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.
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.
Biological: CAP-1002
100-mL (total volume) infusion of 150M CDCs in 5% Human Serum Albumin (HSA)
Other Name: Array
Biological: Placebo
Matching placebo solution
Inclusion Criteria:
1. Male or female subjects at least 18 years of age at time of consent.
2. Diagnosis of SARS-CoV-2 infection confirmed by real-time reverse transcription
polymerase chain reaction (RT-PCR) assay.
3. Compromised respiratory status as defined by arterial oxygen saturation < 92% (oxygen
saturation measured by pulse oximetry) OR cardiomyopathy due to COVID-19 (defined as a
new drop in ejection fraction to ≤ 50% during COVID-19 with no evidence of obstructive
coronary artery disease based on medical records review).
4. Elevation of at least 1 inflammatory marker (IL-1, IL-6, IL-10, TNF-α, ferritin, CRP)
defined as ≥ 2x upper limit of laboratory normal reference value.
5. Written informed consent provided by subject or legal representative.
Exclusion Criteria:
1. Currently receiving extracorporeal membrane oxygenation (ECMO) or high frequency
oscillatory ventilation (HFOV).
2. Patients who have been intubated.
3. Patients with established positive bacterial blood cultures prior to enrollment or
suspicion of superimposed bacterial pneumonia.
4. Patients with untreated human immunodeficiency virus (HIV) infection.
5. Creatinine clearance less than 30 mL/minute.
6. Liver function tests > 5x normal.
7. Current or history (within the previous 5 years) of systemic autoimmune or connective
tissue disease.
8. Known allergy or hypersensitivity to any of the IP constituents such as dimethyl
sulfoxide (DMSO) or bovine proteins.
9. Treatment with a cell therapy product within 12 months prior to randomization.
10. Participation in an ongoing protocol studying an experimental drug or device.
11. Pregnant or breastfeeding female subjects, and sexually active female subjects of
childbearing potential not willing to use contraceptive methods.
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California Davis
Sacramento, California, United States
Henry Ford Health System
Detroit, Michigan, United States
PharmaTex Research, LLC
Amarillo, Texas, United States
Tim Albertson, MD, Principal Investigator
UC Davis