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Table 2 Schedule of assessments during trial period

From: Repair of acute respiratory distress syndrome by stromal cell administration (REALIST): a structured study protocol for an open-label dose-escalation phase 1 trial followed by a randomised, triple-blind, allocation concealed, placebo-controlled phase 2 trial

 

Day 0

Day 1

Days 2–3

Day 4

Days 5–6

Day 7

Days 8–13

Day 14

Days 15–28

Day 90 (± 14 days)

1 year (± 30 days)

2 years (± 30 days)

Eligibility assessment

X

           

Informed consent

X

           

Enrolment/randomisation

X

           

Baseline data

X

           

Daily data

 

X

X

X

X

X

X

X

    

Chlorphenamine administration

 

X

          

IMP administration

 

X

          

Adverse events

 

X

X

X

X

X

X

X

X

X

  

ECHO data (phase 2 only)

X

  

X

        

BAL sampling (where possible)

X

  

X

        

Blood sampling

X

  

X

 

X

 

X

  

X

X

Anti-HLA Ab

X

       

X

   

Urine sampling

X

  

X

 

X

 

X

    

Mortality

        

X

X

X

X

Medical event

          

X

X

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Trials

ISSN: 1745-6215