This is a Phase 3, open-label, multi-center, interventional safety study of REM therapy in participants 12 years of age or older with COVID-19, pneumonia and oxygen supplementation.
Drug: Remdesivir-HU
Remdesivir-HU 100 mg concentrate for solution for infusion
Inclusion Criteria:
- 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).
Exclusion Criteria:
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.
Department of Pulmonology Semmelweis University
Budapest, Hungary
National Korányi Institute for Pulmonology
Budapest, Hungary
North - Central Buda Center New St. János Hospital
Budapest, Hungary
Institute of Infectology, University of Debrecen
Debrecen, Hungary
1st Department of Medicine, University of Pécs
Pécs, Hungary
Department of Internal Medicine University of Szeged
Szeged, Hungary
First Department of Internal Medicine, University of Szeged
Szeged, Hungary