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. 2021 Feb 9;22:126. doi: 10.1186/s13063-021-05033-x
Day ± window Screen Baseline Daily until discharge 6 ± 2 15 ± 2 29 ± 3 5–7 weeks post-discharge Day 90
− 3 to 0 0
Assessments/procedures
Eligibility
  Informed consent X
  Demographics and medical history X
  Review COVID-19 criteria X
  Inclusion and exclusion criteria X
Studyintervention
  Randomization X
  Administration of study drug X Daily for 5 days
Studyprocedures
  Vital signs including SpO2 X X Daily until discharge
  Clinical data collection X X Daily until discharge X
  Targeted medication review X X Daily until discharge X
  Adverse event evaluation X X Daily until discharge X
  ECGb X X QT monitoring scheme
  Evaluation by telephone X X If outpatient visit is not feasible x
  Evaluation on outpatient clinic Xa
  Spirometry + reversibility Xa
  Lung volumes + diffusion Xa
  Low-dose CT scan Xa
  6-min walking distance Xa
Laboratory
  CRP, hematology, chemistry, kidney and liver test X At clinician’s discretion At clinician’s discretion Xa
  Pregnancy test for females of childbearing potential X
  Viral qPCR (nasopharyngeal swab) If feasible

aIf clinically feasible

bQT monitoring scheme: Long QT (> 470 ms males and > 480 females) is an exclusion for participation. In patients with no long QT on ECG but at risk, a QT monitoring will be performed with intermittent ECG monitoring at days 2–3 or continuous follow-up on ICUs. When QTc > 500 ms and/or delta QTc > 60 ms, IMP will be interrupted/discontinued at the discretion of the investigator. The patient’s medication will be reviewed daily to evaluate DDIs including drugs prolonging the QTc interval according to what is listed in the protocol (see Additional file 1)