Treatment of Coronavirus COVID-19 Pneumonia (Pathogen SARS-CoV-2) With Cryopreserved Allogeneic P_MMSCs and UC-MMSCs

NCT04461925 | Unknown Phase 1 DMC

• 1 other identifier: #4/24.04.2020
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Assessment of the clinical effects of infusions of cryopreserved allogeneic multipotent mesenchymal stem cells of the placenta and umbilical cord for COVID-19 patients with acute respiratory distress syndrome.

Conditions

COVID-19 Pneumonia

Keywords

Placenta-derived MMSCs; i/v infusions

Outcome Measures

Primary Outcomes (3)

• Changes of oxygenation index PaO2/FiO2, most conveniently the P/F ratio.

  Improvement of pulmonary function. Arterial oxygen tension PaO2 (in mmHg)/fractional inspired oxygen FiO2 (expressed as a fraction, not a percentage), most conveniently the P/F ratio. The normal P/F ratio is \~ 400-500 mmHg (\~55-65 kPa). P/F ratio \<300mmHg - sign of Acute Respiratory Distress Syndrome (ARDS)

  up to 28 days

• Changes in length of hospital stay

  Length of Hospital Stay

  up to 28 days

• Changes in mortality rate

  Marker for efficacy of treatment

  up to 28 days

Secondary Outcomes (4)

• Changes of С-reactive protein (CRP, mg/L)

  At baseline, Day 1, Week 1, Week 2, Week 4, Week 8

• Evaluation of Pneumonia Improvement

  At baseline, Day 1, Week 1, Week 2, Week 4, Week 8

• Duration of respiratory symptoms (difficulty breathing, dry cough, fever, etc.)

  At baseline, Day 1, Week 1, Week 2, Week 4, Week 8

• Peripheral blood count recovery time

  At baseline, Day 1, Week 1, Week 2, Week 4, Week 8

Study Arms (2)

Experimental group

EXPERIMENTAL

On the basis conventional symptomatic treatment and supportive therapy, P-MMSCs were given at 1 million cells/kg body weight/ time, once every 3 days for a total of 3 times: Day "1", Day "4", Day "7".

Procedure: Placenta-Derived MMSCs; Cryopreserved Placenta-Derived Multipotent Mesenchymal Stromal Cells; Drug: Antibiotics; Drug: Hormones; Drug: Anticoagulant Therapy; Device: Оxygen therapy

Control Group

ACTIVE COMPARATOR

Conventional symptomatic treatments such as antibacterial (ceftriaxone, azithromycin), anticoagulants, hormones, oxygen therapy, mechanical ventilation and other supportive therapies

Drug: Antibiotics; Drug: Hormones; Drug: Anticoagulant Therapy; Device: Оxygen therapy

Interventions

Placenta-Derived MMSCs; Cryopreserved Placenta-Derived Multipotent Mesenchymal Stromal Cells PROCEDURE

i/v infusions

Also known as: P-MMSCs

Experimental group

Antibiotics DRUG

per os

Also known as: ceftriaxone and azithromycin capsules

Control Group; Experimental group

Hormones DRUG

a moderate amount of dexamethasone i/v

Also known as: dexamethasone

Control Group; Experimental group

Anticoagulant Therapy DRUG

Sub-Q

Also known as: Еnoxaparin

Control Group; Experimental group

Оxygen therapy DEVICE

Оxygen therapy, mechanical ventilation and other supportive therapies

Also known as: Оxygen insufflation

Control Group; Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged at 18 years (including) - 75 years old.
• Laboratory confirmation of SARS-CoV-2 infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source.
• Pneumonia that is judged by X-ray imaging.
• In accordance with any one of the following:
• dyspnea (RR ≥ 30 times / min);
• finger oxygen saturation ≤ 93% in resting state;
• arterial oxygen partial pressure (PaO2) / oxygen absorption concentration (FiO2) ≤ 300MMHG (if possible);
• invasive ventilation\< 48 h.

You may not qualify if:

• Male or female, aged at \<18 years and \> 75 years old.
• 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, syphilis.
• Invasive ventilation \> 48 h.
• Combined with other organ failure (need organ support).

Sponsors & Collaborators

• Institute of Cell Therapy: lead
• Kyiv City Clinical Hospital # 4: collaborator

Study Sites (1)

Institute of Cell Therapy

Kyiv, 04073, Ukraine

RECRUITING

MeSH Terms

Interventions

Anti-Bacterial Agents; Ceftriaxone; Azithromycin; Hormones; Dexamethasone

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Peter Nemtinov, MD

  Institute of Cell Therapy

  STUDY DIRECTOR

Central Study Contacts

Peter Nemtinov, MD

CONTACT

+380442079207; nemtinov@stemcellclinic.com

Alina Ustymenko, PhD

CONTACT

+380442079207; ustimenko@stemcellclinic.com

Study Design

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

Model Details: Experimental: stem cells therapy + treatment in according with approved by Ukrainian Health Ministry COVID-19 clinical protocol Experimental Group 1: Subjects with severe COVID-19 pneumonia shall be received three infusions of cryopreserved allogeneic P-MMSCs (1 million cells/kg body weight) at 2-days intervals: Day "1", Day "4", Day "7". Control Group: treatment in according with approved by Ukrainian MoH COVID-19 clinical protocol.

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 8, 2020
• Study Start: May 2, 2020
• Primary Completion: May 2, 2021
• Study Completion: December 1, 2021
• Last Updated: July 8, 2020

Record last verified: 2020-06

Locations

UA (1)