Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Pecs
With
HECRIN Consortium
Ministry of Innovation and Technology, Hungary
Age
12–100
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Males or females aged 12yrs and older with body weight at least 40kg
Hospitalized with COVID-19 confirmed by PCR and/or COVID-19 typical symptoms with pneumonia:
▪ In case of no confirmed PCR test result available at screening, typical symptoms can also apply
requiring supplemental oxygen at screening
▪ at the discretion of the investigator, any form of O2 support can apply
Do not have access to Veklury treatment
▪ Patient may be under other treatment against COVID-19 (except for chloroquine/hydroxychloroquine)
Willing and able to provide valid written informed consent prior to performing study procedures (for those \<18yrs of age, parental consent and patient assent is required). For an unconscious or comatose patient written informed consent given by next of kin or a legal representative is also accepted. If none of the above consents are available the investigator can enroll the patient as described in 21 CFR 50.24 (involving emergency research).
You may not be if
Known liver disease, hepatic impairment and/or Alanine Transaminase (ALT) or Aspartate Transaminase (AST) ≥ 5 times the upper limit of normal
Known severe renal disease (including patients receiving hemodialysis or hemofiltration) and/or estimated glomerular filtration rate (eGFR) \< 30 ml/min.
Pregnancy or breast feeding at the discretion of the investigator
Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 120 hours
Know allergy to any anti-viral medication
Hypersensitivity to the active substance(s) or to any of the excipients
Current (or 48 hours prior) treatment with chloroquine/hydroxychloroquine Other investigationsl treatment up to 2x the "emptying" time of treatment, or if this is not known for 60 days, except in the case of a favipiravir study. In case of the clinical trial of favipiravir the petinents can be enrolled in the study if afterthe end of study / early termination visit.
Any medical condition that the examining physician deems unsuitable for the patient to participate in the study.
Clareo Health | REMdesivir-HU Clinical Study and Severe Covid-19 Patients
