COVID-19Phase 2/3NCT05445934
Evaluate the Efficacy and Safety of FB2001 in Hospitalized Patients With Moderate to Severe COVID-19 (BRIGHT Study)
A Phase 2/3 study testing FB2001 in people with COVID-19, run by Frontier Biotechnologies Inc. at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- FB2001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,188 participants
- Where
- 2 sitesChina
- Study dates
- 14 Sep 2022to Dec 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
Cheng Yao contact
China2 sites, 2 recruiting
- Recruiting
Beijing Ditan Hospital Capital Medical University
Beijing
Cuiyun Wu
Ronghua Jin
- Recruiting
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality
Yunao Zhou
Wenhong Zhang
About this study
Official title: A Phase II/III, Double-Blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of FB2001 in Hospitalized Patients With Moderate to Severe COVID-19
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.
Read the 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 two phase I clinical trials, we completed doses of FB2001 that were safe, 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 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
- Being tested
- FB2001, FB2001 placebo
- Keywords
- severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FB2001Drug
Also called DC402234
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.
FB2001 placeboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| FB2001 group | Experimental | FB2001 will be administered by IV infusion twice daily (BID) for up to 5 days, plus SOC. Receives: Drug: FB2001 |
| Placebo group | Placebo comparator | Placebo will be administered by IV infusion twice daily (BID) for up to 5 days, plus SOC. Receives: Drug: FB2001 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to Day 29
Secondary outcomes (12)
Proportion of participants with mechanical ventilation or all-cause-death
Proportion of participants with mechanical ventilation or all-cause-death in FB2001 group and placebo group
Measured: Through Day 29 and Day 60
Proportion of participants with sustained recovery on Day 6
no specific description
Measured: On Day 6
Clinical status category as assessed by an 8-category ordinal scale daily while hospitalized and on Days, 15 and 29.
no specific description
Measured: On Days 15 and 29
Duration of each targeted COVID-19 sign/symptom until discharge
Duration of each targeted COVID-19 sign/symptom until discharge
Measured: Up to Day 29
Severity of each targeted COVID-19 sign/symptom until discharge
no specific description
Measured: Up to Day 29
Days of supplemental oxygen (if applicable)
no specific description
Measured: Up to Day 29
Duration of non-invasive ventilation/high-flow oxygen (if applicable)
no specific description
Measured: Up to Day 29
Days of invasive mechanical ventilation/ECMO (if applicable)
no specific description
Measured: Up to Day 29
Time to achieve SARS-CoV-2 virologic clearance
no specific description
Measured: Up to Day 29
Proportion of participants achieving SARS-CoV-2 virologic clearance on Day 3, 5, 8, 15 and 29
no specific description
Measured: On Day 3, 5, 8, 15 and 29
Viral load change (log10) from baseline on Day 3, 5, 8 and 15.
no specific description
Measured: On Day 3, 5, 8 and 15
Population pharmacokinetic (PK) parameters to be measured/analyzed, including AUC, Cmax and Ctrough
no specific descriptionsa
Measured: Day0-Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start14 Sep 2022
- Primary completionNov 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Frontier Biotechnologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cheng Yao, Study director, Frontier Biotechnologies Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05445934
- Sponsor's protocol ID
- FB2001-301
- Status last verified
- Jan 2023
- First submitted
- 27 Jun 2022
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 36354082
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III, Double-Blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of FB2001 in Hospitalized Patients With Moderate to Severe COVID-19
- ClinicalTrials.gov ID
- NCT05445934
- Acronym / sponsor ID
- FB2001-301
- Conditions
- COVID-19
- Keywords
- severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,188 participants (estimated)
- Lead sponsor
- Frontier Biotechnologies Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 6 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 two phase I clinical trials, we completed doses of FB2001 that were safe, 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FB2001 group | Experimental | Drug: FB2001FB2001 will be administered by IV infusion twice daily (BID) for up to 5 days, plus SOC. |
| Placebo group | Placebo comparator | Drug: FB2001 placeboPlacebo will be administered by IV infusion twice daily (BID) for up to 5 days, plus SOC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ≥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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FB2001Also: DC402234FB2001 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. | Drug | FB2001 group |
| FB2001 placeboPlacebo will be reconstituted with 100 mL of normal saline prior to intravenous infusion. Placebo will be administered by IV infusion over approximately 60 minutes. | Drug | Placebo group |
Primary outcome
Time to sustained recovery (in days) from randomization up to Day 29.
Time frame: 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
12 secondary outcomes
Proportion of participants with mechanical ventilation or all-cause-death
Time frame: Through Day 29 and Day 60
Proportion of participants with sustained recovery on Day 6
Time frame: On Day 6
Clinical status category as assessed by an 8-category ordinal scale daily while hospitalized and on Days, 15 and 29.
Time frame: On Days 15 and 29
Duration of each targeted COVID-19 sign/symptom until discharge
Time frame: Up to Day 29
Severity of each targeted COVID-19 sign/symptom until discharge
Time frame: Up to Day 29
Days of supplemental oxygen (if applicable)
Time frame: Up to Day 29
Duration of non-invasive ventilation/high-flow oxygen (if applicable)
Time frame: Up to Day 29
Days of invasive mechanical ventilation/ECMO (if applicable)
Time frame: Up to Day 29
Time to achieve SARS-CoV-2 virologic clearance
Time frame: Up to Day 29
Proportion of participants achieving SARS-CoV-2 virologic clearance on Day 3, 5, 8, 15 and 29
Time frame: On Day 3, 5, 8, 15 and 29
Viral load change (log10) from baseline on Day 3, 5, 8 and 15.
Time frame: On Day 3, 5, 8 and 15
Population pharmacokinetic (PK) parameters to be measured/analyzed, including AUC, Cmax and Ctrough
Time frame: Day0-Day 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Derived from this study: PubMed 36354082Shang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheng Yao contact
Cheng Yao study director
Frontier Biotechnologies Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing FB2001 in people with COVID-19, run by Frontier Biotechnologies Inc. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chengchen Sun (+86 02569760330, ccsun@frontierbiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to sustained recovery (in days) from randomization up to Day 29. (time frame: Up to Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05445934, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2023.