Clinical trail of remdesivir in Covid-19 patinets

Phase 1

• Conditions: SARS-CoV-2 Infection; MedDRA version: 23.0Level: PTClassification code 10084268Term: COVID-19System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-004928-42-HU
• Lead Sponsor: Hungarian Ministry of Innovation and Technology - Representative: Hecrin Consortium

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-12
• Last Update Posted: 19 October 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

oMales or females aged 12yrs and older with body weight at least 40kg
oHospitalized 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
orequiring supplemental oxygen at screening
?at the discretion of the investigator, any form of O2 support can apply
oDo not have access to Veklury treatment
?Patient may be under other treatment against COVID-19 (except for chloroquine/hydroxychloroquine)
oWilling 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)

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 360

Exclusion Criteria

Patients meeting any of the below criteria are not eligible
oKnown liver disease, hepatic impairment and/or Alanine Transaminase (ALT) or Aspartate Transaminase (AST) = 5 times the upper limit of normal
oKnown severe renal disease (including patients receiving hemodialysis or hemofiltration) and/or estimated glomerular filtration rate (eGFR) < 30 ml/min.
oPregnancy or breast feeding at the discretion of the investigator
oAnticipated discharge from the hospital or transfer to another hospital which is not a study site within 120 hours
oOther 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.
oKnow allergy to any anti-viral medication
?Hypersensitivity to the active substance(s) or to any of the excipients
oCurrent (or 48 hours prior) treatment with chloroquine/hydroxychloroquine
oAny medical condition that the examining physician deems unsuitable for the patient to participate in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified