NCT04382547

Brief Summary

Treatment of patients with Covid-19 associated pneumonia using intravenous injection of allogenic pooled olfactory mucosa-derived mesenchymal stem cells

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2020

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

May 8, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 11, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

May 11, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

August 23, 2021

Status Verified

August 1, 2021

Enrollment Period

1.1 years

First QC Date

May 8, 2020

Last Update Submit

August 20, 2021

Conditions

COVIDCovid-19CoronavirusPneumoniaPneumonia, ViralPneumonia, InterstitialSars-CoV2

Keywords

pneumoniaSars-COV2Covid-19

Outcome Measures

Primary Outcomes (1)

  • Number of cured patients

    Number of patients cured, assessed by PCR in addition to chest CT scan

    3 weeks

Secondary Outcomes (1)

  • Number of patients with treatment-related adverse events

    3 weeks

Study Arms (2)

mesenchymal stem cells

EXPERIMENTAL

Patients with Covid-19 associated pneumonia receiving standard treatment and allogenic pooled olfactory mucosa-derived mesenchymal stem cells

Biological: Allogenic pooled olfactory mucosa-derived mesenchymal stem cellsOther: Standard treatment according to the Clinical protocols

control

ACTIVE COMPARATOR

Patients with Covid-19 associated pneumonia receiving standard treatment

Other: Standard treatment according to the Clinical protocols

Interventions

Allogenic pooled olfactory mucosa-derived mesenchymal stem cellsBIOLOGICAL

Allogenic pooled olfactory mucosa-derived mesenchymal stem cells

mesenchymal stem cells
Standard treatment according to the Clinical protocolsOTHER

Standard treatment according to the Clinical protocols

controlmesenchymal stem cells

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PCR-confirmed Covid-19 pneumonia
  • respiratory failure

You may not qualify if:

  • diagnosed cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Minsk, 220072, Belarus

Location

MeSH Terms

Conditions

COVID-19Coronavirus InfectionsPneumoniaPneumonia, ViralLung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Andrei Y Hancharou, Dr.

    Director, the Institute of Biophysics and Cell Engineering of NAS of Belarus

    STUDY DIRECTOR

  • Eduard A Dotsenko, Dr., prof.

    Head of the chair, Belarusian State Medical University

    STUDY DIRECTOR

  • Natalia G Antonevich, Dr.

    Head of the Lab of Institute of Biophysics and Cell Engineering of NAS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2020

First Posted

May 11, 2020

Study Start

May 11, 2020

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

August 23, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)