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The primary objective of this study is determine the safety and efficacy of ACT-20-MSC (allogenic human umbilical derived mesenchymal stem cells) and ACT-20-CM (allogenic human umbilical derived mesenchymal stem cells in conditioned media) in patients with moderate to severe COVID-19 pneumonia.
Full description
This study will assess the safety and efficacy of ACT-20-MSC and ACT-20-CM administered intravenously to subjects with moderate to severe COVID-19 related pneumonia in two parts.
Part 1 is an open-label study of 10 subjects, 5 with moderate COVID-19 pneumonia and 5 with severe COVID-19 pneumonia. Of these 10 subjects, 5 will receive ACT-20-CM and 5 will receive ACT-20-MSC resuspended in ACT-20-CM.
Part 2 is a randomized, blinded, placebo-controlled study of 60 patients, 30 with moderate COVID-19 pneumonia and 30 with severe COVID-19 pneumonia. Randomization will be 1:1:1 ACT-20-MSC in ACT-20-CM, ACT-20-CM or placebo. The placebo is MEM-α, a widely used sterile culture media that contains non-essential amino acids, nucleosides, vitamins, glucose, sodium pyruvate and lipoic acid.
Subjects treated at each investigative site will provide written informed consent prior to the conduct of any study-related procedures. Thereafter, they will be screened and those meeting the inclusion/exclusion criteria will be enrolled into the trial and undergo all the study procedures including the intravenous administration of the investigational medical product (IMP = ACT-20-MSC in ACT-20-CM or ACT-20-CM) or placebo. The IMP will be administered in addition to any standard of care treatment the subject is receiving.
Subjects will be assessed daily while in hospital. Following discharge from hospital, subjects will be following for an additional three month period.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Male or female patients age 18 to 85, inclusive
Confirmed positive test for COVID-19 by standard reverse transcriptase polymerase chain reaction (RT-PCR) assay or equivalent
On mechanical ventilation (n=35), or high-flow O2 support (n=35) and:
Non-cardiogenic bilateral pulmonary edema on frontal chest radiograph that cannot be explained by effusion, collapsed lung or lung nodule
Able to understand and provide voluntary informed consent
Exclusion criteria
Unable to understand and provide voluntary informed consent
Current infection with HIV-1, HIV-2, Hepatitis B, Hepatitis C or HTLV
History of malignancy, other than non-melanoma skin cancer or non-metastatic prostate cancer
Currently receiving extracorporeal life support or high-frequency oscillatory ventilation
Weight > 150 kg
Current severe chronic respiratory disease, as demonstrated by:
Major trauma within the past 7 days
Lung transplant recipient
WHO Class III or IV pulmonary hypertension
Documented deep vein thrombosis or pulmonary embolism within the past 3 months
Currently pregnant or lactating
Currently participating in another clinical trial, or participation in another clinical trial within 30 days of enrollment
Hypersensitivity to Dextran-40 or Dimethyl Sulfoxide (DMSO)
Current pharmacotherapy using hydroxychloroquine or Interleukin-6 inhibitors
History of CVA or MI within 180 days of study enrollment
Primary purpose
Allocation
Interventional model
Masking
70 participants in 3 patient groups, including a placebo group
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Central trial contact
Laura Fairbairn
Data sourced from clinicaltrials.gov
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