ASC Therapy for Patients With Severe Respiratory COVID-19 (ASC COVID-19)

• ClinicalTrials.gov Identifier: NCT04341610
• Recruitment Status: Withdrawn
• First Posted: April 10, 2020
• Last Update Posted: May 27, 2020
• Sponsor: Rigshospitalet, Denmark
• Information provided by (Responsible Party): JKastrup, Rigshospitalet, Denmark

Tracking Information

• First Submitted Date: April 7, 2020
• First Posted Date: April 10, 2020
• Last Update Posted Date: May 27, 2020
• Estimated Study Start Date: April 20, 2020
• Estimated Primary Completion Date: January 30, 2021 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 9, 2020): Changes in clinical critical treatment index [ Time Frame: day 7 from randomization ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 9, 2020)

• Days of respirator treatment [ Time Frame: 3 months ]
• Improvement of clinical symptoms including duration of fever and respiratory need [ Time Frame: 3 months ]
• Mortality [ Time Frame: 3 months ]
• Marker of Immunological function -CD4+ and CD8+ T cell count [ Time Frame: 3 months ]
• C-reactive protein and leucocyte [ Time Frame: 3 months ]
• Cytokine profile [ Time Frame: 3 months ]
• Glomerular Filtration Rate [ Time Frame: 3 months ]
• Duration of hospitalization [ Time Frame: 3 months ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: ASC Therapy for Patients With Severe Respiratory COVID-19
• Official Title: Allogeneic Adipose Tissue Derived Mesenchymal Stromal Cell Therapy for Treating Patients With Severe Respiratory COVID-19. A Danish, Double-blind, Randomized Placebo-controlled Study

Brief Summary

The emerging field of stem cell therapy holds promise of treating a variety of diseases. Especially the mesenchymal stromal cells from bone marrow or adipose tissue (ASCs) have proven their potential for regenerative therapy in patients with ischemic heart disease. Both of these cell types have putative immunomodulatory properties, as they have demonstrated their ability to evade recognition and actively suppress the immune system.

This knowledge is transferred into studies with COVID-19 patients having severe pulmonary dysfunction, to modify the virus induced immunological and inflammatory activity involved in the progression of disease often leading to prolonged ICU stay and in some occasion's death.

We will conduct a clinical trial in which patients with COVID-19 and severe pulmonary symptoms will be randomized to either placebo or treatment with allogeneic CSCC_ASCs from adipose tissue. The aim is to assess the impact of CSCC_ASCs on the activated immune system and clinical efficacy on pulmonary function.

The perspective is that this new information can be of pivotal importance and potentially be a paradigm shift for the clinical problems and severe outcome seen in some patients with severe COVID-19 and other severe diseases with Acute Respiratory Distress Syndrome.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Double-blind placebo-controlled

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

Double-blind placebo-controlled

Primary Purpose: Treatment

• Condition: Respiratory Tract Diseases

Intervention

Drug: Stem Cell Product

100 million allogeneic adipose-derived mesenchymal stromal cells diluted in 100 ml saline

Study Arms

• Active Comparator: ASC
  100 million allogeneic adipose-derived mesenchymal stromal cell
  Intervention: Drug: Stem Cell Product
• Placebo Comparator: Placebo
  Saline
  Intervention: Drug: Stem Cell Product

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: May 25, 2020): 0
• Original Estimated Enrollment (submitted: April 9, 2020): 40
• Estimated Study Completion Date: April 30, 2021
• Estimated Primary Completion Date: January 30, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients between 18-80 years
• Confirmed HCoV-19 infection
• Temperature above 38.0o C

• Pulmonary symptoms and signs, at least one of the following before clinical decision for intubation and respirator treatment:

  1. Respiratory distress, RR ≥ 30/min;
  2. Oxygen saturation ≤ 93% at rest state;
  3. Arterial partial pressure of oxygen (PaO2) / Fraction of inspiration O2 (FiO2) ≤ 300mmHg, 1mmHg=0.133kPa
• Pneumonia that is judged by chest radiograph or computed tomography
• In respirator and possible for treatment within the first 24 hours

Exclusion Criteria:

• Patients that have need for additional immunosuppressive treatment
• Patients with any past (within the past 3-5 years) or present malignancy (other than excised basal cell carcinoma).
• Co-Infection with other infectious agent.
• Females capable of becoming pregnant must have a negative pregnancy test prior to treatment. After inclusion, they must use contraceptives for 2 months following the given stem cell treatment. The pill, spiral, depot injection of progesterone, sub-dermal implantation, hormonal vaginal ring and transdermal patch regarded as safe contraceptives.
• Patients who are participating in other clinical trials.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT04341610
• Other Study ID Numbers: EudraCT number: 2020-001330-36
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: JKastrup, Rigshospitalet, Denmark
• Original Responsible Party: Same as current
• Current Study Sponsor: Rigshospitalet, Denmark
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Rigshospitalet, Denmark
• Verification Date: May 2020