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Table 1 Timeline of IXION. Overview of assessments and time points of visits during the study period

From: Potential of FX06 to prevent disease progression in hospitalized non-intubated COVID-19 patients — the randomized, EU-wide, placebo-controlled, phase II study design of IXION

  1. 1Screening and baseline should be maximally 5 days apart, but can also be performed at the same day; 2if patients are not in the hospital anymore, patients can be contacted remotely to retrieve the information; 3IMP administration will be performed at BL and the following 4 days; 4FU can be performed as a telephone call and will be performed at day 60; 5lung function parameters will only be documented if they are routinely measured; 6blood sample collection before first dose of IMP; 7only in women of childbearing potential; urine pregnancy test; 8to be administered as interview; 9WHO score will be eligible for the whole study period for evaluation of disease severity also if patients become SARS-CoV-2 negative during the study period; 10will be done in clinical routine by the local laboratory and will be documented for the study
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Trials

ISSN: 1745-6215