A Phase 3 Study of Remdesivir in Participants with Severe Renal Impairment who are in Hospital for COVID-19
- Conditions
- Coronavirus disease 2019 (COVID-19) in patients with chronic renal impairmentMedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-005416-22-PT
- Lead Sponsor
- Gilead Sciences Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 249
Participants must meet all of the following inclusion criteria to be eligible for participation in this study:
1) SARS-CoV-2 positive as determined by polymerase chain reaction (PCR) or other commercially available or public health assay (eg, nucleic acid amplification test and antigen tests) in any respiratory specimen
2) Hospitalized for COVID-19
3) Age = 12 years and weighing at least 40 kg
4) O2 saturation = 94% on room air or requiring O2 supplementation OR radiographic evidence of pulmonary infiltrates for COVID-19
5) Have either:
a) Severely reduced kidney function (eGFR < 30 mL/min/1.73 m2), using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and revised Schwartz equations for adults and adolescents, respectively, including people with ESKD requiring chronic dialysis but not people requiring RRT for AKI {Levey 2009, Schwartz 2009} Adults: eGFR (mL/min/1.73 m²) 141 × min(Scr/?, 1)a × max(Scr/?, 1)-1.209 × 0.993Age × 1.018 [if female] × 1.159 [if African American]
? = 0.7 for females; 0.9 for males
a = -0.329 for females; -0.411 for males
Adolescents (age 12–17 years): eGFR (mL/min/1.73 m²) = (0.41 × Height in cm) / Scr
SCr in mg/dL, age in years (See Appendix 7 of Protocol for web links to adult and adolescent eGFR calculators), OR
b) Ongoing AKI: defined as a 50% increase in SCr within a 48-hour period that is sustained (ie, requires confirmatory SCr) for = 6 hours despite supportive care
6) Willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under International Council for Harmonisation (of Technical Requirements for Pharmaceuticals for Human Use) (ICH) E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (age =18) prior to performing study procedures
7) The interval between COVID-19 symptoms onset and randomization is no more than 10 days
8) Male participants and female participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described in Appendix 4 of the Protocol
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 533
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 533
Participants who meet any of the following exclusion criteria at screening and randomization are not eligible to be enrolled in this study:
1) Received any investigational drug, RDV, or other antiviral treatment for COVID-19
2) ALT or AST > 5 × ULN
3) Invasive mechanical ventilation, noninvasive mechanical ventilation, ECMO, or RRT for AKI
4) Positive serum pregnancy test at screening for women of childbearing potential or currently breastfeeding
5) Known hypersensitivity to the investigational drug, metabolites, or formulation SBECD
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method