Correlated Drug Terms (1)

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	Name (Synonyms)	Correlation
drug276	BAT2020 Wiki	1.00

Correlated MeSH Terms (3)

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	Name (Synonyms)	Correlation
D055371	Acute Lung Injury NIH	0.10
D012127	Respiratory Distress Syndrome, Newborn NIH	0.10
D012128	Respiratory Distress Syndrome, Adult NIH	0.09

Correlated HPO Terms (0)

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	Name (Synonyms)	Correlation

Primary Outcomes

Description: The incidence of pre-specified treatment related adverse events of interest (TRAEIs) occurring during the 10 days interval beginning with the start of the ATIMP infusion: New ventricular tachycardia, ventricular fibrillation or asystole within 10 days after infusion New cardiac arrhythmia requiring cardioversion within 10 days after infusion Clinical scenario consistent with transfusion incompatibility or transfusion-related infection within 10 days after infusion Thromboembolic events (e.g. Pulmonary embolism) within 10 days after infusion Cardiac arrest or death within 10 days after infusion

Measure: The incidence of pre-specified treatment related adverse events of interest (TRAEIs).

Time: From drug administration to day 10 post-infusion

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Secondary Outcomes

Description: All-cause mortality at 60 days and then annually

Measure: Safety; All-cause mortality

Time: 60 days post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion

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Description: Changes from baseline (Day 1; prior to administration of ATIMP) in the leucocyte Count (number/L)

Measure: Changes in Leucocytes

Time: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion

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Description: Changes from baseline (Day 1; prior to administration of ATIMP) in the trombocyte Count (number/L)

Measure: Changes in Trombocytes

Time: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion

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Description: Changes from baseline (Day 1; prior to administration of ATIMP) in the plasma concentration of CRP (mg/L)

Measure: Changes in plasma concentration of C-reactive protein (CRP)

Time: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion

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Description: Changes from baseline (Day 1; prior to administration of ATIMP) in the plasma concentration of PK (INR)

Measure: Changes in plasma concentration of Prothrombin complex (PK)

Time: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion

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Description: Changes from baseline (Day 1; prior to administration of ATIMP) in the plasma concentration of creatinine (μmol/L)

Measure: Changes in plasma concentration of Creatinine

Time: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion

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Description: Changes from baseline (Day 1; prior to administration of ATIMP) in the plasma concentration of ASAT (μkat/L)

Measure: Changes in plasma concentration of Aspartate amino transferase (ASAT)

Time: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion

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Description: Changes from baseline (Day 1; prior to administration of ATIMP) in the plasma concentration of ALAT (μkat/L)

Measure: Changes in plasma concentration of Alanine amino transferase (ALAT)

Time: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion

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Description: Changes from baseline (Day 1; prior to administration of ATIMP) in the plasma concentration of NT-proBNP (ng/L)

Measure: Changes in plasma concentration of N-terminal pro-brain natriuretic peptide (NT-proBNP)

Time: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion

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Description: Changes from baseline (Day 1; prior to administration of ATIMP) in blood pressure (mmHg)

Measure: Changes in Blood pressure

Time: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion

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Description: Changes from baseline (Day 1; prior to administration of ATIMP) in body temperature (°C)

Measure: Changes in Body temperature

Time: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion

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Description: Changes from baseline (Day 1; prior to administration of ATIMP) in pulmonary compliance (dynamic and static) until day 10 post-infusion

Measure: Efficacy; Changes in pulmonary compliance

Time: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion

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Description: Changes from baseline (Day 1; prior to administration of ATIMP) in driving pressure (Plateau pressure- PEEP) until day 10 post-infusion

Measure: Efficacy; Changes in driving pressure (Plateau pressure- PEEP)

Time: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion

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Description: Changes from baseline (Day 1; prior to administration of ATIMP) in oxygenation (PaO2/FiO2) until day 10 post-infusion

Measure: Efficacy; Changes in oxygenation (PaO2/FiO2)

Time: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion

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Description: Number of days with ventilator support

Measure: Efficacy; Duration of ventilator support

Time: Baseline (pre-infusion),day 1, 2, 3, 4, 7, 10 and 60 post-infusion

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Description: Changes in amount of pulmonary bilateral infiltrates assessed by pulmonary X-ray from baseline (Day 1; prior to administration of ATIMP) until day 60

Measure: Efficacy; Pulmonary bilateral infiltrates

Time: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion

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Description: Changes in Sequential Organ Failure Assessment (SOFA) score from baseline (Day 1; prior to administration of ATIMP) and during the ICU-period

Measure: Efficacy; Sequential Organ Failure Assessment (SOFA) score

Time: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, end of ICU

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Description: Duration of ICU stay and hospital stay (number of days; whole hospital period + calculated from Day 1)

Measure: Efficacy; Hospital stay

Time: Day 60 post-infusion

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Description: Recovery of lung function assessed by Spirometry (FEV1, Vital Capacity) at day 60 and then annually

Measure: Lung function

Time: Day 60 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion

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Description: To assess development of lung fibrosis using the HRCT Fibrosis Score using Computed tomography (CT) at baseline and on day 1, 3, 7, 10, end of ICU-residence, end of hospital stay, day 60, 6 month and 12 month and end of study (if possible during the infectious stage depending on hospital safety regimen during the pandemic).

Measure: Lung fibrosis

Time: Baseline (pre-infusion), day 1, 3, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion

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Description: Assessment of the patient's physical capacity by 6-Minute-Walk-Test (6MWT), starting at 6 months post Day 1 and then annually

Measure: Six minutes walk test

Time: 6 months, 1, 2, 3, 4 and 5 years post-infusion

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Description: Changes in Quality of Life by assessing the Short Form Health Survey (SF-36) score (starting at 6 months post Day 1 and then annually; patient reported outcome)

Measure: Changes in Quality of life

Time: 6 months, 1, 2, 3, 4 and 5 years post-infusion

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Description: Change in blood biomarkers related to the proposed mechanisms of action of KI-MSC-PL-205 in ARDS

Measure: Blood biomarkers

Time: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion

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Description: Sensitisation tests (test for donor-specific antibodies) against KI-MSC-PL-205 donor

Measure: Sensitisation test

Time: Baseline (pre-infusion), day 60 post-infusion

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