NCT04398303

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2020

Shorter than P25 for phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 21, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

May 21, 2020

Status Verified

May 1, 2020

Enrollment Period

5 months

First QC Date

May 20, 2020

Last Update Submit

May 20, 2020

Conditions

COVID-19 Pneumonia

Keywords

Stem cellsPneumoniaCOVIDCOVID-19CoronavirusSARS-CoV-2

Outcome Measures

Primary Outcomes (1)

  • Mortality at day 30

    30 days post treatment

Secondary Outcomes (7)

  • Ventilated Subjects - Ventilator Free Days

    28 days post treatment

  • Ventilated Subjects - Improvement in Ventilator Settings

    28 days post treatment, or until off of ventilator

  • High-Flow O2 Support Subjects - Step-Down O2 Therapy

    30 days post treatment, or until off of high-flow O2 support

  • High Flow O2 Support Subjects - Respiration Rate

    30 days post treatment, or until off of high-flow O2 support

  • Both Ventilated and High-Flow O2 Support Subjects - ICU-Free Days

    30 days post treatment, or until off of ventilator or high-flow O2 support

  • +2 more secondary outcomes

Study Arms (3)

ACT-20-MSC in ACT-20-CM

EXPERIMENTAL

Conventional treatment plus ACT-20-MSC in ACT-20-CM administered intravenously

Biological: ACT-20-MSC

ACT-20-CM

EXPERIMENTAL

Conventional treatment plus ACT-20-CM administered intravenously

Biological: ACT-20-CM

Placebo

PLACEBO COMPARATOR

Conventional treatment plus placebo (MEM-α) administered intravenously

Biological: Placebo

Interventions

ACT-20-MSCBIOLOGICAL

1 million cells / kg body weight in 100 ml in conditioned media

ACT-20-MSC in ACT-20-CM
ACT-20-CMBIOLOGICAL

100 ml of conditioned media only

ACT-20-CM
PlaceboBIOLOGICAL

100 ml of MEM-α

Placebo

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • 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).
  • Positive end-expiratory airway pressure (PEEP) ≥ 5 cmH2O
  • Oxygen saturation ≤ 93%
  • 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

You may not qualify if:

  • 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:
  • PaCO2 \> 50 mm Hg, or
  • history of use of home oxygen
  • 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)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

PneumoniaCOVID-19Coronavirus Infections

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesPneumonia, ViralVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus Infections

Central Study Contacts

Laura Fairbairn

CONTACT

403-921-5854regulatory@aspire2cure.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2020

First Posted

May 21, 2020

Study Start

May 1, 2020

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

May 21, 2020

Record last verified: 2020-05