Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04614025
Other study ID # PLX-COV-03
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date October 19, 2020
Est. completion date February 7, 2023

Study information

Verified date October 2023
Source Pluristem Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This clinical trial will examine if a new treatment of Mesenchymal-like Adherent stromal Cells (called PLX-PAD) can help patients intubated and mechanically ventilated due to COVID-19 to recover more quickly with less complications.


Recruitment information / eligibility

Status Terminated
Enrollment 23
Est. completion date February 7, 2023
Est. primary completion date August 4, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Key Inclusion Criteria: - Willing and able to provide written informed consent, or with a legal representative who can provide informed consent. - Male or non-pregnant female adult 18-85 years of age at time of enrollment. - Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, in any specimen up to 21 days prior to randomization. - Meets definition of ARDS according to Berlin criteria. Key Exclusion Criteria: - Body weight under 55 kg (121 lbs) - Serum creatinine level of over 1.5 mg/dL at time of randomization. - Total Bilirubin =2 mg/dL at time of randomization. - Known allergy to any of the following: dimethyl sulfoxide (DMSO), human serum albumin, bovine serum albumin. - Stroke or acute myocardial infarction/unstable angina within 3 months prior to randomization. - Chronic Obstructive Pulmonary disease GOLD stage above II.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
PLX-PAD
PLX-PAD - allogeneic ex-vivo expanded placental mesenchymal-like adherent stromal cells

Locations

Country Name City State
Germany Campus Benjamin Franklin - CBF Charité - Universitätsmedizin Berlin
Germany Charite Campus Virchow Berlin
Germany University of hospital Bonn Bonn
Germany Hospital Cologne-Merheim Köln
Israel Emek Medical Center Afula
Israel Bnai Zion Medical Center Haifa
Israel Rambam Health Care Campus Haifa
Israel Galilee Medical Center Nahariya
Israel Baruch Padeh Medical Center, Poriya Tiberias

Sponsors (1)

Lead Sponsor Collaborator
Pluristem Ltd.

Countries where clinical trial is conducted

Germany,  Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of ventilator-free days 28 days
Secondary All-cause mortality 28 and 60 days
Secondary Duration of mechanical ventilation 28 and 60 days
See also
  Status Clinical Trial Phase
Terminated NCT04558125 - Low-Dose Tenecteplase in Covid-19 Diagnosed With Pulmonary Embolism Phase 4
Recruiting NCT04410510 - P2Et Extract in the Symptomatic Treatment of Subjects With COVID-19 Phase 2/Phase 3
Active, not recruiting NCT04420676 - Synbiotic Therapy of Gastrointestinal Symptoms During Covid-19 Infection N/A
Completed NCT04419025 - Efficacy of N-Acetylcysteine (NAC) in Preventing COVID-19 From Progressing to Severe Disease Phase 2
Completed NCT04395911 - Safety and Efficacy of SCD in AKI or ARDS Patients Associated With COVID-19 Infections N/A
Completed NCT04425317 - Detection of SARS-CoV-2 in Follicular Fluid and Cumulus-oocyte-complexes in COVID-19 Patients N/A
Withdrawn NCT04456426 - Characteristics of Patients With COVID-19 in Meta State, Colombia
Completed NCT04526769 - Detecting SARS-CoV-2 in Tears
Suspended NCT04385771 - Cytokine Adsorption in Patients With Severe COVID-19 Pneumonia Requiring Extracorporeal Membrane Oxygenation N/A
Completed NCT04425720 - Use of Remote Monitoring for COVID-19 Patient N/A
Completed NCT04419610 - RAS and Coagulopathy in COVID19 Early Phase 1
Completed NCT04546581 - Inpatient Treatment of COVID-19 With Anti-Coronavirus Immunoglobulin (ITAC) Phase 3
Completed NCT04435327 - Lung Damage Caused by SARS-CoV-2 Pneumonia (COVID-19)
Terminated NCT04530448 - Coronavirus Induced Acute Kidney Injury: Prevention Using Urine Alkalinization Phase 4
Not yet recruiting NCT04524156 - COVID-19 : Transcutaneous pO2 and pCO2 as Predictive Factors for Acute Respiratory Destress Syndrome in Patients Affected With SARS-Cov-2 N/A
Completed NCT04441710 - Caregiver Serological Monitoring Extended Secondarily to Patients With the SARS-CoV-2 Coronavirus
Completed NCT04357834 - WAVE. Wearable-based COVID-19 Markers for Prediction of Clinical Trajectories
Not yet recruiting NCT04392427 - New Antiviral Drugs for Treatment of COVID-19 Phase 3
Completed NCT04402957 - LSALT Peptide vs. Placebo to Prevent ARDS and Acute Kidney Injury in Patients Infected With SARS-CoV-2 (COVID-19) Phase 2
Recruiting NCT04397705 - Remote Monitoring of Cancer Patients With Suspected Covid-19 Phase 1

External Links