Randomized, placebo-controlled study to evaluate the safety, pharmacokinetics and efficacy of a single dose of STI-1499 (COVI-GUARD™) in hospitalized patients with moderate COVID-19
This study is a randomized, double-blind, placebo-controlled study to evaluate the safety, pharmacokinetics and efficacy of a single dose of STI-1499 (COVI-GUARD™), a COVID-19 targeting monoclonal antibody, in hospitalized patients with moderate COVID-19. Four dose levels will be tested: 10 mg, 30 mg, 100 mg, and 200 mg.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
COVI-GUARD (STI-1499) is a monoclonal antibody which targets the COVID-19 spike protein
Standard of Care as determined by the Investigator
Diluent
Incidence of adverse events (safety)
Types, frequencies, and severities of adverse events and their relationships to COVI-GUARD
Time frame: Randomization through study completion through Day 60
Incidence of treatment-emergent adverse events (safety)
Types, frequencies, and severities of treatment-emergent adverse events and their relationships to COVI-GUARD
Time frame: Randomization through study completion through Day 60
Incidence of serious adverse events (safety)
Types, frequencies, and severities of serious adverse events and their relationships to COVI-GUARD
Time frame: Randomization through study completion through Day 60
All-cause mortality at 29 and 60 days
All-cause mortality at 29 and 60 days
Time frame: Randomization through Day 29 and Day 60
Incidence of dose-limiting toxicities (safety)
Dose-limiting toxicities, particularly presence of acute or delayed hypersensitivity reactions
Time frame: Randomization through study completion through Day 60
Incidence of laboratory abnormalities (safety)
Clinically meaningful laboratory abnormalities
Time frame: Randomization through study completion through Day 60
SARS-CoV-2 viral load as assessed using various sample types
Plasma samples and salivary samples are taken to correlate viral load with nasopharyngeal testing at various timepoints; stool or rectal swab samples are taken if possible for additional virologic assessments
Time frame: Randomization through study completion through Day 60
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Time to hospitalization, treatment, ICU admission, and discharge from ICU and/or hospital
Time from onset of COVID-19 symptoms to hospitalization and to treatment on Day 1, and if applicable, time to ICU admission, discharge from ICU and discharge from hospital
Time frame: Randomization up to study completion through Day 60
Anti-drug antibodies
Presence and levels of anti-drug antibodies (ADA) directed to COVI-GUARD
Time frame: Randomization through study completion through Day 60
Cytokine levels
Levels of cytokines including EGF, IFNγ, IL-1β, IL-6, IL-8, IL-10, and TNFα
Time frame: Randomization through study completion through Day 60
AUC of COVI-GUARD (PK)
Area under the serum concentration-time curve (AUC) of COVI-GUARD
Time frame: Randomization through study completion through Day 60
Cmax of COVI-GUARD (PK)
Maximum observed serum concentration (Cmax) of COVI-GUARD
Time frame: Randomization through study completion through Day 60
t½ of COVI-GUARD (PK)
Apparent serum terminal elimination half life (t½) of COVI-GUARD
Time frame: Randomization through study completion through Day 60
Tmax of COVI-GUARD (PK)
Time to Cmax (Tmax) of COVI-GUARD
Time frame: Randomization through study completion through Day 60