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Study of the Safety of Therapeutic Tx With Immunomodulatory MSC in Adults With COVID-19 Infection Requiring Mechanical Ventilation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04397796
Recruitment Status : Active, not recruiting
First Posted : May 21, 2020
Last Update Posted : February 1, 2022
Sponsor:
Information provided by (Responsible Party):
ImmunityBio, Inc.

Tracking Information
First Submitted Date  ICMJE May 18, 2020
First Posted Date  ICMJE May 21, 2020
Last Update Posted Date February 1, 2022
Actual Study Start Date  ICMJE August 3, 2020
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2020)
  • Incidence of AEs [ Time Frame: 30 days ]
    Incidence of AEs within 30 days of randomization.
  • Mortality [ Time Frame: 30 days ]
    Mortality within 30 days of randomization.
  • Death [ Time Frame: 30 days ]
    Cause of death within 30 days of randomization
  • Number of ventilator-free days [ Time Frame: 60 days ]
    Number of ventilator-free days within 60 days of randomization.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2020)
  • Improvement of one category [ Time Frame: 30 days ]
    Time from randomization to an improvement of one category using the ordinal scale. The ordinal scale is as follows:
    1. Death
    2. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
    3. Hospitalized, on non-invasive ventilation or high flow oxygen devices
    4. Hospitalized, requiring supplemental oxygen
    5. Hospitalized, not requiring supplemental oxygen
    6. Not hospitalized, limitation on activities
    7. Not hospitalized, no limitations on activities
  • 7-point ordinal scale [ Time Frame: 30 days ]
    Change in the 7-point ordinal scale from baseline. The ordinal scale is as follows:
    1. Death
    2. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
    3. Hospitalized, on non-invasive ventilation or high flow oxygen devices
    4. Hospitalized, requiring supplemental oxygen
    5. Hospitalized, not requiring supplemental oxygen
    6. Not hospitalized, limitation on activities
    7. Not hospitalized, no limitations on activities
  • NEWS [ Time Frame: 30 days ]
    Change in NEWS from baseline. The following 7 clinical parameters will be assessed:
    1. Respiration rate
    2. Oxygen saturation
    3. Any supplemental oxygen
    4. Temperature
    5. Systolic blood pressure
    6. Heart rate
    7. Level of consciousness
    Measurements within normal ranges are assigned a 0. If the measurement in each category is substantially above or below the normal range, it is given a +1, +2, or +3. The more far off than normal, the bigger the number (in each category). A higher number indicates worse outcome. Each category can be 0-3, except for supplemental oxygen which is only 0-2. The highest value a patient can get is 20.
  • NEWS of ≤ 2 [ Time Frame: 30 days ]
    Time from randomization to discharge or to a NEWS of ≤ 2 maintained for 24 hours, whichever occurs first.
  • Sequential Organ Failure Assessment (SOFA) [ Time Frame: days 8, 15, 22, and 29 ]
    Change from baseline in Sequential Organ Failure Assessment (SOFA) score on days 8, 15, 22, and 29. System Score for each category is 0-4 with 28 is the maximum score for worst outcome. The following categories are:
    1. Respiration
    2. Coagulation
    3. Liver
    4. Cardiovascular
    5. Central Nervous System
    6. Renal
  • Oxygen [ Time Frame: 30 days ]
    Number of days requiring oxygen.
  • Hospitalization [ Time Frame: 30 days ]
    Duration of hospitalization from randomization.
  • Incidence of SAEs [ Time Frame: 30 days ]
    Incidence of SAEs within 30 days of randomization
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Safety of Therapeutic Tx With Immunomodulatory MSC in Adults With COVID-19 Infection Requiring Mechanical Ventilation
Official Title  ICMJE Phase 1b Randomized, Double-Blind, Placebo-Controlled Study Of The Safety Of Therapeutic Treatment With Immunomodulatory Mesenchymal Stem Cells In Adults With COVID-19 Infection Requiring Mechanical Ventilation
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 of BM-Allo.MSC vs placebo in treating subjects with severe disease requiring ventilator support during COVID 19 infection.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE COVID
Intervention  ICMJE
  • Biological: BM-Allo.MSC
    BM-Allo.MSC for Infusion, is manufactured from normal donor derived bone marrow product and are phenotypically CD73+, CD90+, CD105+, and negative for CD14-, CD34-, CD45-, HLA-DR-.
  • Biological: Placebo
    plasmalyte and human albumin
Study Arms  ICMJE
  • Experimental: BM-Allo.MSC
    Subjects in the experimental arm will be administered BM-Allo.MSC
    Intervention: Biological: BM-Allo.MSC
  • Placebo Comparator: Placebo
    Subjects in the control arm will be treated with placebo
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 19, 2020)
45
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥ 18 years old.
  2. 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.
  3. 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).
  4. Requiring mechanical ventilatory support with moderate to severe Acute Respiratory Distress Syndrome (ARDS) as determined by the Berlin criteria:

    1. 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.
    2. Origin of Edema: Respiratory failure not fully explained by cardiac failure or fluid overload.
    3. 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.
  5. High-sensitivity C-reactive Protein (hs-CRP) serum level > 4.0 mg/dL
  6. Acute Physiology and Chronic Health Evaluation (APACHE IV) score > 5
  7. Agrees to the collection of nasopharyngeal (NP) swabs and venous blood per protocol.
  8. Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
  9. 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 Criteria:

  1. Known hypersensitivity to any component of the study medication(s).
  2. Signs of multisystem organ failure. Liver function tests (LFTs) > 5x normal.
  3. Intubated > 72 continuous hours.
  4. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
  5. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04397796
Other Study ID Numbers  ICMJE QUILT-COVID-19-MSC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party ImmunityBio, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE ImmunityBio, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ImmunityBio, Inc.
Verification Date February 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP