Clinical trial NCT04610541: REMdesivir-HU Clinical Study and Severe Covid-19 Patients
Official title: Open-label Study to Assess the Safety of REMdesivir-HU as Eligible Novel therapY for Moderate and Severe Covid-19 Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: SARS-CoV-2 Infection
Keywords: SARS-CoV-2, COVID-19
Lead sponsor: University of Pecs
Sponsor class: OTHER
Collaborators: name: HECRIN Consortium
name: Hungarian Ministry of Innovation and Technology
First posted: 2020-10-30
Enrollment: 2000
Sex: ALL
Minimum age (years): 12
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open-label, multi-center, interventional safety study
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: To assess the safety and tolerability of REM use in Hungary in the conditionally approved indication (EMA)
timeFrame: 30 days
Secondary outcomes:
measure: The proportion of patients with at least 1 treatment-emergent adverse event
timeFrame: 30 days
measure: Proportion of patients with treatment-emergent clinical
timeFrame: 30 days
Other outcomes:
measure: Time to recovery (days)
timeFrame: 30 days
measure: Time to discharge from hospital (days)
timeFrame: 30 days
measure: Number and proportion of patients at prespecified timepoints in each category of the WHO Ordinal Scale for Clinical Improvement
timeFrame: 30 days
measure: Number and proportion of patients at prespecified in each category
timeFrame: 30 days
measure: Proportion of participants with normalization of fever
timeFrame: 30 days
measure: Proportion of participants with normalization of oxygen saturation
timeFrame: 30 days
measure: Number and proportion of patients
timeFrame: 30 days
measure: Proportion of patients with clinically relevant improvement in radiological findings
timeFrame: 30 days
measure: Proportion of patients with COVID19 complications/remaining symptoms
timeFrame: 30 days
measure: Proportion of patients with at least one treatment- or intervention-related adverse event
timeFrame: 30 days
Locations:
city: Budapest
country: Hungary
facility: Department of Pulmonology Semmelweis University
city: Budapest
country: Hungary
facility: National Korányi Institute for Pulmonology
city: Budapest
country: Hungary
facility: North - Central Buda Center New St. János Hospital
city: Debrecen
country: Hungary
facility: Institute of Infectology, University of Debrecen
city: Pécs
country: Hungary
facility: 1st Department of Medicine, University of Pécs
city: Szeged
country: Hungary
facility: Department of Internal Medicine University of Szeged
city: Szeged
country: Hungary
facility: First Department of Internal Medicine, University of Szeged
Study officials:
References:
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