REMdesivir-HU Clinical Study and Severe Covid-19 Patients

Study Overview
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Brief Summary
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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.

Official Title
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Open-label Study to Assess the Safety of REMdesivir-HU as Eligible Novel therapY for Moderate and Severe Covid-19 Patients

Conditions
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SARS-CoV-2 Infection

Intervention / Treatment
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* Drug: Remdesivir-HU


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: open-label, multi-center, interventional safety study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remdesivir-HU<br>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. | Drug: Remdesivir-HU<br>* Remdesivir-HU 100 mg concentrate for solution for infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of REM use in Hungary in the conditionally approved indication (EMA) | 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). | 30 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2, COVID-19