NCT04610541

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2020

Shorter than P25 for phase_3

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

October 12, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 30, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

November 27, 2020

Status Verified

October 1, 2020

Enrollment Period

1 year

First QC Date

October 11, 2020

Last Update Submit

November 23, 2020

Conditions

SARS-CoV-2 Infection

Keywords

SARS-CoV-2, COVID-19

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • The proportion of patients with at least 1 treatment-emergent adverse event

    30 days

  • Proportion of patients with treatment-emergent clinical

    30 days

Other Outcomes (10)

  • Time to recovery (days)

    30 days

  • Time to discharge from hospital (days)

    30 days

  • Number and proportion of patients at prespecified timepoints in each category of the WHO Ordinal Scale for Clinical Improvement

    30 days

  • +7 more other outcomes

Study Arms (1)

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.

Drug: Remdesivir-HU

Interventions

Remdesivir-HUDRUG

Remdesivir-HU 100 mg concentrate for solution for infusion

Remdesivir-HU

Eligibility Criteria

Age12 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Department of Pulmonology Semmelweis University

Budapest, 1083, Hungary

Location

National Korányi Institute for Pulmonology

Budapest, 1121, Hungary

Location

North - Central Buda Center New St. János Hospital

Budapest, Hungary

Location

Institute of Infectology, University of Debrecen

Debrecen, 4031, Hungary

Location

1st Department of Medicine, University of Pécs

Pécs, 7624, Hungary

Location

Department of Internal Medicine University of Szeged

Szeged, 6720, Hungary

Location

First Department of Internal Medicine, University of Szeged

Szeged, 6720, Hungary

Location

Related Publications (6)

  • 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.

    PMID: 32423584RESULT

  • 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.

    PMID: 32004427RESULT

  • 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.

    PMID: 32224310RESULT

  • 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.

    PMID: 32054787RESULT

  • 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.

    PMID: 28659436RESULT

  • 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.

    PMID: 31924756RESULT

Related Links

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: open-label, multi-center, interventional safety study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2020

First Posted

October 30, 2020

Study Start

October 12, 2020

Primary Completion

October 30, 2021

Study Completion

November 30, 2021

Last Updated

November 27, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

HU(7)