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ACT-20 in Patients With Severe COVID-19 Pneumonia

A

Aspire Health Science

Status and phase

Unknown
Phase 2
Phase 1

Conditions

COVID-19 Pneumonia

Treatments

Biological: ACT-20-MSC
Biological: Placebo
Biological: ACT-20-CM

Study type

Interventional

Funder types

Other

Identifiers

NCT04398303
AHS 20-03

Details and patient eligibility

About

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

70 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Male or female patients age 18 to 85, inclusive

  2. Confirmed positive test for COVID-19 by standard reverse transcriptase polymerase chain reaction (RT-PCR) assay or equivalent

  3. On mechanical ventilation (n=35), or high-flow O2 support (n=35) and:

    1. Disease severity level of "moderate" (PaO2/FiO2 of 100-200) (n=35), or "severe" (PaO2/FiO2 < 100) (n=35) as established using the Berlin Criteria for ARDS (Barbas, Isola & Caser, 2014; Baron & Levy, 2016).
    2. Positive end-expiratory airway pressure (PEEP) ≥ 5 cmH2O
    3. Oxygen saturation ≤ 93%
  4. Non-cardiogenic bilateral pulmonary edema on frontal chest radiograph that cannot be explained by effusion, collapsed lung or lung nodule

  5. Able to understand and provide voluntary informed consent

Exclusion criteria

  1. Unable to understand and provide voluntary informed consent

  2. Current infection with HIV-1, HIV-2, Hepatitis B, Hepatitis C or HTLV

  3. History of malignancy, other than non-melanoma skin cancer or non-metastatic prostate cancer

  4. Currently receiving extracorporeal life support or high-frequency oscillatory ventilation

  5. Weight > 150 kg

  6. Current severe chronic respiratory disease, as demonstrated by:

    1. PaCO2 > 50 mm Hg, or
    2. history of use of home oxygen
  7. Major trauma within the past 7 days

  8. Lung transplant recipient

  9. WHO Class III or IV pulmonary hypertension

  10. Documented deep vein thrombosis or pulmonary embolism within the past 3 months

  11. Currently pregnant or lactating

  12. Currently participating in another clinical trial, or participation in another clinical trial within 30 days of enrollment

  13. Hypersensitivity to Dextran-40 or Dimethyl Sulfoxide (DMSO)

  14. Current pharmacotherapy using hydroxychloroquine or Interleukin-6 inhibitors

  15. History of CVA or MI within 180 days of study enrollment

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

70 participants in 3 patient groups, including a placebo group

ACT-20-MSC in ACT-20-CM
Experimental group
Description:
Conventional treatment plus ACT-20-MSC in ACT-20-CM administered intravenously
Treatment:
Biological: ACT-20-MSC
ACT-20-CM
Experimental group
Description:
Conventional treatment plus ACT-20-CM administered intravenously
Treatment:
Biological: ACT-20-CM
Placebo
Placebo Comparator group
Description:
Conventional treatment plus placebo (MEM-α) administered intravenously
Treatment:
Biological: Placebo

Trial contacts and locations

0

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Central trial contact

Laura Fairbairn

Data sourced from clinicaltrials.gov

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