NCT04473170

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-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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2020

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2020

Completed
Last Updated

July 16, 2020

Status Verified

July 1, 2020

Enrollment Period

2 months

First QC Date

July 14, 2020

Last Update Submit

July 15, 2020

Conditions

Coronavirus Disease 2019 (COVID-19)

Keywords

COVID-19Non-Hematopoietic Peripheral Blood Stem Cells

Outcome Measures

Primary Outcomes (3)

  • Adverse reactions incidence.

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

    Day 0 - 28

  • Rate of mortality within 28-days.

    Incidence of deaths within 28-days in enrolled patients.

    Day 0 - 28

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

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

    Day 0 - 28

Secondary Outcomes (2)

  • Assessment of the immune response profile.

    Days 0, 14, and 28

  • Assessment of acute-phase serum markers.

    Days 0, 14, and 28

Study Arms (2)

Group A

EXPERIMENTAL

Autologous Non-Hematopoietic Peripheral Blood Stem Cells (NHPBSC) therapy as add-on COVID-19 standard care.

Biological: Autologous Non-Hematopoietic Peripheral Blood Stem Cells (NHPBSC)

Group B

ACTIVE COMPARATOR

COVID-19 Standard care.

Drug: COVID-19 standard care

Interventions

Autologous Non-Hematopoietic Peripheral Blood Stem Cells (NHPBSC)BIOLOGICAL

SENTAD-COVID Study intervention consists of Autologous Non-Hematopoietic Peripheral Blood Stem Cells (NHPBSC) therapy through jet nebulization in addition to standard care. The NHPBSC were characterized as CD90+, CD133+, Oct-4+ (pluripotent markers), and CD45-, CD71-, based on multiparameter flow cytometry.

Also known as: UAECell19
Group A
COVID-19 standard careDRUG

UAE National Guidelines for Clinical Management and Treatment of COVID-19.

Also known as: Current COVID-19 standard care in the UAE
Group B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abu Dhabi Stem Cells Center

Abu Dhabi, 4600, United Arab Emirates

Location

Related Publications (2)

  • Castillo Aleman YM, Villegas Valverde CA, Ventura Carmenate Y, Abdel Hadi L, Rivero Jimenez RA, Rezgui R, Alagha SH, Shamat S, Bencomo Hernandez AA. Viability assessment of human peripheral blood-derived stem cells after three methods of nebulization. Am J Stem Cells. 2021 Oct 15;10(4):68-78. eCollection 2021.

    PMID: 34849303DERIVED

  • Ventura-Carmenate Y, Alkaabi FM, Castillo-Aleman YM, Villegas-Valverde CA, Ahmed YM, Sanna P, Almarzooqi AA, Abdelrazik A, Torres-Zambrano GM, Wade-Mateo M, Quesada-Saliba D, Abdel Hadi L, Bencomo-Hernandez AA, Rivero-Jimenez RA. Safety and efficacy of autologous non-hematopoietic enriched stem cell nebulization in COVID-19 patients: a randomized clinical trial, Abu Dhabi 2020. Transl Med Commun. 2021;6(1):25. doi: 10.1186/s41231-021-00101-5. Epub 2021 Nov 3.

    PMID: 34746417DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Yendry Ventura Carmenate, M.D.

    Abu Dhabi Stem Cells Center (ADSCC)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Masking Details
None (open-label)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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. * Group B (No investigational intervention arm): COVID-19 standard care.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2020

First Posted

July 16, 2020

Study Start

April 4, 2020

Primary Completion

May 20, 2020

Study Completion

July 14, 2020

Last Updated

July 16, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

AE(1)