REMdesivir-HU Clinical Study and Severe Covid-19 Patients

SARS-CoV-2 Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04610541
• Other study ID #: REM-ENY-01
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 12, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: October 2020
• Source: University of Pecs
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. completion date: November 30, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• SARS-CoV-2 Infection

Intervention

Drug:
• Remdesivir-HU
Remdesivir-HU 100 mg concentrate for solution for infusion

Locations

Country	Name	City	State
Hungary	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

Sponsors (3)

Lead Sponsor	Collaborator
University of Pecs	HECRIN Consortium, Hungarian Ministry of Innovation and Technology

Country where clinical trial is conducted

Hungary, 

References & Publications (6)

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 — View 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 St — View 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 — View Citation

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- — View Citation

Sheahan TP, Sims AC, Leist SR, Schäfer 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 combinati — View 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, Zhan — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to recovery (days)	Secondary efficacy endpoint	30 days
Other	Time to discharge from hospital (days)	Secondary efficacy endpoint	30 days
Other	Number and proportion of patients at prespecified timepoints in each category of the WHO Ordinal Scale for Clinical Improvement	Secondary efficacy endpoint	30 days
Other	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
Other	Proportion of participants with normalization of fever	Secondary efficacy endpoint	30 days
Other	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
Other	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
Other	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
Other	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
Other	Proportion of patients with at least one treatment- or intervention-related adverse event	Exploratory endpoints	30 days
Primary	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
Secondary	The proportion of patients with at least 1 treatment-emergent adverse event	Secondary safety endpoint	30 days
Secondary	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)	30 days

External Links

•   Beigel et al., Remdesivir for the Treatment of Covid-19 - Final Report,
•   COVID-19 Therapeutic Trial Synopsis, Draft February 18, 2020
•   European Medicines Agency - Velury
•   Goldman et al., Remdesivir for 5 or 10 Days in Patients with Severe Covid-19
•   Holshue et al., First Case of 2019 Novel Coronavirus in the United States
•   Kujawski et al., First 12 patients with coronavirus disease 2019 (COVID-19) in the United States,
•   Mulangu et al., A Randomized, Controlled Trial of Ebola Virus Disease Therapeutics,
•   World Health Organization (WHO) 2020