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REMdesivir-HU Clinical Study and Severe Covid-19 Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04610541
Recruitment Status : Active, not recruiting
First Posted : October 30, 2020
Last Update Posted : November 27, 2020
Sponsor:
Collaborators:
HECRIN Consortium
Hungarian Ministry of Innovation and Technology
Information provided by (Responsible Party):
University of Pecs

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.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Infection Drug: Remdesivir-HU Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: open-label, multi-center, interventional safety study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label Study to Assess the Safety of REMdesivir-HU as Eligible Novel therapY for Moderate and Severe Covid-19 Patients
Actual Study Start Date : October 12, 2020
Estimated Primary Completion Date : October 30, 2021
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. The proportion of patients with at least 1 treatment-emergent adverse event [ Time Frame: 30 days ]
    Secondary safety endpoint

  2. 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)


Other Outcome Measures:
  1. Time to recovery (days) [ Time Frame: 30 days ]
    Secondary efficacy endpoint

  2. Time to discharge from hospital (days) [ Time Frame: 30 days ]
    Secondary efficacy endpoint

  3. 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

  4. 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)

  5. Proportion of participants with normalization of fever [ Time Frame: 30 days ]
    Secondary efficacy endpoint

  6. 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

  7. 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.

  8. 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

  9. 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

  10. Proportion of patients with at least one treatment- or intervention-related adverse event [ Time Frame: 30 days ]
    Exploratory endpoints



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04610541


Locations
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Hungary
Department of Pulmonology Semmelweis University
Budapest, Hungary, 1083
National Korányi Institute for Pulmonology
Budapest, Hungary, 1121
North - Central Buda Center New St. János Hospital
Budapest, Hungary
Institute of Infectology, University of Debrecen
Debrecen, Hungary, 4031
1st Department of Medicine, University of Pécs
Pécs, Hungary, 7624
Department of Internal Medicine University of Szeged
Szeged, Hungary, 6720
First Department of Internal Medicine, University of Szeged
Szeged, Hungary, 6720
Sponsors and Collaborators
University of Pecs
HECRIN Consortium
Hungarian Ministry of Innovation and Technology
Additional Information:
Publications of Results:

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Responsible Party: University of Pecs
ClinicalTrials.gov Identifier: NCT04610541    
Other Study ID Numbers: REM-ENY-01
First Posted: October 30, 2020    Key Record Dates
Last Update Posted: November 27, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by University of Pecs:
SARS-CoV-2, COVID-19
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Remdesivir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents