Tregs for the Treatment of Acute Respiratory Distress Syndrome (ARDS) Associated With COVID-19 (regARDS)
Condition: Acute Respiratory Distress Syndrome Due to Disease Caused by 2019-nCoV
MeSH terms: COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Intervention: Cryopreserved Ex Vivo Expanded Polyclonal CD4+CD127lo/-CD25+ T Regulatory Cells
Intervention description: cryopreserved cellular therapy product in cryostor CS5, for IV infusion
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      In patients with Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19
      inflammatory syndrome, the administration of Treg cells is a novel treatment complementary to
      other pharmacologic interventions that potentially can reduce lung inflammation, promote lung
      tissue repair, and significantly improve clinical outcomes. This trial is to evaluate the
      impact of a single IV dose of cePolyTregs given to ARDS patients with COVID-19 inflammatory
      syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of ARDS and respiratory failure requiring mechanical ventilation for less
             than 72 hours at the time of enrollment

          -  PaO2/FiO2 < 300 and PEEP > 5

          -  Male or female, age 18 to 70 years at Screening

          -  Weight > 40 kg

          -  Documented diagnosis of infection with SARS-CoV-2 virus by PCR

          -  Chest imaging (radiograph or CT scan) with abnormalities consistent with COVID-19
             pneumonia that could not be explained by effusions, pulmonary collapse, or nodules;
             and respiratory failure that could not be explained by cardiac failure or fluid
             overload

          -  Females of childbearing potential and males must use effective contraception practices
             from Screening until 28 days after the EOS visit

          -  Females of childbearing potential must have a negative pregnancy test at Screening and
             within 24 hours prior to dosing of study drug

          -  Able to provide Informed Consent, either by self or by medical proxy

          -  Willing and able to comply with this protocol for the entire duration of the study

        Exclusion Criteria:

          -  Any history or sign of significant chronic active or recurrent infection or screening
             laboratory evidence consistent with a significant chronic active or recurrent
             infection requiring treatment with antibiotics, antivirals or antifungals (other than
             SARS-CoV-2); ongoing antimicrobial treatments will not be exclusionary if, in the
             opinion of the investigator, no active infection is present (other than SARS-CoV-2)

          -  Receiving extracorporeal membrane oxygenation therapy

          -  Moribund patients not expected to survive 24 hours after enrollment based on clinical
             assessment

          -  History of significant underlying pulmonary disease (requiring home oxygen), renal
             disease (requiring dialysis for chronic kidney disease), hepatic disease (Child-Pugh
             score ≥ 7), or known history of cirrhosis.

          -  Known or suspected immunodeficiency disease

          -  Positive serology for HBV, HCV, or HIV at Screening

          -  Abnormal CBC defined by:

               -  Platelet count < 75,000/mm3

               -  White blood cell count < 2500/mm3

               -  Absolute neutrophil count < 500/mm3

          -  History of bone marrow or stem cell transplantation

          -  Received any type of live attenuated vaccine < 1 month prior to Screening or is
             planning to receive any such live attenuated vaccine over the course of the study

          -  History of lung cancer or any other malignancy requiring active treatment, except
             adequately treated basal cell carcinoma or in situ carcinoma of the uterine cervix

          -  Any female who is pregnant or breastfeeding, or any female who is planning to become
             pregnant during the study and follow-up period

          -  Any condition that, in the investigator's opinion, may compromise study participation,
             present a safety risk to the subject, or may confound the interpretation of the study
             results

          -  A QT duration corrected for heart rate by Fridericia's formula (QTcF) > 450
             millisecond (msec) for males or > 470 msec for females, based on either single or
             averaged QTcF values of triplicate ECGs obtained over a 3-minute interval

          -  Currently enrolled in another investigational device or drug study