Treatment of Respiratory Complications Associated With COVID-19 Using Umbilical Cord Mesenchymal … (NCT04869397) | Clinical Trial Compass
TerminatedPhase 2
Treatment of Respiratory Complications Associated With COVID-19 Using Umbilical Cord Mesenchymal Stromal Cells
Stopped: DSMB advised discontinuing the study prematurely because recruitment goals were not achieved.
Canada19 participantsStarted 2021-06-14
Plain-language summary
This is a randomized phase II placebo controlled clinical trial. Active arm: Allogeneic Wharton's jelly derived MSCs (WJ-MSCs). Both groups will receive standard of care treatment for COVID (e.g. dexamethasone)
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female, aged 18 years-old or older
* Laboratory-confirmed SARS-CoV-2 infection determined by reverse-transcription polymerase chain reaction (RT-PCR) prior to randomization
* Hospitalized patients
* Severe COVID-19 pneumonia defined as patients who cannot saturate \> 96% on 4 L/min but are NOT on "non-invasive" ventilation nor invasive mechanical ventilation nor Extracorporeal membrane oxygenation (ECMO). Patients on high flow would be eligible if they receive treatment in a non-critical care unit only.
* Use of contraception or acceptable birth control for the duration of the study in women of childbearing potential
* Provision of written or verbal informed consent by the patient or designated substitute decision maker
Exclusion Criteria:
* Inability to provide informed consent
* Patients expected to survive less than 24 hours
* Advanced directives of patient's wishes to refuse intubation.
* Patients on mechanical ventilation
* Pregnant women \[pregnancy defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotrophin (hCG) laboratory test\]
* Breastfeeding
* Weight \> 100 kg or \< 50 kg
* Cancer not in remission or active serious illness unrelated to COVID-19.
* Any of the following laboratory results at screening: Absolute neutrophil count (ANC) ≤ 1.0 x 109/L, Platelets (PLT) \< 50 G /L, Alanine transaminase (ALT) or Aspartate transaminase (AST) \> 5N, eGFR \< 30…
What they're measuring
1
Composite endpoint
Timeframe: at 15 days after intervention
Trial details
NCT IDNCT04869397
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre