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| Name | Class |
|---|---|
| HECRIN Consortium | UNKNOWN |
| Hungarian Ministry of Innovation and Technology | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remdesivir-HU | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remdesivir-HU | Drug | Remdesivir-HU 100 mg concentrate for solution for infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with at least 1 treatment-emergent adverse event | Secondary safety endpoint | 30 days |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to recovery (days) | Secondary efficacy endpoint | 30 days |
| Time to discharge from hospital (days) | Secondary efficacy endpoint | 30 days |
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pulmonology Semmelweis University | Budapest | 1083 | Hungary | |||
| National Korányi Institute for Pulmonology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32423584 | Result | 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. | |
| 32004427 |
| Label | URL |
|---|---|
| World Health Organization (WHO) 2020 | View source |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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open-label, multi-center, interventional safety study
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| 30 days |
| Number and proportion of patients at prespecified timepoints in each category of the WHO Ordinal Scale for Clinical Improvement | Secondary efficacy endpoint | 30 days |
| Number and proportion of patients at prespecified in each category | 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 | Secondary efficacy endpoint | 30 days |
| Proportion of participants with normalization of oxygen saturation | 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 | 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 | 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 | 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 | Exploratory endpoints | 30 days |
| Budapest |
| 1121 |
| Hungary |
| North - Central Buda Center New St. János Hospital | Budapest | Hungary |
| Institute of Infectology, University of Debrecen | Debrecen | 4031 | Hungary |
| 1st Department of Medicine, University of Pécs | Pécs | 7624 | Hungary |
| Department of Internal Medicine University of Szeged | Szeged | 6720 | Hungary |
| First Department of Internal Medicine, University of Szeged | Szeged | 6720 | Hungary |
| Result |
| 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. |
| 32224310 | Result | 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. |
| 32054787 | Result | 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. |
| 28659436 | Result | 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. |
| 31924756 | Result | 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. |
| Kujawski et al., First 12 patients with coronavirus disease 2019 (COVID-19) in the United States, | View source |
| Beigel et al., Remdesivir for the Treatment of Covid-19 - Final Report, | View source |
| Mulangu et al., A Randomized, Controlled Trial of Ebola Virus Disease Therapeutics, | View source |
| European Medicines Agency - Velury | View source |
| COVID-19 Therapeutic Trial Synopsis, Draft February 18, 2020 | View source |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |