Mild to Moderate COVID-19Phase 2/3NCT05675072
Evaluate the Efficacy and Safety of FB2001 for Inhalation in Patients With Mild to Moderate COVID-19
A Phase 2/3 study testing FB2001 in people with Mild to Moderate COVID-19, run by Frontier Biotechnologies Inc. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild to Moderate COVID-19
- What is being tested?
- FB2001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,336 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2023to 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
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Cheng Yao contact
China1 site, 1 recruiting
- Recruiting
Shenzhen Third People's Hospital
Shenzhen, Guangdong
Dan Shu
Hongzhou Lu
About this study
Official title: 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
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.
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 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.
- Conditions
- Mild to Moderate COVID-19
- Being tested
- FB2001, FB2001 placebo
- Keywords
- severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), FB2001, Coronavirus
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FB2001Drug
Also called FB2001 for Inhalation
FB2001 for Inhalation will be reconstituted with normal saline prior to nebulized inhalation. FB2001 will be administered by nebulized inhalation.
FB2001 placeboDrug
Also called placebo
FB2001 placebo will be reconstituted with normal saline prior to nebulized inhalation. FB2001 placebo will be administered by nebulized inhalation.
| Study group | Role | What they receive |
|---|---|---|
| FB2001 group | Experimental | FB2001 will be administered by nebulized inhalation, plus Standard Of Care(SOC) Receives: Drug: FB2001 |
| Placebo group | Placebo comparator | Placebo will be administered by nebulized inhalation, plus Standard Of Care(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 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.
Measured: Up to Day 29
Secondary outcomes (10)
Proportion of participants who have progression of COVID-19 .
Disease progression is defined as disease severity from mild to moderate or severe or critical, or moderate to severe or critical, or all-cause death
Measured: Up to Day 29
Time to sustained alleviation of COVID-19-related sign/symptom.
Sustained alleviation of COVID-19-related signs/symptoms are defined as the COVID-19-related sign/symptom score from 0 or 1 to 0 at baseline or from 2 or 3 to 1 or 0 at baseline for 3 consecutive days.
Measured: Up to Day 29
Time to sustained recovery of 5 key COVID-19-related sign/symptom
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.
Measured: Up to Day 29
Time to sustained alleviation of 5 key COVID-19-related sign/symptom
Sustained alleviation of COVID-19-related signs/symptoms are defined as the COVID-19-related sign/symptom score from 0 or 1 to 0 at baseline or from 2 or 3 to 1 or 0 at baseline for 3 consecutive days.
Measured: Up to Day 29
Proportion of participants who experience sustained recovery of COVID-19 sign/symptom
no special description
Measured: Day 3 to Day 21
Proportion of participants who experience sustained alleviation of COVID-19-related sign/symptom
no special description
Measured: Day 3 to Day 21
Duration of each targeted COVID-19-related sign/symptom.
no special description
Measured: Up to Day 29
Time to sustained virus clearance of SARS-CoV-2 in nasopharyngeal swabs
no special description
Measured: Up to Day 29
Changes in SARS-CoV-2 viral load
no special description
Measured: Up to Day 29
Change in EQ-5D-5L index score
The Euroquol Quality of Life 5-Dimension 5-Level Scale(EQ-5D-5L) index score consists of five dimensions: mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. Each dimension has five scales: no difficulty, a little difficulty, moderate difficulty, severe difficulty, and very severe difficulty
Measured: Up to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start4 Jan 2023
- Primary completionSep 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate 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
- 1,336 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
- NCT05675072
- Sponsor's protocol ID
- FB2001-302
- Status last verified
- Jan 2023
- First submitted
- 2 Jan 2023
- Last updated
- 9 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05675072
- Acronym / sponsor ID
- FB2001-302
- Conditions
- Mild to Moderate COVID-19
- Keywords
- severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), FB2001, Coronavirus
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,336 participants (estimated)
- Lead sponsor
- Frontier Biotechnologies Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Jan 2023 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 9 Jan 2023 (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 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.
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 nebulized inhalation, plus Standard Of Care(SOC) |
| Placebo group | Placebo comparator | Drug: FB2001 placeboPlacebo will be administered by nebulized inhalation, plus Standard Of Care(SOC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (15 listed)
- 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)
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: FB2001 for InhalationFB2001 for Inhalation will be reconstituted with normal saline prior to nebulized inhalation. FB2001 will be administered by nebulized inhalation. | Drug | FB2001 group |
| FB2001 placeboAlso: placeboFB2001 placebo will be reconstituted with normal saline prior to nebulized inhalation. FB2001 placebo will be administered by nebulized inhalation. | Drug | Placebo group |
Primary outcome
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.
10 secondary outcomes
Proportion of participants who have progression of COVID-19 .
Time frame: Up to Day 29
Time to sustained alleviation of COVID-19-related sign/symptom.
Time frame: Up to Day 29
Time to sustained recovery of 5 key COVID-19-related sign/symptom
Time frame: Up to Day 29
Time to sustained alleviation of 5 key COVID-19-related sign/symptom
Time frame: Up to Day 29
Proportion of participants who experience sustained recovery of COVID-19 sign/symptom
Time frame: Day 3 to Day 21
Proportion of participants who experience sustained alleviation of COVID-19-related sign/symptom
Time frame: Day 3 to Day 21
Duration of each targeted COVID-19-related sign/symptom.
Time frame: Up to Day 29
Time to sustained virus clearance of SARS-CoV-2 in nasopharyngeal swabs
Time frame: Up to Day 29
Changes in SARS-CoV-2 viral load
Time frame: Up to Day 29
Change in EQ-5D-5L index score
Time frame: Up to Day 29
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
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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.
1 site 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 Mild to Moderate COVID-19, run by Frontier Biotechnologies Inc. at 1 site 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 7 inclusion and 15 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 9 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 1 site 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 Yue Zhang (+86 02569760330, lczhangyue@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 of COVID-19-related signs/symptoms (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?
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 9 Jan 2023.