NCT04361942

Brief Summary

Novel coronavirus disease COVID-19, produced by SARS-CoV-2, has become a health emergency around the world. Since first patients were detected in Wuhan (China), in December 2019, COVID-19 has spread quickly worldwide, being a severe threat to public health. Fever, dry cough, shortness of breath and breathing distress are the main characteristics of COVID-19 infection. Some patients develop overwhelming lung inflammation and acute respiratory failure, for which there is no specific therapy. Therefore, safe and effective treatment for COVID-19 pneumonia is utterly necessary, mainly in critical cases. Mesenchymal stem/stromal cells (MSCs) have been widely used in the immune-mediated inflammatory diseases. MSCs can regulate both innate and adaptive immunity by suppressing the proliferation, differentiation and activation of different cells. These immunomodulatory properties of MSCs support performance of the double-blind, placebo-controlled, randomized, phase I/II clinical trial to evaluate safety and efficacy of allogeneic MSCs for treatment of severe COVID-19 pneumonia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 17, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2021

Completed
Last Updated

February 2, 2024

Status Verified

January 1, 2024

Enrollment Period

1.5 years

First QC Date

April 17, 2020

Last Update Submit

January 31, 2024

Conditions

COVID-19 Pneumonia

Keywords

COVID-19Mesenchymal Stromal CellsMesenchymal Stem CellsMSV

Outcome Measures

Primary Outcomes (2)

  • Proportion of patients in whom removal of invasive mechanical ventilation (IMV) has been achieved

    Index of therapy success to preserve Intensive Care Unit (ICU) space.

    0-7 days

  • Overall survival

    To measure global success

    0-28 days

Secondary Outcomes (4)

  • Complete clinical response

    0-Event/Loss to follow-up

  • Complete radiological response

    0-28 days

  • Radiological improvement of pulmonary images

    0-5 days

  • Removal of invasive mechanical ventilation (IMV)

    0-28 days

Other Outcomes (3)

  • Levels of cytokines and other inflammatory markers in peripheral blood

    0-7 days

  • Levels of circulating immune cells

    0-7 days

  • Levels of renal and liver function markers

    0-7 days

Study Arms (2)

Mesenchymal Stem Cells (MSCs)

EXPERIMENTAL

Intravenous injection of 1 million MSCs (MSV cells)/Kg suspended in 100 ml of physiological saline solution.

Biological: Mesenchymal Stem Cells (MSCs)

Placebo

PLACEBO COMPARATOR

Intravenous injection of 100 ml of physiological saline solution containing no cells

Other: Placebo

Interventions

Mesenchymal Stem Cells (MSCs)BIOLOGICAL

Intravenous injection of 1 million MSCs (MSV cells)/Kg suspended in 100 ml physiological saline solution.

Also known as: MSV (GMP-compliant MSCs manufactured by IBGM in Valladolid)
Mesenchymal Stem Cells (MSCs)
PlaceboOTHER

Intravenous injection of 100 ml physiological saline solution containing no cells

Also known as: Saline
Placebo

Eligibility Criteria

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

You may qualify if:

  • Women or men of ≥ 18 years of age
  • SARS-CoV-2 infection confirmed by molecular testing.
  • Admitted to the Intensive Care Unit with pneumonia by COVID-19 infection and intubated in the last 48 hours, that meet at least one of these criteria:
  • Respiratory distress.
  • Respiratory rate (RR) ≥ 30 rpm.
  • Basal oxygen saturation at rest ≤ 93%.
  • Arterial partial pressure of oxygen (PaO2) / inspiratory fraction of oxygen (FiO2) ≤ 300 mmHg.
  • Consent of the patient or his/her legal representative for participation in the study.

You may not qualify if:

  • Active tumor disease.
  • Pregnancy.
  • Participation in another active clinical trial.
  • Any circumstance that in the researcher's opinion justifies the patient's non-participation in the trial.
  • Not consent to participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Rio Hortega

Valladolid, 47012, Spain

Location

Related Publications (4)

  • Vega A, Martin-Ferrero MA, Del Canto F, Alberca M, Garcia V, Munar A, Orozco L, Soler R, Fuertes JJ, Huguet M, Sanchez A, Garcia-Sancho J. Treatment of Knee Osteoarthritis With Allogeneic Bone Marrow Mesenchymal Stem Cells: A Randomized Controlled Trial. Transplantation. 2015 Aug;99(8):1681-90. doi: 10.1097/TP.0000000000000678.

    PMID: 25822648BACKGROUND

  • Noriega DC, Ardura F, Hernandez-Ramajo R, Martin-Ferrero MA, Sanchez-Lite I, Toribio B, Alberca M, Garcia V, Moraleda JM, Sanchez A, Garcia-Sancho J. Intervertebral Disc Repair by Allogeneic Mesenchymal Bone Marrow Cells: A Randomized Controlled Trial. Transplantation. 2017 Aug;101(8):1945-1951. doi: 10.1097/TP.0000000000001484.

    PMID: 27661661BACKGROUND

  • Barbado J, Tabera S, Sanchez A, Garcia-Sancho J. Therapeutic potential of allogeneic mesenchymal stromal cells transplantation for lupus nephritis. Lupus. 2018 Nov;27(13):2161-2165. doi: 10.1177/0961203318804922. Epub 2018 Oct 5.

    PMID: 30290717BACKGROUND

  • Leng Z, Zhu R, Hou W, Feng Y, Yang Y, Han Q, Shan G, Meng F, Du D, Wang S, Fan J, Wang W, Deng L, Shi H, Li H, Hu Z, Zhang F, Gao J, Liu H, Li X, Zhao Y, Yin K, He X, Gao Z, Wang Y, Yang B, Jin R, Stambler I, Lim LW, Su H, Moskalev A, Cano A, Chakrabarti S, Min KJ, Ellison-Hughes G, Caruso C, Jin K, Zhao RC. Transplantation of ACE2- Mesenchymal Stem Cells Improves the Outcome of Patients with COVID-19 Pneumonia. Aging Dis. 2020 Mar 9;11(2):216-228. doi: 10.14336/AD.2020.0228. eCollection 2020 Apr.

    PMID: 32257537BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Genes, mosSodium Chloride

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Proto-OncogenesOncogenesGenes, NeoplasmGenesGenome ComponentsGenomeGenetic StructuresGenetic PhenomenaChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Julia Barbado, MD, PhD

    University Hospital Río Hortega, Valladolid, Spain

    STUDY CHAIR

  • Rosa Conde, PhD

    University Hospital Río Hortega, Valladolid, Spain

    STUDY DIRECTOR

  • Margarita González-Vallinas, PhD

    University of Valladolid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Both experimental and placebo groups will receive a similar endovenous injection with either cells or placebo, respectively. Blind to participant, investigator and care providers.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2020

First Posted

April 24, 2020

Study Start

May 1, 2020

Primary Completion

October 28, 2021

Study Completion

October 28, 2021

Last Updated

February 2, 2024

Record last verified: 2024-01

Locations

ES(1)