REMdesivir-HU Clinical Study and Severe Covid-19 Patients

University of Pecs

Status and phase

Unknown

Phase 3

Conditions

SARS-CoV-2 Infection

Treatments

Drug: Remdesivir-HU

Study type

Interventional

Funder types

Other

Identifiers

NCT04610541

REM-ENY-01

Details and patient eligibility

About

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.

Enrollment

2,000 estimated patients

Sex

All

Ages

12 to 100 years old

Volunteers

No Healthy Volunteers

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.