NCT04252118

Brief Summary

The SARS-CoV-2 infection caused clusters of severe respiratory illness similar to severe acute respiratory syndrome coronavirus and was associated with ICU admission and high mortality. There is no confirmed antivirus therapy for people infected SARS-CoV-2, most of them should receive supportive care to help relieve symptoms. For severe cases, treatment should include care to support vital organ functions. This clinical trial is to inspect the safety and efficiency of Mesenchymal Stem Cells (MSCs) therapy for pneumonia patients infected with SARS-CoV-2.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_1 covid19

Timeline
Completed

Started Jan 2020

Longer than P75 for phase_1 covid19

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

January 27, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

January 27, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

April 15, 2020

Status Verified

April 1, 2020

Enrollment Period

10 months

First QC Date

January 27, 2020

Last Update Submit

April 13, 2020

Conditions

COVID-19

Keywords

COVID-19SafetyEfficiencyCell TherapyMesenchymal stem cell

Outcome Measures

Primary Outcomes (2)

  • Size of lesion area by chest radiograph or CT

    Evaluation of Pneumonia Improvement

    At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21，Day 28

  • Side effects in the MSCs treatment group

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180

Secondary Outcomes (7)

  • Improvement of Clinical symptoms including duration of fever and respiratory

    At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28

  • Time of nucleic acid turning negative

    At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180

  • Rate of mortality within 28-days

    Day 28

  • CD4+ and CD8+ T celll count

    At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180

  • Alanine aminotransferase

    At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180

  • +2 more secondary outcomes

Study Arms (2)

MSCs Treatment Group

EXPERIMENTAL

Conventional treatment plus MSCs Participants will receive conventional treatment plus 3 times of MSCs(3.0\*10E7 MSCs intravenously at Day 0, Day 3, Day 6).

Biological: MSCs

Conventional Control Group

NO INTERVENTION

Without MSCs Therapy but conventional treatment should be received.

Interventions

MSCsBIOLOGICAL

3 times of MSCs(3.0\*10E7 MSCs intravenously at Day 0, Day 3, Day 6).

MSCs Treatment Group

Eligibility Criteria

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

You may qualify if:

  • Male or female, aged at 18 years (including) -70 years old
  • Confirmed COVID-19 by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source; and
  • Pneumonia that is judged by chest radiograph or computed tomography.

You may not qualify if:

  • Pregnancy, lactation and those who are not pregnant but do not take effective contraceptives measures;
  • Patients with malignant tumor, other serious systemic diseases and psychosis;
  • Patients who are participating in other clinical trials;
  • Inability to provide informed consent or to comply with test requirements.
  • Co-Infection of HIV, tuberculosis, influenza virus, adenovirus and other respiratory infection virus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing 302 Military Hospital of China

Beijing, 100039, China

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Lei Shi, MD,PhD

CONTACT

86-10-66933333shilei302@126.com

Fusheng Wang, MD,PhD

CONTACT

86-10-66933328fswang302@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Treatment and Research Center for Infectious Diseases, Principle Investigator, Clinical Professor

Study Record Dates

First Submitted

January 27, 2020

First Posted

February 5, 2020

Study Start

January 27, 2020

Primary Completion

December 1, 2020

Study Completion

December 1, 2021

Last Updated

April 15, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)