Back to resultsREMdesivir-HU Clinical Study and Severe Covid-19 Patients
Primary Purpose
SARS-CoV-2 Infection
Status
Unknown status
Phase
Phase 3
Locations
Hungary
Study Type
Interventional
Intervention
Remdesivir-HU
Sponsored by
About this trial
This is an interventional treatment trial for SARS-CoV-2 Infection focused on measuring SARS-CoV-2, COVID-19
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.
Sites / Locations
- Department of Pulmonology Semmelweis University
- National Korányi Institute for Pulmonology
- North - Central Buda Center New St. János Hospital
- Institute of Infectology, University of Debrecen
- 1st Department of Medicine, University of Pécs
- Department of Internal Medicine University of Szeged
- First Department of Internal Medicine, University of Szeged
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Remdesivir-HU
Arm Description
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.
Outcomes
Primary Outcome Measures
To assess the safety and tolerability of REM use in Hungary in the conditionally approved indication (EMA)
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
The proportion of patients with at least 1 treatment-emergent adverse event
Secondary safety endpoint
Proportion of patients with treatment-emergent clinical
Secondary safety endpoint laboratory abnormalities (separately for the following parameters: ALT, AST, INR, HGB, Bilirubin, ALP, Creatinine, eGFR)
Full Information
NCT ID
NCT04610541
First Posted
October 11, 2020
Last Updated
November 23, 2020
Sponsor
University of Pecs
Collaborators
HECRIN Consortium, Hungarian Ministry of Innovation and Technology
1. Study Identification
Unique Protocol Identification Number
NCT04610541
Brief Title
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
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 12, 2020 (Actual)
Primary Completion Date
October 30, 2021 (Anticipated)
Study Completion Date
November 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pecs
Collaborators
HECRIN Consortium, Hungarian Ministry of Innovation and Technology
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV-2 Infection
Keywords
SARS-CoV-2, COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
open-label, multi-center, interventional safety study
Masking
None (Open Label)
Allocation
N/A
Enrollment
2000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Remdesivir-HU
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Remdesivir-HU
Intervention Description
Remdesivir-HU 100 mg concentrate for solution for infusion
Primary Outcome Measure Information:
Title
To assess the safety and tolerability of REM use in Hungary in the conditionally approved indication (EMA)
Description
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).
Time Frame
30 days
Secondary Outcome Measure Information:
Title
The proportion of patients with at least 1 treatment-emergent adverse event
Description
Secondary safety endpoint
Time Frame
30 days
Title
Proportion of patients with treatment-emergent clinical
Description
Secondary safety endpoint laboratory abnormalities (separately for the following parameters: ALT, AST, INR, HGB, Bilirubin, ALP, Creatinine, eGFR)
Time Frame
30 days
Other Pre-specified Outcome Measures:
Title
Time to recovery (days)
Description
Secondary efficacy endpoint
Time Frame
30 days
Title
Time to discharge from hospital (days)
Description
Secondary efficacy endpoint
Time Frame
30 days
Title
Number and proportion of patients at prespecified timepoints in each category of the WHO Ordinal Scale for Clinical Improvement
Description
Secondary efficacy endpoint
Time Frame
30 days
Title
Number and proportion of patients at prespecified in each category
Description
Secondary efficacy endpoint - timepoints in each category (Ambient air, Low flow, Medium Flow, High Flow, Non invasive ventilation, Invasive ventilation, ECMO)
Time Frame
30 days
Title
Proportion of participants with normalization of fever
Description
Secondary efficacy endpoint
Time Frame
30 days
Title
Proportion of participants with normalization of oxygen saturation
Description
Secondary efficacy endpoint - proportion of participants with normalization of oxygen saturation (>=95%) through Day 10 with 14 days follow-up after the last dose
Time Frame
30 days
Title
Number and proportion of patients
Description
Exploratory endpoints - Number and proportion of patients at prespecified timepoints in each category of the 8-point ordinal scale of disease severity.
Time Frame
30 days
Title
Proportion of patients with clinically relevant improvement in radiological findings
Description
Exploratory endpoints - Proportion of patients with clinically relevant improvement in radiological findings as assessed by the investigator at discharge from hospital
Time Frame
30 days
Title
Proportion of patients with COVID19 complications/remaining symptoms
Description
Exploratory endpoints - Proportion of patients with COVID19 complications/remaining symptoms as assessed by the investigator at discharge from hospital
Time Frame
30 days
Title
Proportion of patients with at least one treatment- or intervention-related adverse event
Description
Exploratory endpoints
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Department of Pulmonology Semmelweis University
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
National Korányi Institute for Pulmonology
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Facility Name
North - Central Buda Center New St. János Hospital
City
Budapest
Country
Hungary
Facility Name
Institute of Infectology, University of Debrecen
City
Debrecen
ZIP/Postal Code
4031
Country
Hungary
Facility Name
1st Department of Medicine, University of Pécs
City
Pécs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Department of Internal Medicine University of Szeged
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
First Department of Internal Medicine, University of Szeged
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32423584
Citation
Wang Y, Zhang D, Du G, Du R, Zhao J, Jin Y, Fu S, Gao L, Cheng Z, Lu Q, Hu Y, Luo G, Wang K, Lu Y, Li H, Wang S, Ruan S, Yang C, Mei C, Wang Y, Ding D, Wu F, Tang X, Ye X, Ye Y, Liu B, Yang J, Yin W, Wang A, Fan G, Zhou F, Liu Z, Gu X, Xu J, Shang L, Zhang Y, Cao L, Guo T, Wan Y, Qin H, Jiang Y, Jaki T, Hayden FG, Horby PW, Cao B, Wang C. Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial. Lancet. 2020 May 16;395(10236):1569-1578. doi: 10.1016/S0140-6736(20)31022-9. Epub 2020 Apr 29. Erratum In: Lancet. 2020 May 30;395(10238):1694.
Results Reference
result
PubMed Identifier
32004427
Citation
Holshue ML, DeBolt C, Lindquist S, Lofy KH, Wiesman J, Bruce H, Spitters C, Ericson K, Wilkerson S, Tural A, Diaz G, Cohn A, Fox L, Patel A, Gerber SI, Kim L, Tong S, Lu X, Lindstrom S, Pallansch MA, Weldon WC, Biggs HM, Uyeki TM, Pillai SK; Washington State 2019-nCoV Case Investigation Team. First Case of 2019 Novel Coronavirus in the United States. N Engl J Med. 2020 Mar 5;382(10):929-936. doi: 10.1056/NEJMoa2001191. Epub 2020 Jan 31.
Results Reference
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PubMed Identifier
32224310
Citation
Lescure FX, Bouadma L, Nguyen D, Parisey M, Wicky PH, Behillil S, Gaymard A, Bouscambert-Duchamp M, Donati F, Le Hingrat Q, Enouf V, Houhou-Fidouh N, Valette M, Mailles A, Lucet JC, Mentre F, Duval X, Descamps D, Malvy D, Timsit JF, Lina B, van-der-Werf S, Yazdanpanah Y. Clinical and virological data of the first cases of COVID-19 in Europe: a case series. Lancet Infect Dis. 2020 Jun;20(6):697-706. doi: 10.1016/S1473-3099(20)30200-0. Epub 2020 Mar 27. Erratum In: Lancet Infect Dis. 2020 May 19;: Lancet Infect Dis. 2020 Jun;20(6):e116.
Results Reference
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PubMed Identifier
32054787
Citation
de Wit E, Feldmann F, Cronin J, Jordan R, Okumura A, Thomas T, Scott D, Cihlar T, Feldmann H. Prophylactic and therapeutic remdesivir (GS-5734) treatment in the rhesus macaque model of MERS-CoV infection. Proc Natl Acad Sci U S A. 2020 Mar 24;117(12):6771-6776. doi: 10.1073/pnas.1922083117. Epub 2020 Feb 13.
Results Reference
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Citation
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Results Reference
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Citation
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Links:
URL
https://www.who.int/news-room/detail
Description
World Health Organization (WHO) 2020
URL
https://www.medrxiv.org/content/10.1101/2020.03.09.20032896v1
Description
Kujawski et al., First 12 patients with coronavirus disease 2019 (COVID-19) in the United States,
URL
https://www.ema.europa.eu/en
Description
European Medicines Agency - Velury
URL
https://www.ema.europa.eu/en
Description
COVID-19 Therapeutic Trial Synopsis, Draft February 18, 2020
Learn more about this trial
REMdesivir-HU Clinical Study and Severe Covid-19 Patients
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