Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04323761




Registration number
NCT04323761
Ethics application status
Date submitted
24/03/2020
Date registered
27/03/2020
Date last updated
13/11/2020

Titles & IDs
Public title
Expanded Access Treatment Protocol: Remdesivir (RDV; GS-5734) for the Treatment of SARS-CoV2 (CoV) Infection (COVID-19)
Scientific title
Expanded Access Treatment Protocol: Remdesivir (RDV; GS-5734) for the Treatment of SARS-CoV2 (CoV) Infection
Secondary ID [1] 0 0
2020-001453-49
Secondary ID [2] 0 0
GS-US-540-5821
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
SARS-CoV2 Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Expanded Access
Description of intervention(s) / exposure
Treatment: Drugs - Remdesivir

Treatment: Drugs: Remdesivir
Intravenous infusion administered over a 30 to 120 minute period
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
* Willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under International Conference on Harmonization (ICH) E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (participants = 18 years of age), or willing and able to provide assent (participants = 12 and < 18 years of age, where locally and nationally approved) prior to performing study procedures. For participants = 12 and < 18 years of age, a parent or legal guardian willing and able to provide written informed consent prior to performing study procedures.
* Age = 18 years or aged = 12 and < 18 years of age weighing = 40 kg (where permitted according to local law and approved nationally and by the relevant institutional review board (IRB) or independent ethics committee (IEC))
* Hospitalized with confirmed SARS-CoV2 by polymerase chain reaction (PCR) or known contact of confirmed case with syndrome consistent with coronavirus disease (COVID-19) with PCR pending
* Oxygen saturation (SpO2) = 94% on room air or requiring supplemental oxygen at baseline
* Alanine aminotransferase (ALT) < 5 x upper limit of normal (ULN) by local laboratory measure and/or ALT < 3 x ULN and bilirubin < 2 x ULN
* Females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
* Lactating females must agree to discontinue nursing before the study drug is administered and while they are participating in the study
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Evidence of multiorgan failure including but not limited to coagulopathy (significant thrombocytopenia), hepatic failure (elevated bilirubin) or renal failure (low urine output or estimated glomerular filtration rate (eGFR) < 30 mL/min), or significant cardiomyopathy (low cardiac output)
* Use of more than 1 pressor for septic shock (note that use of 1 pressor at low/medium doses for inotropic support due to the use of sedation and paralytics while on the ventilator is allowed)
* Renal failure (eGRF < 30 mL/min using the Cockcroft-Gault formula for participants = 18 years of age and Schwartz Formula for participants < 18 years of age) or dialysis or continuous Veno-Venous Hemofiltration)
* Eligible for enrollment in a randomized clinical trial studying remdesivir for treatment of SARS-CoV2 at the medical facility where the participant is admitted
* Known hypersensitivity to the study drug, the metabolites, or formulation excipient
* Requiring venous arterial (V-A) extracorporeal membrane oxygen (ECMO) (venous venous (V-V) ECMO is not an exclusion criteria)

Study design
Purpose of the study
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
APPROVED_FOR_MARKETING
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
St. Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [3] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [4] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment hospital [5] 0 0
Gold Coast Hospital - Southport
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment postcode(s) [5] 0 0
4215 - Southport
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Connecticut
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Louisiana
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United States of America
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Maryland
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Massachusetts
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United States of America
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Michigan
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United States of America
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Mississippi
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United States of America
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Missouri
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New Jersey
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United States of America
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New York
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North Carolina
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United States of America
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Ohio
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United States of America
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Oklahoma
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United States of America
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Pennsylvania
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United States of America
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Rhode Island
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South Carolina
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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United States of America
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Wisconsin
Country [31] 0 0
Austria
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Graz
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Austria
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Innsbruck
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Austria
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Linz
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Austria
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Vienna
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Austria
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Wien
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Belgium
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Brussels
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Belgium
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Ghent
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Belgium
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Hasselt
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Belgium
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Kortrijk
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Belgium
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Leuven
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Belgium
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Liège
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Belgium
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Lodelinsart
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Canada
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Ontario
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Cyprus
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Nicosia
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Czechia
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Prague
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Czechia
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Praha 5
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Czechia
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Praha 8 - Liben
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Denmark
State/province [48] 0 0
Copenhagen
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Estonia
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Tallinn
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Estonia
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Tartu
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France
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Bobigny
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France
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Brest Cedex
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France
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Clermont Ferrand
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France
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Colmar
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France
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Corbeil Essonnes
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France
State/province [56] 0 0
Garches
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France
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Orléans
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France
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Poitiers
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France
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Rouen
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France
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Toulouse
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Germany
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Bochum
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Germany
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Dresden
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Germany
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Essen
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Germany
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Freiburg
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Germany
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Göttingen
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Germany
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Hannover
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Germany
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Heidelberg
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Germany
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Homburg
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Germany
State/province [69] 0 0
Regensburg
Country [70] 0 0
Germany
State/province [70] 0 0
Würzburg
Country [71] 0 0
Greece
State/province [71] 0 0
Patra
Country [72] 0 0
Greece
State/province [72] 0 0
Thessaloniki
Country [73] 0 0
Hungary
State/province [73] 0 0
Debrecen
Country [74] 0 0
Iceland
State/province [74] 0 0
Reykjavik
Country [75] 0 0
Ireland
State/province [75] 0 0
Tralee
Country [76] 0 0
Israel
State/province [76] 0 0
Jerusalem
Country [77] 0 0
Israel
State/province [77] 0 0
Petah Tikva
Country [78] 0 0
Israel
State/province [78] 0 0
Ramat Gan
Country [79] 0 0
Italy
State/province [79] 0 0
Ancona
Country [80] 0 0
Italy
State/province [80] 0 0
Bari
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Italy
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Bologna
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Italy
State/province [82] 0 0
Brescia
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Italy
State/province [83] 0 0
Catania
Country [84] 0 0
Italy
State/province [84] 0 0
Florence
Country [85] 0 0
Italy
State/province [85] 0 0
Genova
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Italy
State/province [86] 0 0
Milano
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Italy
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Monza
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Italy
State/province [88] 0 0
Napoli
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Italy
State/province [89] 0 0
Pisa
Country [90] 0 0
Italy
State/province [90] 0 0
Roma
Country [91] 0 0
Italy
State/province [91] 0 0
Turin
Country [92] 0 0
Lithuania
State/province [92] 0 0
Kaunas
Country [93] 0 0
Lithuania
State/province [93] 0 0
Vilnius
Country [94] 0 0
Netherlands
State/province [94] 0 0
Nijmegen
Country [95] 0 0
Netherlands
State/province [95] 0 0
The Hague
Country [96] 0 0
Poland
State/province [96] 0 0
Krakow
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Poland
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Lodz
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Poland
State/province [98] 0 0
Poznan
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Poland
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Tychy
Country [100] 0 0
Portugal
State/province [100] 0 0
Lisboa
Country [101] 0 0
Portugal
State/province [101] 0 0
Porto
Country [102] 0 0
Portugal
State/province [102] 0 0
Vila Nova de Gaia
Country [103] 0 0
Romania
State/province [103] 0 0
Bucharest
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Romania
State/province [104] 0 0
Iasi
Country [105] 0 0
Romania
State/province [105] 0 0
Timisoara
Country [106] 0 0
Slovakia
State/province [106] 0 0
Košice
Country [107] 0 0
Slovenia
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Ljubljana
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Slovenia
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Maribor
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Spain
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Badalona
Country [110] 0 0
Spain
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Madrid
Country [111] 0 0
Spain
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Oviedo
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Spain
State/province [112] 0 0
Palma de Mallorca
Country [113] 0 0
Spain
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Salamanca
Country [114] 0 0
Spain
State/province [114] 0 0
San Sebastian
Country [115] 0 0
Spain
State/province [115] 0 0
Santa Cruz de Tenerife
Country [116] 0 0
Spain
State/province [116] 0 0
Toledo
Country [117] 0 0
Spain
State/province [117] 0 0
Valladolid
Country [118] 0 0
Spain
State/province [118] 0 0
Zaragoza
Country [119] 0 0
Switzerland
State/province [119] 0 0
Aarau
Country [120] 0 0
Switzerland
State/province [120] 0 0
Basel
Country [121] 0 0
Switzerland
State/province [121] 0 0
Biel
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Switzerland
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Chur
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Switzerland
State/province [123] 0 0
Lausanne
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Switzerland
State/province [124] 0 0
Luzern
Country [125] 0 0
Switzerland
State/province [125] 0 0
Sion
Country [126] 0 0
United Kingdom
State/province [126] 0 0
Cardiff
Country [127] 0 0
United Kingdom
State/province [127] 0 0
London
Country [128] 0 0
United Kingdom
State/province [128] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04323761