Corona Virus Infection, Covid19
Conditions
Brief summary
This is an interventional new drug clinical trial for a Phase 2 randomized, double-blind, and placebo control study using intravenous injection of allogeneic adipose stem cells (Celltex AdMSCs) for subjects with severe COVID-19.
Interventions
BIOLOGICALAllogeneic adipose-derived stem cells
Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue
Sponsors
Celltex Therapeutics Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
The Phase 2 study is a randomized, double blind and placebo control study conducted initially in a single clinic facility.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age above 18 years. * Male and female * Must understand and voluntarily sign an Informed Consent for study participation obtained prior to undergoing any study-specific procedures * Diagnosed as COVID-19 based upon SARS-CoV-2 RT-PCR test positive * Clinical diagnosis meets severe and/or critical parameters * Male participants must be willing to ensure their partners do not become pregnant either by practicing abstinence or the use of condoms during sexual activity
Exclusion criteria
* Participation in another clinical study (with use of another Investigational Medical Product) within 3 months prior to study treatment start * Unwillingness or inability to comply with study procedures * Patients with serious basic diseases that affect survival, including blood diseases, cachexia, active bleeding, severe malnutrition, etc. * Clinically active malignant disease * Subjects who are receiving ECMO and CRRT currently * History of known pulmonary embolism or known secondary anti-phospholipid syndrome * Known or suspected hypersensitivity to any components used to culture the AdMSCs, e.g. BSA and sulfur containing products (e.g., DMSO) * Known or suspected allergic to diphenhydramine. * Major trauma or surgery within 14 days of study treatment start * Mental condition rendering the subject (or the subject's legally acceptable representative\[s\]) unable to understand the nature, scope and possible consequences of the study * Alcohol, drug, or medication abuse within one year prior to study treatment start * Any condition that, in the Investigator's opinion, is likely to interfere with evaluation of the AdMSC therapy or satisfactory conduct of the study * Irreversible severe end organ failure, such as heart failure/attack, stroke, liver and renal failure due to other disease conditions * Patients or family history with hypercoagulable status, such as protein C/protein S deficiency, factor V Leiden, prothrombin gene mutation, dysfibrinogenemia, etc. * History of long-term use of immunosuppressive agents * Organ transplants in the past 6 months * Pregnant, breastfeeding, or desire to become pregnant or unwilling to practice birth control during participation in the study duration, unless surgically sterilized or postmenopausal during the study. * Patients with previous pulmonary obstructive pneumonia, severe pulmonary interstitial fibrosis, alveolar proteinosis, allergic alveolitis, and other known viral pneumonia or bacterial pneumonia before COVID-19 infection. The pulmonary imaging revealed the interstitial damage of lungs before the COVID-19 confirmed. * QT interval shows greater than 450 ms in males and 470 ms in females in the medical histories or during screen EKG test. * Subjects are not medically unstable at time of infusion including but not limiting unstable hypertension, pulse, oximetry, etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety for AdMSCs based upon incidence of all AEs | 6 months | Grouped by Medical Dictionary for Regulatory Activities (MedDRA) |
| Compare the mortality rate | 6 months | AdMSC treating group vs. control group |
| Safety of AdMSC injection will be evaluated by assessment of the frequency and nature of adverse events occurring during the study based on the rate of all AdMSC-associated adverse events (AEs) in all subjects. | 6 months | Incidence of treatment-related adverse events and severe adverse events during the study period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration (days) of weaning from mechanical ventilation | 6 months | Compared to control group |
| Duration (days) of ICU monitoring | 6 months | Compared to control group |
| Duration (days) of vasoactive agent's usage | 6 months | Compared to control group |
| Proportions of SARS-CoV-2 RT-PCR change to negative from respiratory tract specimens (oropharyngeal swabs) using CDC standard method | 6 months | Compared to control group |
| Proportions of quantifying viral RNA in stool change to negative in final follow-up using CDC standard method | 6 months | Compared to control group |
| Proportions of blood SARS-CoV-2 antibodies IgM/IgG show positive | 6 months | Compared to control group |
| Duration of hospitalization (days) | 6 months | Compared to control group |
| Recognized immune measurements evaluating patients' symptom changes and overall function | 6 months | To evaluate change of sequential organ failure assessment (SOFA) score as compare to the baseline |
| Organ functional tests including blood specific enzymes and proteins | 6 months | To evaluate the efficacy of allogeneic AdMSCs for COVID-19 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mortality rate down to 0% | 6 months | For severe and critical cases |
| Achieve at least 30% more proportion of severe patients in AdMSC study group without developing organ failure or recovery from previous organ failure | 6 months | Compared to control group |
Contacts
Primary ContactJane Young, Ph.D.
Outcome results
None listed