A trial conducted under a compassionate program for COVID-19 patients
Latest Information Update: 04 Apr 2023
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 Pluri
- 13 Mar 2023 According to a Pluristem Therapeutics media release, Pluristem Therapeutics has changed its name to Pluri Inc.
- 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.
Most Recent Events
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 |
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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 Pluri
- Affiliations Pluri
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 |
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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
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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 -
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
Trial Centres
Centres
Centre Name | Location | Trial Centre Country |
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Pluri |
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Pluristem Therapeutics |
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Trial History
Event Date | Event Type | Comment |
---|---|---|
13 Mar 2023 | Other trial event | According to a Pluristem Therapeutics media release, Pluristem Therapeutics has changed its name to Pluri Inc. Updated 04 Apr 2023 |
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
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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 -
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 -
Pluristem Therapeutics. Pluristem Treated First Three COVID-19 Patients in Israel under Compassionate Use. Media-Rel 2020;.
Media Release -
Pluristem Therapeutics. Pluristem Therapeutics Inc. Changes its Name to ##8220##Pluri Inc.##8221## Reflecting the Company's Strategy to Leverage its Innovative 3D Cell-based Technology Platform to Additional Industries. Media-Rel 2023;.
Media Release
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