REMdesivir-HU Clinical Study and Severe Covid-19 Patients
NCT ID: NCT04610541
Last Updated: 2020-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
2000 participants
INTERVENTIONAL
2020-10-12
2021-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Remdesivir-HU
Remdesivir-HU 100 mg concentrate for solution for infusion
Interventions
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Remdesivir-HU
Remdesivir-HU 100 mg concentrate for solution for infusion
Eligibility Criteria
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Inclusion Criteria
* 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 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.
12 Years
100 Years
ALL
No
Sponsors
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HECRIN Consortium
UNKNOWN
Hungarian Ministry of Innovation and Technology
UNKNOWN
University of Pecs
OTHER
Responsible Party
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Locations
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Department of Pulmonology Semmelweis University
Budapest, , Hungary
National Korányi Institute for Pulmonology
Budapest, , Hungary
North - Central Buda Center New St. János Hospital
Budapest, , Hungary
Institute of Infectology, University of Debrecen
Debrecen, , Hungary
1st Department of Medicine, University of Pécs
Pécs, , Hungary
Department of Internal Medicine University of Szeged
Szeged, , Hungary
First Department of Internal Medicine, University of Szeged
Szeged, , Hungary
Countries
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References
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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.
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.
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.
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.
Sheahan TP, Sims AC, Graham RL, Menachery VD, Gralinski LE, Case JB, Leist SR, Pyrc K, Feng JY, Trantcheva I, Bannister R, Park Y, Babusis D, Clarke MO, Mackman RL, Spahn JE, Palmiotti CA, Siegel D, Ray AS, Cihlar T, Jordan R, Denison MR, Baric RS. Broad-spectrum antiviral GS-5734 inhibits both epidemic and zoonotic coronaviruses. Sci Transl Med. 2017 Jun 28;9(396):eaal3653. doi: 10.1126/scitranslmed.aal3653.
Sheahan TP, Sims AC, Leist SR, Schafer A, Won J, Brown AJ, Montgomery SA, Hogg A, Babusis D, Clarke MO, Spahn JE, Bauer L, Sellers S, Porter D, Feng JY, Cihlar T, Jordan R, Denison MR, Baric RS. Comparative therapeutic efficacy of remdesivir and combination lopinavir, ritonavir, and interferon beta against MERS-CoV. Nat Commun. 2020 Jan 10;11(1):222. doi: 10.1038/s41467-019-13940-6.
Related Links
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World Health Organization (WHO) 2020
Kujawski et al., First 12 patients with coronavirus disease 2019 (COVID-19) in the United States,
Beigel et al., Remdesivir for the Treatment of Covid-19 - Final Report,
European Medicines Agency - Velury
COVID-19 Therapeutic Trial Synopsis, Draft February 18, 2020
Other Identifiers
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REM-ENY-01
Identifier Type: -
Identifier Source: org_study_id