Status:
COMPLETED
Study Evaluating the Safety and Efficacy of Autologous Non-Hematopoietic Peripheral Blood Stem Cells in COVID-19
Lead Sponsor:
Abu Dhabi Stem Cells Center
Conditions:
Coronavirus Disease 2019 (COVID-19)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
SENTAD-COVID Study is an adaptive, prospective, multicentric, open-label, and randomized controlled clinical trial involving hospitalized adult patients with confirmed coronavirus disease 2019 (COVID-...
Detailed Description
Group A patients received autologous NHPBSC therapy through jet nebulization, in addition to the standard care, while Group B (No investigational intervention arm) received only the UAE approved stand...
Eligibility Criteria
Inclusion
- RT-PCR Laboratory confirmation of COVID-19.
- Male or female aged ≥ 18 years.
- Interstitial lung change ≥ 3 judged by "Lungs Lobar based scoring" according to computed tomography (CT) scans.
- Hospitalized and symptomatic patients, referring one or more of the following symptoms (fever, cough, or shortness of breath), in association with (at least one): tiredness, runny nose, headache, sore throat, chills, muscle pain, or new loss of taste or smell).
- Ability to comply with test requirements and peripheral blood stem cells collection.
- The patient or legal representative agrees to participate in the study, and signs the SENTAD-COVID Study informed consent form.
Exclusion
- Pediatric patients (aged \< 18 years).
- Diagnosis of any kind of shock.
- Organ transplants in the past 3 months.
- Patients receiving immunosuppressive therapy.
- Diagnostic of Hepatitis B Virus (HBV) infection.
- Diagnostic of Human Immunodeficiency Virus (HIV) infection or Acquired Immunodeficiency Syndrome (AIDS).
- Current diagnosis of cancer.
- History of malignancies in the past 5 years.
- Pregnant or lactating women.
- Have participated in other clinical trials in the past 3 months.
- Inability to comply with test requirements and peripheral blood stem cells collection.
- Inability to provide informed consent.
Key Trial Info
Start Date :
April 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 14 2020
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT04473170
Start Date
April 4 2020
End Date
July 14 2020
Last Update
July 16 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Abu Dhabi Stem Cells Center
Abu Dhabi, United Arab Emirates, 4600