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Pneumonia, ViralPhase 2NCT04269525

Umbilical Cord(UC)-Derived Mesenchymal Stem Cells(MSCs) Treatment for the 2019-novel Coronavirus(nCOV) Pneumonia

A Phase 2 study testing UC-MSCs in people with Pneumonia, Viral and Pneumonia, Ventilator-Associated, run by ZhiYong Peng at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Serious Pneumonia and Critical Pneumonia caused by the 2019-nCOV infection greatly threats patients' life, UC-MSCs treatment has been proved to play a role in curing multiple diseases. And this study is conducted to find out whether or not it will function in 2019-nCOV infection Pneumonia. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
UC-MSCs
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteChina
Study dates
6 Feb 2020to 30 Dec 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-80 years old ,no gender restriction
  • According to Diagnosis and Clinical Management of Pneumonia caused by 2019-nCoV infection(Trial Version 6), patients are diagnosed with severe or critical 2019-nCoV pneumonia
  • Women of childbearing age should have a negative blood pregnancy test before the start of dosing and agree to take effective contraceptive measures during the trial until the last follow-up (28 days)
  • Previous detection of Nucleotide or antibody of 2019-nCoV pneumonia was positive
  • Voluntarily participate in this clinical study and sign a written informed consent. If the patient cannot obtain informed consent, he can authorize his legal representative.

Who cannot join

  • Liver SOFA score of more than 3 points;
  • HIV positive
  • Highly allergic constitution or history of severe allergies;
  • Pregnant and lactating women;
  • Patients with malignant tumors;
  • Patients with previous history of pulmonary embolism;
  • Participating in clinical trials of other drugs within 3 months before enrollment.
  • be thought by researchers to be inappropriate to participate in this clinical study.

Trial locations and contacts

1 site in 1 country.

XingHuan Wang, professor contact

18971387168

znyylcsy@126.com

ZhiYong Peng, professor contact

18672396028

pengzy5@hotmail.com

China1 site, 1 recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430000

    XingHuan Wang, professor

    ZhiYong Peng, professor

    Recruiting

Other trials in China

About this study

Official title: Clinical Research Regarding the Availability and Safety of UC-MSCs Treatment for Serious Pneumonia and Critical Pneumonia Caused by the 2019-nCOV Infection

Serious Pneumonia and Critical Pneumonia caused by the 2019-nCOV infection greatly threats patients' life, UC-MSCs treatment has been proved to play a role in curing multiple diseases. And this study is conducted to find out whether or not it will function in 2019-nCOV infection Pneumonia.

Read the detailed description

Serious Pneumonia and Critical Pneumonia caused by the 2019-nCOV infection greatly threats patients' life, UC-MSCs treatment has been proved to play a role in curing multiple diseases. And this study is conducted to find out whether or not it will function in 2019-nCOV infection Pneumonia. And we are going to get the permission of the enrolled patients. Besides the present clinical treatment, UC-MSCs treatment will be applied to those fulfilling the enrollment. After a period of UC-MSCs treatment, the analysis of UC-MSCs treatment will be completed from related aspects.

Being tested
UC-MSCs
Keywords
2019-nCOV infection, UC-MSCs Treatment
Medical subject headings
Pneumonia, Viral, Pneumonia, Ventilator-Associated, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UC-MSCsBiological

    After enrollment, each subject will receive UC-MSCs infusion intravenously on day 1, day 3, day 5, and day 7.

Study groups in NCT04269525
Study groupRoleWhat they receive
pneumoniaExperimentalAccording to Diagnosis and Clinical Management of Pneumonia caused by 2019-nCoV Infection(Trial Version 4), patients enrolled will be divided to serious pneumonia group or critical pneumonia group. All subjects will receive UC-MSCs 3.3 * 107 cell number / 50ml / bag, 3 bags each time. And UC-MSCs will be infused intravenously on the 1st, 3rd, 5th, and 7th days after enrollment, 1 time each day. The efficacy and safety of the treatment, patients' adverse reactions will be monitored.
Receives: Biological: UC-MSCs

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oxygenation index

    partial arterial oxygen pressure (PaO2) / oxygen concentration (FiO2)

    Measured: on the day 14 after enrollment

Secondary outcomes (18)

  1. 28 day mortality

    whether the patient survives

    Measured: on the day 28 after enrollment

  2. Hospital stay

    days of the patients in hospital

    Measured: up to 6 months

  3. 2019-nCoV antibody test

    whether or not the 2019-nCoV antibody is positive

    Measured: on the day 7,14,28 after enrollment

  4. 2019-nCoV nucleic acid test

    whether or not the 2019-nCoV nucleic acid test is positive

    Measured: on the day 7,14,28 after enrollment

  5. Improvement of lung imaging examinations

    whether lung imaging examinations show the improvement of the pneumonia

    Measured: on the day 7,14,28 after enrollment

  6. White blood cell count

    counts of white blood cell in a litre of blood

    Measured: on the day 7,14,28 after enrollment

  7. Lymphocyte count

    counts of lymphocyte in a litre (L) of blood

    Measured: on the day 7,14,28 after enrollment

  8. Procalcitonin

    procalcitonin in microgram(ug)/L

    Measured: on the day 7,14,28 after enrollment

  9. interleukin(IL)-2

    IL-2 in picogram(pg)/millilitre(mL)

    Measured: on the day 7,14,28 after enrollment

  10. IL-4

    IL-4 in pg/mL

    Measured: on the day 7,14,28 after enrollment

  11. IL-6

    IL-6 in pg/mL

    Measured: on the day 7,14,28 after enrollment

  12. IL-10

    IL-10 in pg/mL

    Measured: on the day 7,14,28 after enrollment

  13. tumor necrosis factor(TNF)-α

    TNF-α in nanogram(ng)/L

    Measured: on the day 7,14,28 after enrollment

  14. γ-interferon(IFN)

    γ-IFN in a thousand unit (KU)/L

    Measured: on the day 7,14,28 after enrollment

  15. C-reactive protein(CRP)

    CRP in microgram（μg）/L

    Measured: on the day 7,14,28 after enrollment

  16. CD4+ T-Lymphocytopenia

    counts of CD4+ T-Lymphocytopenia in litre

    Measured: on the day 7,14,28 after enrollment

  17. CD8+ T-Lymphocytopenia

    counts of CD8+ T-Lymphocytopenia in a litre

    Measured: on the day 7,14,28 after enrollment

  18. natural killer cell(NK)

    counts of NK in a litre

    Measured: on the day 7,14,28 after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2020
  2. Study start6 Feb 2020
  3. Primary completion1 Dec 2020 (estimated)
  4. Study completion30 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
reaching the criteria of pneumonia according to Diagnosis and Clinical Management of Pneumonia caused by 2019-nCoV Infection(Trial Version 4)
Masking
None (open label)
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04269525
Sponsor's protocol ID
2020002
Status last verified
Jun 2020
First submitted
7 Feb 2020
Last updated
1 Jul 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing UC-MSCs in people with Pneumonia, Viral and Pneumonia, Ventilator-Associated, run by ZhiYong Peng at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact XingHuan Wang, professor (18971387168, znyylcsy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oxygenation index (time frame: on the day 14 after enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04269525.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2020.

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