Coronavirus Disease 2019 COVID-19 Clinical Trial
Official title:
A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of TJ003234 in Subjects With Severe Coronavirus Disease 2019 (COVID-19)
| Verified date | May 2023 |
| Source | I-Mab Biopharma Co. Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a randomized, double-blind, placebo-controlled, multi-center trial to evaluate the safety and efficacy of TJ003234 administered as an intravenous (IV) infusion in subjects with severe COVID-19 under supportive care, and to assess the effect of TJ003234 on the levels of cytokines.
| Status | Completed |
| Enrollment | 149 |
| Est. completion date | February 7, 2022 |
| Est. primary completion date | February 7, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Age: 18 years or older (including 18 years); male or female - Laboratory-confirmed SARS-CoV-2 or COVID-19 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay. - Bilateral lung infection confirmed by imaging. - Severe disease that meets one of the following conditions: (i) At rest, finger blood oxygen saturation = 93% or PaO2/FiO2 = 300 mmHg; (ii) Requiring non-invasive or invasive mechanical ventilation; OR (iii) Requiring high flow oxygen = 15L/min - Hospitalized for no more than 5 calendar days at the time of screening Exclusion Criteria: - Any previous and/or current clinically significant disease or condition that has not been stable within 3 months prior to enrollment, or acute illness, planned medical/ surgical procedure, or any trauma that occurred within 2 weeks prior to enrollment. - Chronic obstructive pulmonary disease (COPD) patients requiring inhaled corticosteroid, long-acting beta-adrenergic agonists, long-acting anticholinergics, or long-term oxygen therapy (Part 1 only). - Pulmonary interstitial disease, pulmonary alveolar proteinosis, and pulmonary granulomatosis. - Cardiovascular event in the 3 months prior to study drug administration: acute myocardial infarction or unstable angina pectoris, severe arrhythmia (multiple sources of frequent ventricular premature beat, ventricular tachycardia and ventricular fibrillation); New York Heart Association Classification (NYHA): Class III-Class IV. - Blood system disorders or routine blood analysis test abnormalities: Hemoglobin < 8 g/dL; Absolute neutrophil count (ANC) <1500 × 109/L; Platelets < 50 × 109/L. - Dependence on glucocorticoid treatment equivalent to methylprednisolone 2 mg/kg/ day or more or long-term use of anti-rejection or immunomodulatory drugs. - Subjects that have been on invasive mechanical ventilation for =120 hours at the time of dosing - Subjects that require ECMO. - Pregnant or breastfeeding females. |
| Country | Name | City | State |
|---|---|---|---|
| United States | UNM Hospitals | Albuquerque | New Mexico |
| United States | Brigham and Women's Hospital | Boston | Massachusetts |
| United States | Houston Methodist Hospital | Houston | Texas |
| United States | Indiana University Health | Indianapolis | Indiana |
| United States | University of Mississippi Medical Center | Jackson | Mississippi |
| United States | University Medical Center of Southern Nevada | Las Vegas | Nevada |
| United States | University of Arkansas | Little Rock | Arkansas |
| United States | Medpharmics, LLC | Metairie | Louisiana |
| United States | University of Miami | Miami | Florida |
| United States | Ochsner Medical Center | New Orleans | Louisiana |
| United States | OSF Healthcare Saint Francis Medical Center | Peoria | Illinois |
| United States | Olive View-UCLA Medical Center | Sylmar | California |
| United States | Georgetown University Hospital | Washington | District of Columbia |
| United States | The GW Medical Faculty Associates | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| I-Mab Biopharma Co. Ltd. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Subjects Alive and Free of Mechanical Ventilation Among Subjects Who Are Free of Mechanical Ventilation at Baseline | Free of mechanical ventilation was defined as proportion of subjects who scores 1 to 5 in the following 8-category ordinal scale.
8, death; 7, ventilation in addition to extracorporeal membrane oxygen (ECMO), continuous renal replacement therapy (CRRT) or pressors; 6, intubation and mechanical ventilation; 5, non-invasive mechanical ventilation (NIV) or high-flow oxygen; 4, hospitalization with oxygen by mask or nasal prongs; 3. Hospitalization without oxygen supplementation; 2, limitation of activities, discharge from hospital; and 1, no limitation of activities, discharge from hospital. |
Day 1 through Day 30 | |
| Secondary | Percentage of Recovery by Day 14 | Sustained recovery in clinical status was defined as patients who have hospitalization without oxygen supplement or discharge from hospital. | Day 1 through Day 14 | |
| Secondary | Percentage of Subjects Recovered on Day 30 | Sustained recovery in clinical status was defined as patients who have hospitalization without oxygen supplement or discharge from hospital. | Day 1 through Day 30 | |
| Secondary | All-cause Mortality Rate by Day 30 | The percentage of subjects who deceased by any cause. | Day 1 through Day 30 | |
| Secondary | Time to Recovery Among Subjects Alive by Day 30 | Time to sustained recovery | Day 1 through Day 30 | |
| Secondary | Length of Hospitalization | Duration of hospitalization | Day 1 through Day 30 |