Clinical trial NCT04745351: Study to Evaluate the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for Coronavirus Disease 2019 (COVID-19)
Official title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study Evaluating the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for COVID-19
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: COVID-19
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2021-02-09
Enrollment: 249
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate whether remdesivir (RDV, GS-5734™) reduces the composite risk of death or invasive mechanical ventilation (IMV) through Day 29 in participants with severely reduced kidney function who are hospitalized for coronavirus disease 2019 (COVID-19).


Eligibility criteria: Key Inclusion Criteria:

* Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) positive as determined by Polymerase Chain Reaction (PCR) or other commercially available or public health assay (eg, Nucleic Acid Amplification Test (NAAT) and antigen tests) in any respiratory specimen
* Hospitalized for COVID-19
* Weighing at least 40 kilograms (kg)
* Oxygen (O2) saturation ≤ 94% on room air or requiring O2 supplement or Radiographic evidence of pulmonary infiltrates for COVID-19
* Have either:

  * a) Severely reduced kidney function (estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min/1.73 m\^2), including people with end-stage kidney disease (ESKD) requiring chronic dialysis
  * b) Ongoing acute kidney injury (AKI): defined as a 50% increase in serum creatinine (SCr) within a 48-hour period that is sustained (ie, requires confirmatory SCr) for ≥ 6 hours despite supportive care
* The interval between COVID-19 symptoms onset and randomization is no more than 10 days

Key Exclusion Criteria:

* Received any investigational drug, RDV, or other antiviral treatment for COVID-19
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 times the upper limit of normal
* Invasive mechanical ventilation, noninvasive mechanical ventilation, extracorporeal membrane oxygenation (ECMO), or renal replacement therapy (RRT) for acute kidney injury (AKI)
* Positive serum pregnancy test at screening for women of childbearing potential or currently breastfeeding
* Known hypersensitivity to the study drug, metabolites, or formulation sulfobutylether-beta-cyclodextrin (SBECD)

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Primary outcomes:
measure: Percentage of Participants With All-cause Death or Invasive Mechanical Ventilation (IMV) Through Day 29
timeFrame: First dose date up to Day 29
Secondary outcomes:
measure: All-cause Mortality Through Day 29
timeFrame: First dose date up to Day 29
measure: Percentage of Participants With Initiation of IMV Through Day 29
timeFrame: First dose date up to Day 29
measure: Time to Recovery Without Subsequent Worsening (Defined as an Ordinal Scale Score of > 4) by Day 29
timeFrame: First dose date up to Day 29
measure: Time to Recovery Independent of Further Worsening by Day 29
timeFrame: First dose date up to Day 29
measure: Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 15
timeFrame: Day 15
measure: Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 29
timeFrame: Day 29
measure: Renal Replacement Therapy (RRT)-Free Days (Among Those Without End-Stage Kidney Disease [ESKD] at Baseline) Through Day 29
timeFrame: First dose date up to Day 29
measure: Percentage of Participants With Recovery Without Subsequent Worsening (Defined as an Ordinal Scale Score of > 4) Through Day 29
timeFrame: First dose date up to Day 29
measure: Percentage of Participants With Recovery Independent of Further Worsening Through Day 29
timeFrame: First dose date up to Day 29
measure: Percentage of Participants Experiencing Serious Adverse Events (SAEs)
timeFrame: First dose date up to last dose date (Maximum: 5 days) plus 30 days
measure: Percentage of Participants Who Permanently Discontinued Investigational Drug Due to Adverse Events (AEs)
timeFrame: First dose date up to last dose date (Maximum: 5 days)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: St. Vincent's Health System
state: Alabama
city: Birmingham
country: United States
facility: UAB Hospital
state: Alabama
city: Mobile
country: United States
facility: Pulmonary Associates of Mobile, P.C.
state: Alabama
city: Eureka
country: United States
facility: St. Joseph Hospital Eureka
state: California
city: Irvine
country: United States
facility: Hoag Memorial Hospital Presbyterian, 16200 Sand Canyon Ave
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Sacramento
country: United States
facility: Sutter Medical Center Sacramento
state: California
city: Torrance
country: United States
facility: Torrance Memorial Medical Center
state: California
city: Washington
country: United States
facility: MedStar Health Research Institute
state: District of Columbia
city: Washington
country: United States
facility: George Washington Medical Faculty Associates
state: District of Columbia
city: Gainesville
country: United States
facility: North Florida/ South Georgia Veterans Health System
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Tampa
country: United States
facility: Genesis Clinical Research
state: Florida
city: Winfield
country: United States
facility: Northwestern Medicine Central DuPage Hospital
state: Illinois
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: New Orleans
country: United States
facility: Tulane Medical Center, 2000 Canal St.
state: Louisiana
city: New Orleans
country: United States
facility: Tulane Medical Center
state: Louisiana
city: Bethesda
country: United States
facility: Wake Forest University Health Sciences
state: Maryland
city: Germantown
country: United States
facility: Holy Cross Hospital, 19801 Observation Dr
state: Maryland
city: Silver Spring
country: United States
facility: Holy Cross Hospital
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Newton
country: United States
facility: Newton-Wellesley Hospital
state: Massachusetts
city: Grosse Pointe Woods
country: United States
facility: St. Clair Nephrology Research
state: Michigan
city: Jackson
country: United States
facility: G.V. (Sonny) Montgomery VAMC
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Hospital
state: Minnesota
city: Newark
country: United States
facility: Saint Michael's Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico Hospital
state: New Mexico
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: New York
country: United States
facility: New York - Presbyterian Hospital/Weill Cornell Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
city: Portland
country: United States
facility: PMG Infectious Disease Consultants (administrative)
state: Oregon
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Hospital at TMC
state: Texas
city: Richmond
country: United States
facility: VCU Health Medical Center
state: Virginia
city: Everett
country: United States
facility: Providence Regional Medical Center Everett
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Spokane
country: United States
facility: Providence Health Care
state: Washington
city: Spokane
country: United States
facility: Providence Health Care, 5633 N Lidgerwood
state: Washington
city: Tacoma
country: United States
facility: MultiCare Good Samaritan Hospital
state: Washington
city: Campinas
country: Brazil
facility: Hospital e Maternidade Celso Pierro/ Sociedade Campineira de Educacao e Instrucao/ PUC Campinas
city: Curitiba
country: Brazil
facility: Hospital Nossa Senhora das Gracas
city: Sao Paulo
country: Brazil
facility: Hospital Alemao Oswaldo Cruz
city: São José do Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
city: Covilhã
country: Portugal
facility: Centro Hospitalar Cova da Beira EPE
city: Funchal
country: Portugal
facility: Hospital Nélio Mendonça,
city: Lisbon
country: Portugal
facility: Centro Hospitalar Lisboa Ocidental
city: Odivelas
country: Portugal
facility: Centro Hospitalar do Porto - Hospital de Santo Antonio
city: Vila Nova de Gaia
country: Portugal
facility: Centro Hospitalar de Vila Nova de Gaia
city: George
country: South Africa
facility: George Regional Hospital
city: Somerset West
country: South Africa
facility: Mediclinic Vergelegen
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias I Pujol
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Salamanca
country: Spain
facility: Complejo Asistencial Universitario de Salamanca - H. Clinico
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: London
country: United Kingdom
facility: Barts Health NHS Trust, The Royal London Hospital
city: London
country: United Kingdom
facility: Kings College Hospital
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: