Covid19Phase 1NCT04801056
Study of TB006 in Outpatient Patients With Mild to Moderate COVID-19
A Phase 1 study testing TB006 in people with Covid19, run by TrueBinding, Inc..
Trial summary
TB006, a monoclonal antibody, is an anti-inflammatory and anti-fibrotic agent that reduces the severity of underlying diseases in COVID-19 patients. The primary objective of TB006 treatment is to decrease the potential acute severe deterioration in outpatient COVID-19 patients with underlying diseases, such as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- TB006
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to 1 Sep 2021
- Phase
- Phase 1
- 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
- Willing and able to provide written informed consent prior to performing study procedures (or legally authorized representative able to provide consent on the patient's behalf).
- Age ≥ 18 years
- A positive Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR) test or an equivalent test ≤ 3 days before randomization
- Patients with mild to moderate COVID-19 experiencing any of the following symptoms:
- Mild (without shortness of breath or dyspnea): Fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms
- Moderate: Any symptom of mild illness, shortness of breath with excursion, clinically suggestive of moderate illness with COVID-19, such as respiratory rate ≥ 20 breaths per minute, saturation of oxygen (SpO2) > 93% on room air at sea level, heart rate ≥ 90 beats per minute
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- At low risk for progressing to severe COVID-19 and/or hospitalization.
- Adequate organ function at screening as evidenced by:
- Hemoglobin > 10.9 g/dL
- Absolute neutrophil count (ANC) > 1.0 × 10^9/L
- Platelets > 125 × 10^9/L
- Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) < 1.25 × upper limit of normal (ULN)
- Creatinine clearance > 90 mL/min using the Cockcroft-Gault formula for patients ≥ 18 years of age [Cockcroft 1976]
- Normal electrocardiogram with QTcF of ≤ 450 ms
Who cannot join
- Participation in any other clinical trial of an experimental treatment for COVID-19
- Clinical signs indicative of Severe or Critical Illness Severity
- SEVERE:
- Any symptom of severe, systematic illness, including moderate illness, shortness of breath, or respiratory distress
- Clinically suggestive of severe illness with COVID-19, such as respiratory rate ≥ 30 breaths per minute, heart rate ≥ 125 per minute, saturation of oxygen (SpO2) ≤ 93% on room air at sea level, or PaO2/FiO2 < 300
- CRITICAL ILLNESS (one of the following):
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- Respiratory failure defined based on resource utilization requiring at least one of the following:
- Endotracheal intubation and mechanical ventilation, oxygen delivered by high483 flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates > 20 L/min with fraction of delivered oxygen ≥ 0.5)
- Noninvasive positive pressure ventilation, ECMO, or clinical diagnosis of respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation)
- Shock (defined by systolic blood pressure < 90 mm Hg, or diastolic blood pressure < 60 mm Hg or requiring vasopressors)
- Multi-organ dysfunction/failure
- Have a history of a positive SARS-CoV-2 serology test
- Evidence of shock (defined by systolic blood pressure < 90 mm Hg, or diastolic blood pressure < 60 mm Hg or requiring vasopressors)
- Patients who are hospitalized due to COVID-19
- Patients who required oxygen therapy due to COVID-19
- Patients who required mechanical ventilation or anticipated impending need for mechanical ventilation
- Receiving V-V ECMO ≥ 5 days, or any duration of V-A ECMO
- Have a history of convalescent COVID-19 plasma treatment
- Women who are pregnant or breastfeeding
- Male or female of childbearing potential who has plans to become pregnant during the study period and for six months after the clinical study or who is not willing to take appropriate contraceptive measures (e.g., concomitant use of a spermicidal agent, barrier contraceptive, or/and intrauterine contraceptive)
- Viral disease (HIV, HBV, HCV, etc.) other than COVID-19 that are not adequately controlled or require administration of other antiviral agents or medications that could potentially interact with TB006
- Patients with a history or current evidence of any concomitant condition, therapy, or laboratory abnormality that, in the opinion of the investigator, might confound the results of the trial, interfere with the patient's participation and compliance
About this study
Official title: A Phase I, First-In-Human, Randomized, Single Ascending Dose Study of TB006 in Outpatient Patients With Mild to Moderate COVID-19
TB006, a monoclonal antibody, is an anti-inflammatory and anti-fibrotic agent that reduces the severity of underlying diseases in COVID-19 patients. The primary objective of TB006 treatment is to decrease the potential acute severe deterioration in outpatient COVID-19 patients with underlying diseases, such as diabetes, hypertension, and cancer. TB006 has been developed to treat the ambulatory patients with diagnosed mild to moderate COVID-19 who are considered at low risk for severe disease or hospitalization.
Read the detailed description
TB006, a monoclonal antibody, is an anti-inflammatory and anti-fibrotic agent that reduces the severity of underlying diseases in COVID-19 patients. The primary objective of TB006 treatment is to decrease the potential acute severe deterioration in outpatient COVID-19 patients with underlying diseases, such as diabetes, hypertension, and cancer. TB006 has been developed to treat the ambulatory patients with diagnosed mild to moderate COVID-19 who are considered at low risk for severe disease or hospitalization.
In the single ascending dose study, the dosages of 5 mg/kg ~ 50 mg/kg will be investigated in patients with mild to moderate COVID-19, and will be administered to patients over 60 minutes after dilution in 0.9% Sodium Chloride Injection, USP (normal saline) to a final volume of 250 mL. The primary objective of the SAD study is to evaluate the safety and tolerability of single ascending doses of TB006 vs placebo administered via i.v. infusion in outpatient patients with mild-to-moderate COVID-19 and to determine the dose recommended for Phase Ib study.
- Conditions
- Covid19
- Being tested
- TB006, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TB006Drug
TB006 monoclonal antibody
PlaceboOther
Placebo i.v. infusion
| Study group | Role | What they receive |
|---|---|---|
| TB006 | Experimental | During the SAD study, subjects will receive a single dose of TB006 (at the dosage level of 10 ~ 50 mg/kg) administered via i.v. infusion for 60 mins.
In addition, a sentinel cohort of 5 mg/kg will be open for enrollment and double-blinded randomization first, with 2 patients randomized to active/TB006 arm, to assess preliminary safety and tolerability of study drug, and to determine cohort expansion and dose escalation. Upon the completion of sentinel cohort and all subjects are safe and well tolerate study treatment, regular dose escalation will start. Receives: Drug: TB006 |
| Placebo | Placebo comparator | During the SAD study, subjects will receive a single dose of the placebo administered via i.v. infusion for 60 mins.
In addition, the corresponding sentinel placebo group will include 1 patient to placebo arm. Upon the completion of sentinel cohort and all subjects are safe and well tolerate study treatment, regular dose escalation will start. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment emergent adverse events
Evaluated as per DAIDS v2.1
Measured: Baseline to Day 85
Secondary outcomes (13)
Pharmacokinetic parameters of TB006: AUC(0-last)
- Area under the plasma concentration curve over time (hr*µg/mL)
Measured: Day 1 to Day 85
Pharmacokinetic parameters of TB006: Cmax
- Maximum concentration of TB006 (µg/mL)
Measured: Day 1 to Day 85
Pharmacokinetic parameters of TB006: Tmax
- The amount of time that TB006 is present at the maximum concentration (hours)
Measured: Day 1 to Day 85
Pharmacokinetic parameters of TB006: T1/2
- Half life of TB006 (hours)
Measured: Day 1 to Day 85
Immunogenicity
- Anti-drug antibodies (ADA)
Measured: Day 1 to Day 85
Preliminary Efficacy: Viral shedding change
Change from baseline in viral shedding from Day 1 to Day 28, as measured by RT-qPCR
Measured: Day 1 to Day 28
Preliminary Efficacy: Viral shedding change at each visit
Change from baseline in viral shedding at each visit through Day 28, as measured by RT-qPCR
Measured: Baseline to Day 28
Preliminary Efficacy: Time to viral shedding clearance
Measure the time to viral shedding clearance
Measured: Baseline to Day 85
Preliminary Efficacy: Proportion of treated patients with ≥ 1 COVID-19 related medically-attended visit through Day 28
Proportion of treated patients with ≥ 1 COVID-19 related medically-attended visit through Day 28
Measured: Baseline to Day 28
Preliminary Efficacy: Total number of COVID-19 related medically-attended visits
Number of COVID-19 related medically-attended visits during study
Measured: Baseline to Day 28
Preliminary Efficacy: Proportion of treated patients admitted to a hospital due to COVID-19
Proportion of patients admitted to a hospital by Day 28
Measured: Baseline to Day 28
Preliminary Efficacy: Time to sustained clinical recovery from baseline
Time to sustained clinical recovery from baseline to end of follow-up visits
Measured: Baseline to Day 85
Preliminary Efficacy: Clinical improvement from baseline at each visit through Day 28 (in patients with or without underlying comorbidities
Measured by change in score according to the World Health Organization (WHO) ordinal scale, ranging from 0 (uninfected) to 8 (dead)
Measured: Baseline to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start1 Jun 2021
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Why it stopped: Difficulty in patient recruitment and will start again if study population increases to allow study feasibility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single Ascending Dose
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- TrueBinding, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801056
- Sponsor's protocol ID
- TB006C1101
- Status last verified
- May 2022
- First submitted
- 11 Mar 2021
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, First-In-Human, Randomized, Single Ascending Dose Study of TB006 in Outpatient Patients With Mild to Moderate COVID-19
- ClinicalTrials.gov ID
- NCT04801056
- Acronym / sponsor ID
- TB006C1101
- Conditions
- Covid19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty in patient recruitment and will start again if study population increases to allow study feasibility
- Enrolment
- 0 participants (actual)
- Lead sponsor
- TrueBinding, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 16 Mar 2021 (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.
TB006, a monoclonal antibody, is an anti-inflammatory and anti-fibrotic agent that reduces the severity of underlying diseases in COVID-19 patients. The primary objective of TB006 treatment is to decrease the potential acute severe deterioration in outpatient COVID-19 patients with underlying diseases, such as diabetes, hypertension, and cancer. TB006 has been developed to treat the ambulatory patients with diagnosed mild to moderate COVID-19 who are considered at low risk for severe disease or hospitalization.
Detailed description
TB006, a monoclonal antibody, is an anti-inflammatory and anti-fibrotic agent that reduces the severity of underlying diseases in COVID-19 patients. The primary objective of TB006 treatment is to decrease the potential acute severe deterioration in outpatient COVID-19 patients with underlying diseases, such as diabetes, hypertension, and cancer. TB006 has been developed to treat the ambulatory patients with diagnosed mild to moderate COVID-19 who are considered at low risk for severe disease or hospitalization.
In the single ascending dose study, the dosages of 5 mg/kg ~ 50 mg/kg will be investigated in patients with mild to moderate COVID-19, and will be administered to patients over 60 minutes after dilution in 0.9% Sodium Chloride Injection, USP (normal saline) to a final volume of 250 mL. The primary objective of the SAD study is to evaluate the safety and tolerability of single ascending doses of TB006 vs placebo administered via i.v. infusion in outpatient patients with mild-to-moderate COVID-19 and to determine the dose recommended for Phase Ib study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Single Ascending Dose
| Arm | Type | Receives |
|---|---|---|
| TB006 | Experimental | Drug: TB006During the SAD study, subjects will receive a single dose of TB006 (at the dosage level of 10 ~ 50 mg/kg) administered via i.v. infusion for 60 mins. In addition, a sentinel cohort of 5 mg/kg will be open for enrollment and double-blinded randomization first, with 2 patients randomized to active/TB006 arm, to assess preliminary safety and tolerability of study drug, and to determine cohort expansion and dose escalation. Upon the completion of sentinel cohort and all subjects are safe and well tolerate study treatment, regular dose escalation will start. |
| Placebo | Placebo comparator | Other: PlaceboDuring the SAD study, subjects will receive a single dose of the placebo administered via i.v. infusion for 60 mins. In addition, the corresponding sentinel placebo group will include 1 patient to placebo arm. Upon the completion of sentinel cohort and all subjects are safe and well tolerate study treatment, regular dose escalation will start. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Willing and able to provide written informed consent prior to performing study procedures (or legally authorized representative able to provide consent on the patient's behalf).
- Age ≥ 18 years
- A positive Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR) test or an equivalent test ≤ 3 days before randomization
- Patients with mild to moderate COVID-19 experiencing any of the following symptoms:
- At low risk for progressing to severe COVID-19 and/or hospitalization.
Key exclusion criteria (22 listed)
- Participation in any other clinical trial of an experimental treatment for COVID-19
- Clinical signs indicative of Severe or Critical Illness Severity
- Have a history of a positive SARS-CoV-2 serology test
- Evidence of shock (defined by systolic blood pressure < 90 mm Hg, or diastolic blood pressure < 60 mm Hg or requiring vasopressors)
- Patients who are hospitalized due to COVID-19
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 |
|---|---|---|
| TB006TB006 monoclonal antibody | Drug | TB006 |
| PlaceboPlacebo i.v. infusion | Other | Placebo |
Primary outcome
Treatment emergent adverse events
Time frame: Baseline to Day 85
Evaluated as per DAIDS v2.1
13 secondary outcomes
Pharmacokinetic parameters of TB006: AUC(0-last)
Time frame: Day 1 to Day 85
Pharmacokinetic parameters of TB006: Cmax
Time frame: Day 1 to Day 85
Pharmacokinetic parameters of TB006: Tmax
Time frame: Day 1 to Day 85
Pharmacokinetic parameters of TB006: T1/2
Time frame: Day 1 to Day 85
Immunogenicity
Time frame: Day 1 to Day 85
Preliminary Efficacy: Viral shedding change
Time frame: Day 1 to Day 28
Preliminary Efficacy: Viral shedding change at each visit
Time frame: Baseline to Day 28
Preliminary Efficacy: Time to viral shedding clearance
Time frame: Baseline to Day 85
Preliminary Efficacy: Proportion of treated patients with ≥ 1 COVID-19 related medically-attended visit through Day 28
Time frame: Baseline to Day 28
Preliminary Efficacy: Total number of COVID-19 related medically-attended visits
Time frame: Baseline to Day 28
Preliminary Efficacy: Proportion of treated patients admitted to a hospital due to COVID-19
Time frame: Baseline to Day 28
Preliminary Efficacy: Time to sustained clinical recovery from baseline
Time frame: Baseline to Day 85
Preliminary Efficacy: Clinical improvement from baseline at each visit through Day 28 (in patients with or without underlying comorbidities
Time frame: Baseline to Day 28
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TB006 in people with Covid19, run by TrueBinding, Inc..
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 14 inclusion and 22 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: withdrawn, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment emergent adverse events (time frame: Baseline to Day 85). 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 18 May 2022.