A Phase 1 Double-blinded, Randomized, Placebo-controlled Study for COVID-19 and Influenza Virus-Elicited Acute Respiratory Distress Syndrome (ARDS) Using Lomecel-B (RECOVER)

NCT04629105 Phase 1 UNKNOWN

A Phase I, double- blinded, randomized, placebo- controlled study to test the safety of Lomecel-B in Adults suffering from mild to severe acute respiratory distress syndrome (ARDS) due to COVID-19 resultant from 2019-nCoV coronavirus infection, or resultant from influenza virus infection.

Details

Lead sponsor	Longeveron Inc.
Phase	Phase 1
Status	UNKNOWN
Enrolment	70
Start date	2020-07-24
Completion	2025-07

Conditions

• ARDS, Human
• Covid19

Interventions

• Longeveron Mesenchymal Stem Cells (LMSCs)
• Placebo

Primary outcomes

• Incidence of Treatment-Emergent Serious Adverse Events — Within 4 weeks after treatment
  Incidence of treatment-emergent serious adverse events (TE-SAEs) within 4 weeks after treatment, defined as one or more of the following untoward medical occurrences happening within the first 4 weeks after treatment. i. Life-threatening event (e.g., stroke or non-fatal pulmonary embolism). ii. Event requiring inpatient hospitalization or prolongation of existing hospitalization (e.g., for worsening dyspnea). iii. Event resulting in persistent or significant disability/incapacity. iv. Event resulting in death. v. Event leading to other clinically significant untoward laboratory test result(s) or medical condition(s), as determined by the Investigator.
• Number of Participants with Abnormal Clinical Significant Laboratory Values in Hematology. — Baseline to 6 Months
  Number of Participants with Abnormal Clinical Significant Lab Values in the Hematology testing will be assessed at Baseline and 6 Months.
• Number of Participants with Changes in Echocardiography Overall Assessment — Baseline to 6 Months
  Overall Assessment Normal vs Abnormal will be collected at Baseline and 6 months, this change in overall assessment will be the outcome in numbers of particants with a change.
• Number of Participants with Changes to overall assessment of Electrocardiogram — Baseline to 6 Months
  Number of Participants with changes to Overall Assessment Normal vs Abnormal will be collected at Baseline and 6 Months
• Time to recovery of Sp02 — Baseline to 6 Months
  Time to recovery of Sp02 to 90% or higher on room air (or the oxygen concentration the patient had before acute illness) after 10 minutes of spontaneous breathing.
• Number of Participants with Abnormal Clinical Significant Lab Values in the Blood Chemistry testing. — Baseline to 6 months
  Number of Participants with Abnormal Clinical Significant Lab Values in Blood Chemistry testing will be assessed at Baseline and 6 Months.

Countries

United States