NCT05497401

Brief Summary

The efficacy of the allogeneic cell-therapy product MesenCure in addition to standard of care will be evaluated in comparison to placebo control in 300 moderate to severe Covid patients

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
28mo left

Started Apr 2026

Status
not yet recruiting

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 Progress6%
Apr 2026Oct 2028

First Submitted

Initial submission to the registry

August 8, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 11, 2022

Completed
3.6 years until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

August 11, 2025

Status Verified

December 1, 2024

Enrollment Period

2.2 years

First QC Date

August 8, 2022

Last Update Submit

August 6, 2025

Conditions

ARDS

Outcome Measures

Primary Outcomes (3)

  • Mortality

    1 month

  • CRP reduction

    Blood CRP is measured in mg/dL

    14 days

  • Invasive ventilation

    1 month

Study Arms (2)

treatment

EXPERIMENTAL
Biological: MesenCure

control

PLACEBO COMPARATOR
Other: Placebo

Interventions

MesenCureBIOLOGICAL

Enhanced mesenchymal cell-based product

treatment
PlaceboOTHER

Saline

control

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients are able and agree to sign informed consent form before any study-specific procedure.
  • Males or females, age range 18-80.
  • Documented ARDS
  • RA-O2 Saturation of ≤93% and/or Evidence of COVID19-related pulmonary infiltrates on chest X-ray/thoracic tomography
  • Stable hemodynamic condition (blood pressure of systolic \<180mm Hg and diastolic \<110mm Hg)

You may not qualify if:

  • General:
  • Pregnant or breast-feeding females.
  • History of drug abuse.
  • Heavy smokers (above 2 packages a day).
  • Subjects incapable of giving consent.
  • Background medical conditions:
  • Known history of any significant medical disorder, which in the investigator's judgment contraindicates the subject's participation.
  • History of advanced congestive heart failure or active acute myocardial infarction (AMI), renal failure (estimated GFR of \<30 ml/min/1.73 m2 at screening), or hepatic disease (hepatic insufficiency classified as Child-Pugh B or C).
  • Known autoimmune diseases.
  • Immunocompromised condition from any reason, at screening.
  • Abnormal clinically significant laboratory test findings, as per the investigator's judgment.
  • Poorly controlled diabetic subjects (HbA1c \> 9%).
  • Known active lung malignancy.
  • Concomitant treatment:
  • Currently treated with Immunosuppressive agents other than corticosteroids used for treating COVID19.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2022

First Posted

August 11, 2022

Study Start

April 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

October 1, 2028

Last Updated

August 11, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share