Days on Intervention | Screening | 1 | 2 | 3 | 5 | 6 | 9 | 11 | 13 | 15 | 19 | 60 | 90 | 180 | 270 | 365 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Informed Consent | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Demographics | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Medical History | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | X | X | X | X | X |
Eligibility Review | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Symptom Assessment | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | X | X | X | X | X |
Complete Physical Exam | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | X | X | X | X | X |
Vital signs | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | X | X | X | X | X |
Routine Blood tests | X | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Protocol Specific Testsa | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Pregnancy Test (if applicable) | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Experimental Arm Only | ||||||||||||||||
 Experimental Blood Specimens |  | Before therapy |  |  |  |  |  |  |  |  |  | X | X | X | X | X |
 Routine Blood tests | X | X | X | X | X | X | X | X | X | X |  |  |  |  |  |  |
 O2 requirement assessment |  | Before therapy |  |  |  |  |  |  |  |  | After therapy | X | X | X | X | X |
 TPE Collection |  | 500 ml + 50 ml |  | 50 ml |  |  | 50 ml |  |  | 50 ml |  |  |  |  |  |  |
 6- minute walk distance |  | Before therapy |  |  |  |  |  |  |  |  | After therapy | X | X | X | X | X |
Treatment as Usual Arm Only | ||||||||||||||||
 Experimental Blood Specimens |  | X |  |  |  |  |  |  |  |  |  | X | X | X | X | X |
 O2 requirement assessment |  | X |  |  |  |  |  |  |  |  | Xb | X | X | X | X | X |
 6- minute walk distance |  | X |  |  |  |  |  |  |  |  | Xb | X | X | X | X | X |
Adverse Event Monitoring | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X |