Covid19 Clinical Trial
Official title:
A Phase I, First-In-Human, Randomized, Single Ascending Dose Study of TB006 in Outpatient Patients With Mild to Moderate COVID-19
Verified date | May 2022 |
Source | TrueBinding, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 1, 2021 |
Est. primary completion date | September 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. 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). 2. Age = 18 years 3. 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 4. 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 5. At low risk for progressing to severe COVID-19 and/or hospitalization. 6. 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] 7. Normal electrocardiogram with QTcF of = 450 ms Exclusion Criteria: 1. Participation in any other clinical trial of an experimental treatment for COVID-19 2. 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): - Respiratory failure defined based on resource utilization requiring at least one of the following: 1. 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) 2. 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 3. Have a history of a positive SARS-CoV-2 serology test 4. Evidence of shock (defined by systolic blood pressure < 90 mm Hg, or diastolic blood pressure < 60 mm Hg or requiring vasopressors) 5. Patients who are hospitalized due to COVID-19 6. Patients who required oxygen therapy due to COVID-19 7. Patients who required mechanical ventilation or anticipated impending need for mechanical ventilation 8. Receiving V-V ECMO = 5 days, or any duration of V-A ECMO 9. Have a history of convalescent COVID-19 plasma treatment 10. Women who are pregnant or breastfeeding 11. 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) 12. 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 13. 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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TrueBinding, Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Pharmacodynamics biomarkers: Troponins | Change in cardiac biomarkers (ng/mL) | Baseline to Day 28 | |
Other | Pharmacodynamics biomarkers: N-terminal pro B-type natriuretic peptide (NT-proBNP) | Change in cardiac biomarkers (pg/mL) | Baseline to Day 28 | |
Other | Pharmacodynamics biomarkers: Creatine kinase-MB (CK-MB) | Change in cardiac biomarkers (ng/mL) | Baseline to Day 28 | |
Other | Pharmacodynamics biomarkers: Change in neutrophil-lymphocyte ratio (NLR) | Monitor potential inflammation activity | Baseline to Day 28 | |
Other | Pharmacodynamics biomarkers: IL-6 | - Change in cytokine measurement (pg/mL) | Baseline to Day 28 | |
Other | Pharmacodynamics biomarkers: IL-2 | - Change in cytokine measurement (pg/mL) | Baseline to Day 28 | |
Other | Pharmacodynamics biomarkers: IL-7 | - Change in cytokine measurement (pg/mL) | Baseline to Day 28 | |
Other | Pharmacodynamics biomarkers: IL-8 | - Change in cytokine measurement (pg/mL) | Baseline to Day 28 | |
Other | Pharmacodynamics biomarkers: IL-1ß | - Change in cytokine measurement (pg/mL) | Baseline to Day 28 | |
Other | Pharmacodynamics biomarkers: IFNgamma | - Change in cytokine measurement (pg/mL) | Baseline to Day 28 | |
Other | Pharmacodynamics biomarkers: TNFa | - Change in cytokine measurement (pg/mL) | Baseline to Day 28 | |
Other | Pharmacodynamics biomarkers: IL-10 | - Change in cytokine measurement (pg/mL) | Baseline to Day 28 | |
Other | Pharmacodynamics biomarkers: MIP-1a/ß | - Change in cytokine measurement (pg/mL) | Baseline to Day 28 | |
Other | Pharmacodynamics biomarkers: C-reactive protein (CRP) | - Change in serum and plasma biomarkers (mg/L) | Baseline to Day 28 | |
Other | Pharmacodynamics biomarkers: Ferritin | - Change in serum and plasma biomarkers (mg/L) | Baseline to Day 28 | |
Other | Pharmacodynamics biomarkers: D-dimer | - Change in serum and plasma biomarkers (mg/L) | Baseline to Day 28 | |
Other | Virology | - Change in viral sequencing, resistance, infectivity using RT-qPCR | Baseline to Day 85 | |
Other | Patient Report Outcomes (PRO): Sponsor developed patient self-report COVID-19 symptom survey (PSRSS-C19) | - Change from baseline to Day 28 and safety follow-up visit in score ranging from 0 (none) to 3 (severe) | Baseline to Day 85 | |
Other | Patient Report Outcomes (PRO): Patient Global Impression of Severity (PGI-S) survey | - Change from baseline to Day 28 and safety follow-up visit in score ranging from 0 (non) to 4 (very severe) | Baseline to Day 85 | |
Other | Patient Report Outcomes (PRO): Patient Global Impression of Change (PGI-C) survey | - Change from baseline to Day 28 and safety follow-up visit in score ranging from 0 (much better) and 4 (much worse) | Baseline to Day 85 | |
Primary | Treatment emergent adverse events | Evaluated as per DAIDS v2.1 | Baseline to Day 85 | |
Secondary | Pharmacokinetic parameters of TB006: AUC(0-last) | - Area under the plasma concentration curve over time (hr*µg/mL) | Day 1 to Day 85 | |
Secondary | Pharmacokinetic parameters of TB006: Cmax | - Maximum concentration of TB006 (µg/mL) | Day 1 to Day 85 | |
Secondary | Pharmacokinetic parameters of TB006: Tmax | - The amount of time that TB006 is present at the maximum concentration (hours) | Day 1 to Day 85 | |
Secondary | Pharmacokinetic parameters of TB006: T1/2 | - Half life of TB006 (hours) | Day 1 to Day 85 | |
Secondary | Immunogenicity | - Anti-drug antibodies (ADA) | Day 1 to Day 85 | |
Secondary | Preliminary Efficacy: Viral shedding change | Change from baseline in viral shedding from Day 1 to Day 28, as measured by RT-qPCR | Day 1 to Day 28 | |
Secondary | 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 | Baseline to Day 28 | |
Secondary | Preliminary Efficacy: Time to viral shedding clearance | Measure the time to viral shedding clearance | Baseline to Day 85 | |
Secondary | 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 | Baseline to Day 28 | |
Secondary | Preliminary Efficacy: Total number of COVID-19 related medically-attended visits | Number of COVID-19 related medically-attended visits during study | Baseline to Day 28 | |
Secondary | Preliminary Efficacy: Proportion of treated patients admitted to a hospital due to COVID-19 | Proportion of patients admitted to a hospital by Day 28 | Baseline to Day 28 | |
Secondary | Preliminary Efficacy: Time to sustained clinical recovery from baseline | Time to sustained clinical recovery from baseline to end of follow-up visits | Baseline to Day 85 | |
Secondary | 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) | Baseline to Day 28 |
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