Covid19
Conditions
Brief summary
This is a Phase II multi-center, double-blind, placebo-controlled, randomized study in Patients with moderate to severe lung injury due to COVID-19 or other potential viral and bacterial pathogens.
Detailed description
This is a Phase II multi-center, double-blind, placebo-controlled, randomized study in Patients with moderate to severe lung injury due to COVID-19 or other potential viral and bacterial pathogens. The study will enroll up to 40 Patients into two cohorts, randomized 1:1 to receive active study drug plus standard treatment or placebo (LRS) plus standard treatment. On the treatment (Day 0) Cohort 1 will receive a single IV dose of hMSCs Cohort 2 will receive Lactated Ringer's Solution. A second dose of MSCs or LRS will be given to Cohort 1 or Cohort 2, respectively on Day 3 after the first dose. Patients who discontinue the study before Month 1 for reasons other than adverse events will be replaced.
Interventions
BIOLOGICALhMSC
IV administration
Sponsors
bioRASI, LLC
Stemedica Cell Technologies, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
This is double-blind study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Laboratory-confirmed diagnosis of COVID-19 \<= 14 days prior to randomization * The presence of moderate to severe Acute Respiratory Distress Syndrome (ARDS) as defined by the Berlin Definition: 1. Bilateral chest radiograph infiltrates. 2. PaO2:FiO2 ratio of less than 200. 3. Absence of other clinical conditions that could present in a similar manner (non-infectious pneumonitis, cardiogenic pulmonary edema) * Absence of moribund state that would indicate imminent demise and poor chance of survival.
Exclusion criteria
* Females of childbearing potential who are pregnant or unwilling to undergo pregnancy testing; females with a positive pregnancy test on screening day will be excluded. * Breastfeeding mothers * Patients on ECMO * Receiving concurrent treatment with an investigational agent in a clinical trial. * Exception: Use of COVID-19 convalescent plasma is permitted. * More than 72hrs on mechanical ventilation before randomization * Receiving concurrent investigational vaccine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival | 14 days post treatment | Number of patients alive at day 14 post treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with treatment-related adverse events as assessed by CTCAE v4.0 | 9 months | Frequency of adverse events in patients treated with hMSCs and Lactate Ringer's solutions will be compared. |
Countries
United States
Contacts
Primary ContactLev Verkh, PhD/MS
Outcome results
None listed