Status:
TERMINATED
Study of the Safety of Therapeutic Tx With Immunomodulatory MSC in Adults With COVID-19 Infection Requiring Mechanical Ventilation
Lead Sponsor:
ImmunityBio, Inc.
Conditions:
COVID
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
This is a phase 1b randomized, double-blind, placebo-controlled study in adult subjects with Coronavirus Disease 2019 (COVID-19). This clinical trial will evaluate the preliminary safety and efficacy ...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old.
- Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines. For subjects that are intubated and/or sedated, or otherwise unable to provide consent, prospective consent from a legally-authorized representative is required. The subject or his/her legally authorized representative must be able to provide consent.
- Has laboratory-confirmed positive novel coronavirus (SARS-CoV-2) test, as determined by polymerase chain reaction (PCR), or other commercial or public health assay in any specimen \< 72 hours prior to enrollment, or meets the criteria to guide the evaluation and testing of patients under investigation (PUI) for COVID-19 (https://emergency.cdc.gov/han/2020/HAN00428.asp).
- Requiring mechanical ventilatory support with moderate to severe Acute Respiratory Distress Syndrome (ARDS) as determined by the Berlin criteria:
- Bilateral opacities present on a chest radiograph or computed tomographic (CT) scan. These opacities are not fully explained by pleural effusions, lobar collapse, lung collapse, or pulmonary nodules.
- Origin of Edema: Respiratory failure not fully explained by cardiac failure or fluid overload.
- Oxygenation: Moderate to severe impairment of oxygenation must be present, as defined by the ratio of arterial oxygen tension to fraction of inspired oxygen (PaO2/FiO2). The severity of the hypoxemia defines the severity of the ARDS:
- Moderate: PaO2/FiO2 \>100 mmHg and ≤ 200 mmHg, on ventilator settings that include PEEP ≥ 5 cm H2O
- Severe: PaO2/FiO2 ≤100 mmHg on ventilator settings that include PEEP ≥5 cm H2O Subjects receiving extracorporeal membrane oxygenation (ECMO) will not be enrolled in this study.
- High-sensitivity C-reactive Protein (hs-CRP) serum level \> 4.0 mg/dL
- Acute Physiology and Chronic Health Evaluation (APACHE IV) score \> 5
- Agrees to the collection of nasopharyngeal (NP) swabs and venous blood per protocol.
- Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
- Agreement to practice effective contraception for female subjects of child-bearing potential and non-sterile males. Female subjects of child-bearing potential must agree to use effective contraception while on study and for at least 1 month after the last dose of BM-Allo.MSC. Non-sterile male subjects must agree to use a condom while on study and for up to 1 month after the dose of BM-Allo.MSC. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterine devices (IUDs), oral contraceptives, and abstinence.
Exclusion
- Known hypersensitivity to any component of the study medication(s).
- Signs of multisystem organ failure. Liver function tests (LFTs) \> 5x normal.
- Intubated \> 72 continuous hours.
- Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
- Pregnant and nursing women. A negative serum pregnancy test during screening (within 72 hours prior to the first dose) must be documented before MSCs are administered to a female subject of child-bearing potential.
Key Trial Info
Start Date :
August 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 6 2020
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04397796
Start Date
August 3 2020
End Date
September 6 2020
Last Update
September 5 2024
Active Locations (1)
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1
St. Francis Medical Center
Lynwood, California, United States, 90262