SARS-CoV-2 Infection
Conditions
Keywords
SARS-CoV-2, COVID-19
Brief summary
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.
Interventions
DRUGRemdesivir-HU
Remdesivir-HU 100 mg concentrate for solution for infusion
Sponsors
HECRIN Consortium
Hungarian Ministry of Innovation and Technology
University of Pecs
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
open-label, multi-center, interventional safety study
Eligibility
Sex/Gender
ALL
Age
12 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number and proportion of patients at prespecified in each category | 30 days | Secondary efficacy endpoint - 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 | 30 days | Secondary efficacy endpoint |
| Proportion of participants with normalization of oxygen saturation | 30 days | Secondary efficacy endpoint - proportion of participants with normalization of oxygen saturation (\>=95%) through Day 10 with 14 days follow-up after the last dose |
| Time to recovery (days) | 30 days | Secondary efficacy endpoint |
| Proportion of patients with clinically relevant improvement in radiological findings | 30 days | Exploratory endpoints - Proportion of patients with clinically relevant improvement in radiological findings as assessed by the investigator at discharge from hospital |
| Proportion of patients with COVID19 complications/remaining symptoms | 30 days | Exploratory endpoints - Proportion of patients with COVID19 complications/remaining symptoms as assessed by the investigator at discharge from hospital |
| Proportion of patients with at least one treatment- or intervention-related adverse event | 30 days | Exploratory endpoints |
| Number and proportion of patients | 30 days | Exploratory endpoints - Number and proportion of patients at prespecified timepoints in each category of the 8-point ordinal scale of disease severity. |
| Time to discharge from hospital (days) | 30 days | Secondary efficacy endpoint |
| Number and proportion of patients at prespecified timepoints in each category of the WHO Ordinal Scale for Clinical Improvement | 30 days | Secondary efficacy endpoint |
Countries
Hungary
Outcome results
None listed