Intravenous Infusion of CAP-1002 in Patients With COVID-19 (INSPIRE)
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|ClinicalTrials.gov Identifier: NCT04623671|
Recruitment Status : Completed
First Posted : November 10, 2020
Last Update Posted : March 31, 2022
|Condition or disease||Intervention/treatment||Phase|
|Covid19||Biological: CAP-1002 Biological: Placebo||Phase 2|
This is a randomized, double-blind, placebo-controlled Pilot, Phase 2 Exploratory study that will enroll subjects with a clinical diagnosis of COVID-19 confirmed by laboratory testing and who are in severe or critical condition as indicated by life-support measures. Prior to protocol procedures, informed consent will be obtained from the subject or a legally authorized representative. Subjects will undergo a screening evaluation to determine eligibility based on the protocol inclusion and exclusion criteria.
The primary objectives of the study are to determine the safety and effectiveness of intravenously infused CAP-1002 in improving clinical outcomes in severely or critically ill patients with COVID-19.
Eligible subjects will be randomized to either the CAP-1002 or placebo group (1:1 ratio) and undergo baseline safety and efficacy assessments approximately 1 to 5 days prior to the administration of investigational product (IP). Treatment administration consists of IP consisting of 150M CDCs or matching placebo on study Day 1. Background standard of care treatment and practices will be maintained for all patients enrolled in the study.
Subjects will complete Screening followed by a Treatment and Follow-up phase. A detailed medical history will be collected, including the presence of any co-morbidities and risk factors believed to be associated with COVID-19 outcomes or emergent factors since the time of infection. Eligibility must be reviewed and confirmed on Day 1 prior to the infusion of IP.
Subjects will be observed during the index hospitalization and monitored for outcome and safety with vital signs (heart rate, blood pressure, respiratory rate, and oxygen saturation), physical examinations, electrocardiograms, clinical laboratory testing including complete blood count and comprehensive metabolic panel, inflammatory markers and adverse events. Blood samples will be collected and submitted to a central laboratory for future proteomic assay assessment. Use of any concomitant medications to treat COVID-19 will be documented.
Follow-up will be conducted on Days 2, 3, 7, 15, 30, 60, and 90 either in the inpatient setting or by telephone if the subject has been discharged. All subject participation will be a maximum of 13 weeks from Screening.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Syringes (60-mL) with amber film-covered barrels|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Intravenous Infusion of CAP-1002 in Patients With COVID-19 (INSPIRE)|
|Actual Study Start Date :||November 15, 2020|
|Actual Primary Completion Date :||February 4, 2022|
|Actual Study Completion Date :||February 4, 2022|
Active Comparator: CAP-1002
The active pharmaceutical ingredient in CAP-1002 is Cardiosphere-Derived Cells (CDCs). CDCs are known to secrete numerous bioactive elements (growth factors, exosomes) which impact the therapeutic benefits of the cell-based therapy. The mechanism of action is the composite ability to be immunomodulatory, anti-fibrotic and regenerative.
100-mL (total volume) infusion of 150M CDCs in 5% Human Serum Albumin (HSA)
Placebo Comparator: Placebo
Matching placebo solution
Matching placebo solution
- Safety of CAP-1002: Incidence of All-Cause Mortality [ Time Frame: 90 days ]Number of all-cause mortality cases within 90 days from start of treatment
- Change in World Health Organization (WHO) Ordinal Scale of Clinical Improvement [ Time Frame: 30 days ]Absolute values and changes from start of treatment to Day 30 on the clinical status of the subject using a 0-8 scale where 0=uninfected (no clinical or virological evidence of infection) to 8=death
- Time to Clinical Improvement on the WHO Ordinal Scale of Improvement [ Time Frame: 90 days ]Time to a 1-point decrease (indicative of improvement) on the WHO Ordinal Scale of Clinical Improvement from start of treatment
- Severity versus Time [ Time Frame: 30 days ]Area under the severity versus time curve, where severity is defined by the Ordinal Scale of Improvement and time is measured from start of treatment to Day 30
- Time on supplemental oxygen or mechanical ventilation [ Time Frame: 90 days ]Days on supplemental oxygen or ventilation since start of treatment
- Number of Intensive Care Unit (ICU) Discharges [ Time Frame: 30 days ]First ICU discharge within 30 days from start of treatment
- Number of Days in ICU [ Time Frame: 90 days ]Duration in ICU from start of treatment (up to 90 days)
- Number of Hospital Discharges [ Time Frame: 30 days ]Number of hospital discharges within 30 days from start of treatment
- Number of Days in Hospital [ Time Frame: 90 days ]Hospitalization length from start of treatment up to Day 90
- Changes in severity of Acute Respiratory Distress Syndrome (ARDS) by Berlin Criteria [ Time Frame: 30 days ]Absolute values and changes from start of treatment in severity in ARDS as defined by Berlin criteria: 0=none, 2=moderate, 3=severe
- Change in levels of cytokines: IL-1, IL-6, TNF-alpha, INF-gamma, IL-10 [ Time Frame: 30 days ]Cytokine assay absolute values and changes from start of treatment to Day 30
- Changes in levels of biomarkers: C-Reactive Protein, troponin I, myoglobin, ferritin, procalcitonin [ Time Frame: 30 days ]Biomarker assay absolute values and changes from start of treatment to Day 30
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04623671
|United States, California|
|Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|University of California Davis|
|Sacramento, California, United States, 95817|
|United States, Michigan|
|Henry Ford Health System|
|Detroit, Michigan, United States, 48202|
|United States, Texas|
|PharmaTex Research, LLC|
|Amarillo, Texas, United States, 79109|
|Principal Investigator:||Tim Albertson, MD||UC Davis|