REMdesivir-HU Clinical Study and Severe Covid-19 Patients

November 23, 2020 updated by: University of Pecs

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

2000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1083
        • Department of Pulmonology Semmelweis University
      • Budapest, Hungary, 1121
        • National Koranyi Institute for Pulmonology
      • Budapest, Hungary
        • North - Central Buda Center New St. János Hospital
      • Debrecen, Hungary, 4031
        • Institute of Infectology, University of Debrecen
      • Pécs, Hungary, 7624
        • 1st Department of Medicine, University of Pécs
      • Szeged, Hungary, 6720
        • First Department of Internal Medicine, University of Szeged
      • Szeged, Hungary, 6720
        • Department of Internal Medicine University of Szeged

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Remdesivir-HU

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
Remdesivir-HU 100 mg concentrate for solution for infusion

What is the study measuring?

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)
Time Frame: 30 days
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
Time Frame: 30 days
Secondary safety endpoint
30 days
Proportion of patients with treatment-emergent clinical
Time Frame: 30 days
Secondary safety endpoint laboratory abnormalities (separately for the following parameters: ALT, AST, INR, HGB, Bilirubin, ALP, Creatinine, eGFR)
30 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to recovery (days)
Time Frame: 30 days
Secondary efficacy endpoint
30 days
Time to discharge from hospital (days)
Time Frame: 30 days
Secondary efficacy endpoint
30 days
Number and proportion of patients at prespecified timepoints in each category of the WHO Ordinal Scale for Clinical Improvement
Time Frame: 30 days
Secondary efficacy endpoint
30 days
Number and proportion of patients at prespecified in each category
Time Frame: 30 days
Secondary efficacy endpoint - timepoints in each category (Ambient air, Low flow, Medium Flow, High Flow, Non invasive ventilation, Invasive ventilation, ECMO)
30 days
Proportion of participants with normalization of fever
Time Frame: 30 days
Secondary efficacy endpoint
30 days
Proportion of participants with normalization of oxygen saturation
Time Frame: 30 days
Secondary efficacy endpoint - proportion of participants with normalization of oxygen saturation (>=95%) through Day 10 with 14 days follow-up after the last dose
30 days
Number and proportion of patients
Time Frame: 30 days
Exploratory endpoints - Number and proportion of patients at prespecified timepoints in each category of the 8-point ordinal scale of disease severity.
30 days
Proportion of patients with clinically relevant improvement in radiological findings
Time Frame: 30 days
Exploratory endpoints - Proportion of patients with clinically relevant improvement in radiological findings as assessed by the investigator at discharge from hospital
30 days
Proportion of patients with COVID19 complications/remaining symptoms
Time Frame: 30 days
Exploratory endpoints - Proportion of patients with COVID19 complications/remaining symptoms as assessed by the investigator at discharge from hospital
30 days
Proportion of patients with at least one treatment- or intervention-related adverse event
Time Frame: 30 days
Exploratory endpoints
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pecs

Collaborators

Hungarian Ministry of Innovation and Technology
HECRIN Consortium

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2020

Primary Completion (Anticipated)

October 30, 2021

Study Completion (Anticipated)

November 30, 2021

Study Registration Dates

First Submitted

October 11, 2020

First Submitted That Met QC Criteria

October 29, 2020

First Posted (Actual)

October 30, 2020

Study Record Updates

Last Update Posted (Actual)

November 27, 2020

Last Update Submitted That Met QC Criteria

November 23, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REM-ENY-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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