: Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SAB Biotherapeutics has developed SAB-185, an Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (transchromosomic \[Tc\] bovine-derived), as a potential therapeutic to treat COVID-19. This study will evaluate the safety, immunogenicity, and pharmacokinetics of SAB-185 in ambulatory participants with COVID-19.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
21
SAB-185 is a purified human immunoglobulin G (hIgG) designed to specifically bind to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) viruses. SAB-185 is purified from the plasma of immunized Tc bovines that were immunized initially (vaccinations 1 and 2) with a plasmid DNA (pDNA) vaccine that expresses wild-type SARS-CoV-2 spike protein, followed by additional immunizations (vaccinations 3 and beyond) with a recombinant spike protein from SARS-CoV-2 produced in insect cells. The purified hIgG is a sterile liquid formulated in 10 mM glutamic acid monosodium salt, 262 mM D-sorbitol, 0.05 mg/mL Tween 80, pH 5.5. The drug product will be administered intravenously and will be diluted in saline per the clinical protocol.
Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm.
Quantum Clinical Trials
Miami Beach, Florida, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Sanford Health
Sioux Falls, South Dakota, United States
Number of Participants Having Adverse Events
Incidence and severity of other adverse events and severe adverse events (SAE)
Time frame: 29 Days
Number of Participants Having Transfusion-Related Adverse Events
transfusion-related adverse events
Time frame: 29 Days
Number of Participants Having Adverse Events
Incidence and severity of adverse events and SAEs from Screening through Study Day 90
Time frame: 90 Days
Assesment of the PD of SAB-185 administered intravenously
Measurement of SARS CoV-2 neutralizing (PRNT80) antibody titers from screening through Study Day 90
Time frame: 90 Days
Immune response elicited by SAB-185
Measurement of Rheumatoid factor through day 90
Time frame: 90 Days
Concentration of subject anti-SAB-185 antibodies elicited by SAB-185
Measurement of anti-SAB-185 antibodies through screening day 90
Time frame: 90 Days
Incidence of SARS-CoV-2 in oropharyngeal (OP) or nasopharyngeal (NP) swab specimens
Incidence of SARS-CoV-2 in swab specimens as measured by quantitative RT-PCR through Study Day 29
Time frame: 29 Days
Level of SARS-CoV-2 in oropharyngeal (OP) or nasopharyngeal (NP) swab specimens
Level of SARS-CoV-2 in swab specimens as measured by quantitative RT-PCR through Study Day 29
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Time frame: 29 Days