking the last dose of FB2001.

You may not qualify if:

• Pregnant or breastfeeding, or intending to become pregnant during the study or within 30 days after the final dose or who are not willing to use a highly effective method of contraception.
• HIV-infected subjects with viral load greater than 400 copies/mL or CD4 count less than 200 cell/µL from known medical history within past 6 months of the Screening Visit.
• Subject with moderate to severe hepatic impairment or acute liver failure.
• Known severe kidney disease.
• Participated in other intervention studies within 6 months.
• Has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments including but not limited to participants who are not expected to survive longer than 48 hours after randomization, or participants who are expected to require mechanical ventilation within 48 hours after randomization, or participants with a recent history of mechanical ventilation.
• Subjects receiving any medications or substances that are strong inhibitors or inducers of CYP3A within 14 days of randomization.
• Received, ongoing or planed treatment with other anti-SARS CoV 2 therapeutics (including but not limited to known anti-SARS CoV 2 antibodies, small molecule antivirals, etc., other than remdesivir).
• Other conditions that may increase the risk of study participation or, in the Investigator's judgment, make the participant inappropriate for the study.
• Have known hypersensitivity to FB2001 or its excipients.
• Any planned vaccine within 28 days following the last administration of FB2001 for Injection.

Sponsors & Collaborators

• Frontier Biotechnologies Inc.: lead

Study Sites (2)

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

Beijing Ditan Hospital Capital Medical University

Beijing, China

RECRUITING

Related Publications (1)

• Shang W, Dai W, Yao C, Xu L, Tao X, Su H, Li J, Xie X, Xu Y, Hu M, Xie D, Jiang H, Zhang L, Liu H. In vitro and in vivo evaluation of the main protease inhibitor FB2001 against SARS-CoV-2. Antiviral Res. 2022 Dec;208:105450. doi: 10.1016/j.antiviral.2022.105450. Epub 2022 Oct 29.

  PMID: 36354082 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

FB2001

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Cheng Yao

  Frontier Biotechnologies Inc.

  STUDY DIRECTOR

Central Study Contacts

Chengchen Sun

CONTACT

+86 02569760330; ccsun@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: June 27, 2022
• First Posted: July 6, 2022
• Study Start: September 14, 2022
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 5, 2023

Record last verified: 2023-01

Locations

CN (2)