REMdesivir-HU Clinical Study and Severe Covid-19 Patients

• Status: Active, not recruiting
• Trial end date: 2021-11-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pecs
• Collaborators: HECRIN Consortium; Hungarian Ministry of Innovation and Technology
• Treatments: Remdesivir

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.