REMdesivir-HU Clinical Study and Severe Covid-19 Patients
SARS-CoV-2 Infection
About this trial
This is an interventional treatment trial for SARS-CoV-2 Infection focused on measuring SARS-CoV-2, COVID-19
Eligibility Criteria
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.
Sites / Locations
- Department of Pulmonology Semmelweis University
- National Korányi Institute for Pulmonology
- North - Central Buda Center New St. János Hospital
- Institute of Infectology, University of Debrecen
- 1st Department of Medicine, University of Pécs
- Department of Internal Medicine University of Szeged
- First Department of Internal Medicine, University of Szeged
Arms of the Study
Arm 1
Experimental
Remdesivir-HU
Day 1 - single loading dose of remdesivir-HU 200 mg given by intravenous infusion • Day 2 onwards - 100 mg given once daily by intravenous infusion.