This is a placebo-controlled, randomized, double-blind study to evaluate the pharmacokinetics, safety and antiviral activity of galidesivir in subjects with yellow fever (YF) or COVID-19.
This is a randomized, double-blind, placebo-controlled study to evaluate the pharmacokinetics (PK), safety, and antiviral effects of galidesivir administered via intravenous (IV) infusion vs. placebo in hospitalized adult subjects with either Yellow Fever (Group A) or COVID-19 (Group B). The study will be conducted in two parts, and each Group (A or B) will proceed independently through the study. Part 1 is a dose ranging study with three sequential cohorts of eight patients each that will be randomized 3:1 to receive IV galidesivir or placebo every 12 hours for 7 days. Upon completion of part 1, an optimized dosing regimen of galidesivir will be selected for part 2, based on part 1 results including safety, PK, viral load reduction, and improvement in signs and symptoms and clinical manifestations, and mortality. In part 2, up to 42 patients will be randomized 2:1 to receive IV galidesivir or placebo. After treatment, the patients will remain hospitalized until resolution of symptoms allows release. All patients will be followed for mortality through Day 56.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
Galidesivir IV infusion
Placebo IV infusion
Hospital de Clinicas da Universidade Federal do Parana
Curitiba, Paraná, Brazil
Hospital Sao Vicente de Paulo-PPDS
Passo Fundo, Rio Grande do Sul, Brazil
Hospital Sao Lucas da Pucrs
Porto Alegre, Rio Grande do Sul, Brazil
Foundation Regional Faculty of Medicine of São José do Rio Preto
São José do Rio Preto, São Paulo, Brazil
number of subjects with treatment emergent adverse events and serious adverse events
Time frame: absolute number through the end of the study, approximately 56 days
number of subjects with change in laboratory parameters
Time frame: absolute number and change from baseline through the end of the study, approximately 56 days
exposure of galidesivir as measured by plasma concentrations
Time frame: 24 hours post dose on Day 1 through 12 hours post dose on Day 7
yellow fever virus (YFV) titer (Group A)
Time frame: change in YFV titer from baseline through Day 21
antiviral effect on SARS-CoV-2 in the respiratory tract - COVID-19 (Group B)
Time frame: change in SARS-CoV-2 from baseline through Day 21
changes in clinical status using 8-point ordinal scale in COVID-19 (Group B)
Time frame: through Day 21
changes from baseline and time to improvement using NEWS in COVID-19 (Group B)
Time frame: through Day21
mortality
Time frame: mortality at Day 56
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Clinical Research Unit and Department of Infectious and Parasitic Diseases Hospital das Clínicas, School of Medicine, USP
São Paulo, São Paulo, Brazil