REMdesivir-HU Clinical Study and Severe Covid-19 Patients

Recruitment & Eligibility

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.

Study & Design

Arm && Interventions

Group	Intervention	Description
Remdesivir-HU	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.

Primary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of REM use in Hungary in the conditionally approved indication (EMA)	30 days	The primary endpoint of the study is the proportion of patients with at least one treatment-emergent AESI (hypersensitivity including infusion-related reaction, anaphylactic reaction, acute respiratory failure, hypotension, hepatic toxicity and nephrotoxicity).

Secondary Outcome Measures

Name	Time	Method
The proportion of patients with at least 1 treatment-emergent adverse event	30 days	Secondary safety endpoint
Proportion of patients with treatment-emergent clinical	30 days	Secondary safety endpoint laboratory abnormalities (separately for the following parameters: ALT, AST, INR, HGB, Bilirubin, ALP, Creatinine, eGFR)

Trial Locations

Locations (7)

Institute of Infectology, University of Debrecen

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Debrecen, Hungary

1st Department of Medicine, University of Pécs

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Pécs, Hungary

North - Central Buda Center New St. János Hospital

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Budapest, Hungary

National Korányi Institute for Pulmonology

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Budapest, Hungary

Department of Pulmonology Semmelweis University

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Budapest, Hungary

Department of Internal Medicine University of Szeged

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Szeged, Hungary

First Department of Internal Medicine, University of Szeged

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Szeged, Hungary

Recruitment & Eligibility