NCT04390139

Brief Summary

Randomized, double-blind, parallel, two-arms clinical trial to assess the efficacy and safety of 2 infusions of Wharton-Jelly mesenchymal stromal cells (day 1 and day 3, endovenously at 1E6cells/Kg per dose) in patients with moderate acute respiratory distress syndrome (ARDS) secondary to SARS-CoV-2 infection. Follow-up will be established on days 3, 5, 7, 14, 21, and 28. Long term follow-up will be performed at 3, 6 and 12 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at P25-P50 for phase_1 covid19

Timeline
Completed

Started May 2020

Longer than P75 for phase_1 covid19

Geographic Reach
1 country

5 active sites

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

First Submitted

Initial submission to the registry

May 7, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

May 13, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2022

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

2.6 years

First QC Date

May 7, 2020

Last Update Submit

January 24, 2023

Conditions

COVID-19SARS-CoV 2Adult Respiratory Distress Syndrome

Keywords

ARDS

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality at day 28

    Number of patients who died, by treatment group

    Day 28

Secondary Outcomes (15)

  • Safety of WJ-MSC

    Day 28

  • Need for treatment with rescue medication

    Day 28

  • Need and duration of mechanical ventilation

    Day 28

  • Ventilator free days

    Day 28

  • Evolution of PaO2 / FiO2 ratio

    Day 28

  • +10 more secondary outcomes

Other Outcomes (6)

  • Analysis of subpopulations of lymphocytes and immunoglobulins

    Day 28

  • Evaluation of the in vitro response of the receptor lymphocytes

    Day 28

  • Study of reactivity against SARS-CoV-2 peptides

    Day 28

  • +3 more other outcomes

Study Arms (2)

Treatment A

EXPERIMENTAL

Wharton-Jelly mesenchymal stromal cells on D1 and D3

Drug: XCEL-UMC-BETA

Treatment B

PLACEBO COMPARATOR

Placebo on D1 and D3

Other: Placebo

Interventions

XCEL-UMC-BETADRUG

Administration on top of the standard administered treatment

Also known as: WJ-MSC
Treatment A
PlaceboOTHER

Administration on top of the standard administered treatment

Treatment B

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Positive PCR fpr SARS-CoV-2
  • Intensive Care Unit admission for less than 3 days
  • Moderate acute respiratory distress (Berlin criteria definition with 100 mmHg \< PaO2/FiO2 ≤ 200 mmHg)
  • Male or female, aged 18 to 70 years old
  • Signed informed consent by the patient or by a legal representative (in this case, can be obtained by phone, although it must be confirmed in writing later, accepted by email)

You may not qualify if:

  • Expected survival less than 3 days
  • Treatment with immunosuppressive drugs (tocilizumab, sarilumab) with corticosteroids being allowed
  • Neoplastic disease either active or without complete remission
  • Immunosuppressed patients (except treatment with corticosteroids for respiratory distress)
  • Pregnant or lactating women
  • Participation in another clinical trial with an experimental drug in the last 30 days
  • Other pathologies that, in medical judgment, contraindicate participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hospital de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Mútua de Terrassa

Terrassa, Barcelona, 08221, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

Related Links

MeSH Terms

Conditions

COVID-19Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

  • Antoni Torres, MD, PhD

    Hospital Clinic of Barcelona

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2020

First Posted

May 15, 2020

Study Start

May 13, 2020

Primary Completion

December 20, 2022

Study Completion

December 20, 2022

Last Updated

January 26, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(5)