NCT04371393

MSCs in COVID-19 ARDS

Mesenchymal Stromal Cells for the Treatment of Moderate to Severe COVID-19 Acute Respiratory Distress Syndrome

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 223 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The mortality rate in SARS-CoV-2-related severe ARDS is high despite treatment with antivirals, glucocorticoids, immunoglobulins, and ventilation. Preclinical and clinical evidence indicate that MSCs migrate to the lung and respond to the pro-inflammatory lung environment by releasing anti-inflammatory factors reducing the proliferation of pro-inflammatory cytokines while modulating regulatory T cells and macrophages to promote resolution of inflammation. Therefore, MSCs may have the potential to increase survival in management of COVID-19 induced ARDS. The primary objective of this phase 3 trial is to evaluate the efficacy and safety of the addition of the mesenchymal stromal cell (MSC) remestemcel-L plus standard of care compared to placebo plus standard of care in patients with acute respiratory distress syndrome (ARDS) due to SARS-CoV-2. The secondary objective is to assess the impact of MSCs on inflammatory biomarkers.

Detailed description

This will be a randomized (1:1 ratio), double blind, parallel design, placebo controlled trial. Randomization will be stratified by clinical center and by moderate versus severe ARDS. The study is designed to have three interim analyses for stopping accrual early for efficacy and futility when 30%, 45% and 60% of the 300 patients have reached the primary endpoint using Bayesian predictive probabilities. Patients will be randomized in a 1:1 allocation to intravenous infusion of MSCs (remestemcel-L) plus standard of care versus placebo plus standard of care for the treatment of COVID-19 related ARDS: * Group 1: 2x10\^6 MSC/kg of body weight plus standard of care, administered twice during the first week, with the second infusion at 4 days following the first infusion (± 1 day) * Group 2: Placebo (Plasma-Lyte) plus standard of care, administered twice during the first week, with the second infusion at 4 days following the first infusion (± 1 day) (control) MSCs and placebo will initially be administered intravenously in the dose defined above at randomization. The rate of infusion may be tailored to the patient's respiratory status and fluid status, but the duration of infusion should not exceed 60 minutes. Patients will be followed for 90 days post randomization, with assessment of pulmonary symptoms at 6 and 12 months.

Conditions

• Mesenchymal Stromal Cells
• Remestemcel-L
• Acute Respiratory Distress Syndrome
• COVID

Interventions

Type	Name	Description
BIOLOGICAL	Remestemcel-L	administered twice during the first week, with the second infusion at 4 days following the first injection (± 1 day)
DRUG	Placebo	administered twice during the first week, with second infusion at 4 days following the first injection (± 1 day)

Timeline

• Start date: 2020-04-30
• Primary completion: 2021-01-14
• Completion: 2022-01-02
• First posted: 2020-05-01
• Last updated: 2022-04-25

Locations

21 sites across 1 country: United States

Regulatory

• FDA-regulated drug study