CovidResearchTrials by Shray Alag

CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)

COVID-19 standard careWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (1)

Name (Synonyms) Correlation
drug250 Autologous Non-Hematopoietic Peripheral Blood Stem Cells (NHPBSC) Wiki 1.00

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D018352 Coronavirus Infections NIH 0.04

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 Adaptive Open-label Study Evaluating the Safety and Efficacy of Autologous Non- Hematopoietic Peripheral Blood Stem Cells Therapy in COVID-19 Outbreak in Abu Dhabi, 2020 (SENTAD-COVID Study)

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-19) infection during the outbreak in Abu Dhabi, 2020. The patients were randomly allocated in a parallel assignment involving two groups of participants: Group A (Experimental arm): autologous non-hematopoietic peripheral blood stem cells (NHPBSC) therapy as add-on COVID-19 standard care, or Group B (No investigational intervention arm): COVID-19 standard care. Standard care is defined as per the "UAE National Guidelines for Clinical Management and Treatment of COVID-19". SENTAD-COVID Study was conducted in the Sheikh Khalifa Medical City (SKMC) of Abu Dhabi, as Primary Care Clinical Trial Unit, while the cell processing and investigational product formulation were completed by Abu Dhabi Stem Cells Center (ADSCC), according to Good Laboratory Practices (GLPs) and Good Manufacturing Practices (GMPs).

NCT04473170 Coronavirus Disease 2019 (COVID-19) Biological: Autologous Non-Hematopoietic Peripheral Blood Stem Cells (NHPBSC) Drug: COVID-19 standard care
MeSH:Coronavirus Infections

Primary Outcomes

Description: Proportion of participants with treatment-related Adverse Event as assessed by CTCAE v5.0.

Measure: Adverse reactions incidence.

Time: Day 0 - 28

Description: Incidence of deaths within 28-days in enrolled patients.

Measure: Rate of mortality within 28-days.

Time: Day 0 - 28

Description: Days from administration of the Investigational Product to improvement of seven-category ordinal scale by at least 2 points.

Measure: Time to clinical improvement on a seven-category ordinal scale.

Time: Day 0 - 28

Secondary Outcomes

Description: Immune response profile characterized according the biomarkers: CD3, CD4, CD8, CD11c, CD14, CD16, CD19, CD20, CD25, CD27, CD28, CD38, CD45, CD45RA, CD45RO, CD56, CD57, CD66b, CD123, CD127, CD161, CD294, CCR4, CCR6, CCR7, CXCR3, CXCR5, HLA-DR, IgD, and TCRγδ, for the identification of immune cells and subsets analysis; and the humoral Immune profile: IgG, IgA, IgM levels.

Measure: Assessment of the immune response profile.

Time: Days 0, 14, and 28

Description: Complete Blood Counts (CBC), Acute phase proteins and Inflammatory markers: CRP, ESR, LDH, Procalcitonin (PCT), Ceruloplasmin, Haptoglobin, alpha 1 antitrypsin, IL-6, ferritin C3, PT, fibrinogen and D-dimer.

Measure: Assessment of acute-phase serum markers.

Time: Days 0, 14, and 28

No related HPO nodes (Using clinical trials)