SARS-CoV-2 Infection MedDRA version: 23.0 Level: PT Classification code 10084268 Term: COVID-19 System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Remdesivir-HU 100 mg concentrate for solution for infusion
Pharmaceutical Form: Infusion
Sponsors
Hungarian Ministry of Innovation and Technology - Representative: Hecrin Consortium
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: o Males or females aged 12yrs and older with body weight at least 40kg o 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 o requiring supplemental oxygen at screening ? at the discretion of the investigator, any form of O2 support can apply o Do not have access to Veklury treatment ? Patient may be under other treatment against COVID-19 (except for chloroquine/hydroxychloroquine) o Willing and able to provide valid written informed consent prior to performing study procedures (for those =65 years) yes F.1.3.1 Number of subjects for this age range 360
Exclusion criteria
Exclusion criteria: Patients meeting any of the below criteria are not eligible o Known liver disease, hepatic impairment and/or Alanine Transaminase (ALT) or Aspartate Transaminase (AST) = 5 times the upper limit of normal o Known severe renal disease (including patients receiving hemodialysis or hemofiltration) and/or estimated glomerular filtration rate (eGFR) < 30 ml/min. o Pregnancy or breast feeding at the discretion of the investigator o Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 120 hours o 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. o Know allergy to any anti-viral medication ? Hypersensitivity to the active substance(s) or to any of the excipients o Current (or 48 hours prior) treatment with chloroquine/hydroxychloroquine o Any medical condition that the examining physician deems unsuitable for the patient to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of REM use in Hungary in the conditionally approved indication (EMA).;Secondary Objective: To evaluate the efficacy of REM in COVID-19 patients Hungary;Primary end point(s): The primary endpoint of the study is the proportion of patients with at least 1treatment-emergent AESI (death, hypersensitivity including infusion-related reaction, anaphylactic reaction, acute respiratory failure, hypotension, hepatic toxicity and nephrotoxicity). Secondary endpoints: The secondary safety endpoints of the study are: the proportion of patients with at least 1 treatment-emergent adverse event proportion of patients with treatment-emergent clinical laboratory abnormalities (separately for the following parameters: ALT, AST, INR, HGB, Bilirubin, ALP, Creatinine, eGFR) ;Timepoint(s) of evaluation of this end point: 10 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): time to recovery (days) time to discharge from hospital (days) number and proportion of patients at prespecified timepoints in each category of the WHO Ordinal Scale for Clinical Improvement number and proportion of patients at prespecified timepoints in each category (Ambient air, Low flow, Medium Flow, High Flow, Non invasive ventilation, Invasive ventilation, ECMO) proportion of participants with normalization of fever ( proportion of participants with normalization of oxygen saturation (>=95%) through Day 10 with 14 days follow-up after the last dose ;Timepoint(s) of evaluation of this end point: 10 months | — |
Countries
Hungary
Contacts
Public ContactCRO
AdWare Research Ltd.
Outcome results
None listed