Clinical study on mesenchymal Cell Therapy for SARS-CoV-2 Pneumonia

Phase 1

• Conditions: SARS-CoV-2 pneumonia; MedDRA version: 22.1Level: LLTClassification code 10061229Term: Lung infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-001577-70-IT
• Lead Sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-21
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

• 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,
• Patient has had major surgery, either open or laparoscopic, within the 3 months prior to screening,
• Previous haematopoietic stem cell or organ transplantation,
• Patient under immunosuppressive agents,
• Patients currently receiving, or having received within 2 months prior to enrolment into this clinical study, any other investigational drug.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified