Allogeneic Mesenchymal Stromal Cell (MSC) Therapy for SARS-CoV-2 Pneumonia: A Prospective Randomized Multicentre Phase I/IIa Open Label Study - RESCAT

Overview

No summary available.

Registry

who.int

Start Date

October 21, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Adult patients suffering from SARS\-CoV\-2 induced severe pneumonia admitted to semi\-intensive or intensive COVID Units because of the need of ventilation support.
•Sign of the informed consent,
•Patients of either sex, aged 18\-80 years (inclusive),
•Patient with a confirmed virological diagnosis of SARS\-CoV2 infection by means of real\-time Polymerase Chain Reaction,
•Hospitalization due to clinical and radiological diagnosis of pneumonia,
•PaO2/FiO2 value between 150\-300 with impending necessity of noninvasive positive pressure respiratory support (nCPAP) or ventilator support through nasal pressure support ventilation (nPSV),
•Systolic artery pressure \>90 mmHg without amine support,
•Modified Early Warning Score (MEWS) score \<3,
•Absence of known active malignancy.
•Are the trial subjects under 18? no

•Deny to informed consent,
•Known history of alcohol or drug abuse in the 12 months prior to inclusion,
•Presence of significant comorbidities, such as uncontrolled hypertension, invalidating psychiatric or neurological disorders, organ failure (renal impairment defined by creatinine clearance below 50 ml/min or by serum creatinine \=2\.0 mg/dl; hepatic impairment defined by total bilirubin \=2\.0 mg/dl and AST \+ ALT \= 2\.5 x upper normal value; cardiac failure with an output fraction \=40%), or any other clinically significant condition, as determined by the Principal Investigator,
•Presence of chronic advanced cardio\-pulmonary diseases, such as ILDs (obstructive pneumonia, severe pulmonary interstitial fibrosis, alveolar proteinosis, allergic alveolitis),
•Patient has a clinically relevant abnormality on electrocardiogram, as determined by the Principal Investigator,
•History of previous embolism,
•Known active malignancy,
•Patient with a history of severe allergic reactions (e.g., swelling of the mouth and throat, difficulty breathing, hypotension, or shock) requiring medical intervention,
•Patient with a positive test for human immunodeficiency virus or active hepatitis B or C disease or tuberculosis or further viral infections (influenza virus, adenovirus and other respiratory viruses),
•Patient is known to be pregnant, has a positive pregnancy test or is nursing,