NCT04713878

Brief Summary

Due to the cytokine storm that develops as a result of Coronavirus Disease 2019 (COVID-19) infection, some patients hospitalization to intensive care cause of pneumonia, Acute Respiratory Distress Syndrome (ARDS) and multiple organ failure. Mortality is higher in treatment-resistant cases. Purpose of this study:

  1. 1.Providing immune modulation by Stem Cell Transplantation and reducing the damage caused by cytokine storm to tissues and organs,
  2. 2.Correcting immunosuppression and fight against COVID-19 virus by editing B and T cells,
  3. 3.It is to accelerate healing in organ damage by increasing growth factors through mesenchymal stem cells.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

May 8, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 19, 2021

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

January 9, 2021

Last Update Submit

January 16, 2021

Conditions

Coronavirus Disease 2019 (COVID-19) Pneumonia

Keywords

Mesenchymal stem cellsCOVID-19Pneumonia

Outcome Measures

Primary Outcomes (4)

  • Change of clinical symptoms as respiratory distress or need for oxygen support

    Recovery of patient from mechanical and oxygen support

    3 months

  • Change of cytokine storm parameters

    respiratory rates \< 30 times /min

    3 months

  • Change of pulmonary functions

    Oxygen saturation \> 93% and pulmonary imaging of focus within 24-48 hours \> 50% progression

    3 months

  • Change of clinical symptoms

    arterial pressure of oxygen/the fraction of inspired oxygen\>300mmHg

    3 months

Study Arms (3)

Group 1

ACTIVE COMPARATOR

Intubated without comorbidity

Other: Mesenchymal stem cells

Group 2

ACTIVE COMPARATOR

Intubated with comorbidity

Other: Mesenchymal stem cells

Group 3

ACTIVE COMPARATOR

No intubated

Other: Mesenchymal stem cells

Interventions

Mesenchymal stem cellsOTHER

Intravenous infusion of Mesenchymal stem cells

Group 1Group 2Group 3

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 18-90 male or female
  • laboratory approve of RT-PCR (real-time reverse transcription polymerase chain reaction) with COVID-19 infection
  • pneumonia assessed by chest radiography or computed tomography
  • In accordance with any of the following: 1)Respiratory rate ≥ 30 times / min 2) oxygen saturation ≤ 93% 3) arterial pressure of oxygen/the fraction of inspired oxygen≤ 300mmHg, 4) pulmonary imaging of focus within 24-48 hours \> 50% progression
  • patients who remain unresponsive to medications administered according to Ministry of health guidelines
  • Patients who receiving invasive or non-invasive mechanical ventilation therapy in intensive care

You may not qualify if:

  • Pregnancy
  • Any kind of cancer, severe liver disease
  • Failure to provide informed consent or comply with test requirements
  • Known allergy or hypersensitivity to MSCs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19Pneumonia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ebru Kaya, MD

    Kanuni Sultan Suleyman Education and Training Hospital

    STUDY CHAIR

  • Gursel Turgut, Prof Dr

    Genkord

    STUDY CHAIR

  • Ali Kocatas, MD

    Kanuni Sultan Suleyman Education and Training Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Coronavirus Disease 2019 (COVID-19) patients with pneumonia 1.group: Intubated without comorbidity, 2.group: Intubated with comorbidity, 3.group: No intubated
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof

Study Record Dates

First Submitted

January 9, 2021

First Posted

January 19, 2021

Study Start

May 8, 2020

Primary Completion

June 30, 2020

Study Completion

July 15, 2020

Last Updated

January 20, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)