Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT04371393
Eligibility Criteria:
Inclusion Criteria
* 18 years or older
* Patient has SARS-CoV-2 (COVID-19) confirmed by real-time reverse transcription polymerase chain reaction (RT-PCR) assay or other diagnostic test
* Patient requiring mechanical ventilatory support with moderate to severe ARDS as determined by the following criteria (adapted from the Berlin criteria)
* Bilateral opacities must be present on a chest radiograph or computerized tomographic (CT) scan. These opacities are not fully explained by pleural effusions, lobar collapse, lung collapse, or pulmonary nodules.
* Respiratory failure not fully explained by cardiac failure or fluid overload.
* Moderate to severe impairment of oxygenation must be present, as defined by the ratio of arterial oxygen tension to fraction of inspired oxygen (PaO2/FiO2). The severity of the hypoxemia defines the severity of the ARDS:
* Moderate ARDS: PaO2/FiO2 \>100 mmHg and ≤200 mmHg, on ventilator settings that include PEEP ≥5 cm H2O OR
* Severe ARDS: PaO2/FiO2 ≤100 mmHg on ventilator settings that include PEEP ≥5 cm H2O
* High sensitivity C-Reactive Protein (hs-CRP) or CRP serum level \>4.0 mg/dL
* Acute Physiologic and Chronic Health Evaluation (APACHE IV) score \>5
* Creatinine clearance of ≥ 30 mL/minute OR a creatinine clearance of 20-29 mL/minute with urine output of ≥0.3 mLs/kg/hour over the last 8 hours or ≥500 mLs over the last 24 hours
* The patient or his/her legally authorized representative (LAR) is able to provide informed consent
Exclusion Criteria
* Currently receiving extracorporeal membrane oxygenation (ECMO) or high frequency oscillatory ventilation (HFOV)
* Females who are pregnant or lactating
* Patients with established positive bacterial blood cultures prior to enrollment or suspicion of superimposed bacterial pneumonia
* Patients with BMI \>55
* Patients with untreated HIV infection
* Patients with malignancy who are within 12 months of active treatment with any chemotherapy, radiation or immunotherapy.
* Patients who have been intubated for more than 72 hours in total at the time of randomization
* Creatinine clearance less than 20 mL/minute or receiving renal replacement therapy
* LFTs (isolated ALT or AST) \> 8x upper limit of normal or \> 5x upper limit of normal in the setting of other liver function abnormalities (i.e., total bilirubin ≥ 2x upper limit of normal)
* Known hypersensitivity to DMSO or to porcine or bovine proteins
* History of prior respiratory disease with requirement for supplemental oxygen
* Any end-stage organ disease which in the opinion of the investigator may possibly affect the safety of remestemcel-L treatment
* Receiving an investigational cellular therapy agent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04371393
Study Brief:
Protocol Section:
NCT04371393