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A trial conducted under a compassionate program for COVID-19 patients

Trial Profile

A trial conducted under a compassionate program for COVID-19 patients

Status: Recruiting
Phase of Trial: Clinical Phase Unknown

Latest Information Update: 14 May 2020

At a glance

  • Drugs COVID-19 infection therapeutics Charite University of Medicine Berlin/Pluristem Therapeutics (Primary)
  • Indications COVID 2019 infections
  • Focus Expanded access; Therapeutic Use
  • Sponsors Pluristem Therapeutics
  • Most Recent Events

    • 14 May 2020 According to a Pluristem Therapeutics media release, 7 patients have completed a 28-day follow up period.
    • 14 May 2020 Results presented in the Pluristem Therapeutics Media Release.
    • 08 Apr 2020 New trial record

Trial Overview

Purpose

This study is conducted under a compassionate program for COVID-19 patients.

Other Endpoints

Survival rate, respiratory parameters, weaning from ventilators, multi-organ failure. [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Sex male & female
  • Age Group adult

Patient Inclusion Criteria

Patients suffering from acute respiratory failure and inflammatory complications associated with COVID-19.

Trial Details

Organisations

  • Sponsors Pluristem Therapeutics
  • Affiliations Pluristem Therapeutics

Trial Dates

Other Details

  • Design multicentre; prospective
  • Phase of Trial Clinical Phase Unknown
  • Location Israel
  • Focus Expanded access; Therapeutic Use

Interventions

Drugs Route Formulation
COVID-19 infection therapeutics Charite University of Medicine Berlin/Pluristem TherapeuticsPrimary Drug Parenteral
-

COVID-19 infection therapeutics

Results

Therapeutic efficacy

Preliminary data from PLX cell against COVID-19 infections reported 87.5% survival rate in eight patients in the 28 day follow up. Improvement in respiratory parameters was observed in 4 out of 6 patients and 75% patients survived without assistance of ventilators. In addition, 62.5% patients were discharged alive from the hospital in comparison to 3.3% patients requiring mechanical ventilation. One patient has shown no change in respiratory parameters, is still breathing with the assistance of a ventilator and remains relatively stable. Deterioration in respiratory parameters was observed in one patient. Two patients out of four with multi-organ failure prior to treatment, showed clinical recovery in addition to the respiratory improvement [2] [1]

Publications

  1. Pluristem Therapeutics. Pluristem Reports Preliminary Data from its COVID-19 Compassionate Use Program, Treating Seven Patients with Acute Respiratory Failure. Media-Rel 2020;.

    Media Release
  2. Pluristem Therapeutics. Pluristem Provides 28-Day Follow Up for Ventilator-Dependent COVID-19 Patients under Compassionate Use Program in Israel and U.S. Media-Rel 2020;.

    Media Release

Authors

Author Total Publications First Author Last Author
Pluristem Therapeutics 2 2 2

Trial Centres

Centres

Centre Name Location Trial Centre Country
Pluristem Therapeutics
-
-

Trial History

Event Date Event Type Comment
14 May 2020 Other trial event According to a Pluristem Therapeutics media release, 7 patients have completed a 28-day follow up period. Updated 19 May 2020
14 May 2020 Results Results presented in the Pluristem Therapeutics Media Release. Updated 19 May 2020
08 Apr 2020 New trial record New trial record Updated 08 Apr 2020
07 Apr 2020 Interim results Preliminary (n=7) results presented in the Pluristem Therapeutics Media Release. Updated 04 May 2020
30 Mar 2020 Other trial event According to a Pluristem Therapeutics media release, as of now three patients have been treated under this compassionate program, as approved by the Israeli Ministry of Health. Pluristem expects to enroll additional patients in Israel in the coming days and anticipates providing updates on clinical outcomes once significant data has been gathered. Updated 08 Apr 2020

References

  1. Pluristem Therapeutics. Pluristem Reports Preliminary Data from its COVID-19 Compassionate Use Program, Treating Seven Patients with Acute Respiratory Failure. Media-Rel 2020;.

    Media Release
  2. Pluristem Therapeutics. Pluristem Provides 28-Day Follow Up for Ventilator-Dependent COVID-19 Patients under Compassionate Use Program in Israel and U.S. Media-Rel 2020;.

    Media Release
  3. Pluristem Therapeutics. Pluristem Treated First Three COVID-19 Patients in Israel under Compassionate Use. Media-Rel 2020;.

    Media Release
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