A Phase 1B, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of SAB-185 in Ambulatory Subjects With COVID-19

SAb Biotherapeutics, Inc.3 sites in 1 country21 target enrollmentAugust 20, 2020

ConditionsCOVID-19 SARS-CoV2

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: COVID-19
Sponsor: SAb Biotherapeutics, Inc.
Enrollment: 21
Locations: 3
Primary Endpoint: Number of Participants Having Transfusion-Related Adverse Events
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

: 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.

Registry

clinicaltrials.gov

Start Date

August 20, 2020

End Date

November 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

SAb Biotherapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects must meet all of the following criteria for inclusion:
•18-60 years of age
•Positive for presence of SARS-CoV-2 on NP or OP swab by FDA-authorized RT-PCR test within seven days prior to infusion
•At least one current symptom of COVID-19, onset within seven days prior to infusion:
•Fever or chills
•Shortness of breath or difficulty breathing
•Muscle or body aches
•New loss of taste or smell
•Sore throat
•Congestion or runny nose

Exclusion Criteria

•Subjects who meet any of the criteria of severe or higher COVID-19 will be excluded from the study:
•Dyspnea at rest
•Respiratory rate \> 30 breaths per minute
•SpO2 ≤ 93% on room air
•Heart rate ≥ 125 beats per minute
•Respiratory distress or respiratory failure.
•Evidence of critical illness
•Female subjects with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period.
•Hospitalization or need for hospitalization for any cause
•Treatment or participation in another clinical trial of any other investigational agent within 30 days prior to enrollment.

Outcomes

Primary Outcomes

Number of Participants Having Transfusion-Related Adverse Events

Time Frame: 29 Days

transfusion-related adverse events

Number of Participants Having Adverse Events

Time Frame: 29 Days

Incidence and severity of other adverse events and severe adverse events (SAE)

Secondary Outcomes

Incidence of SARS-CoV-2 in oropharyngeal (OP) or nasopharyngeal (NP) swab specimens(29 Days)
Concentration of subject anti-SAB-185 antibodies elicited by SAB-185(90 Days)
Number of Participants Having Adverse Events(90 Days)
Assesment of the PD of SAB-185 administered intravenously(90 Days)
Immune response elicited by SAB-185(90 Days)
Level of SARS-CoV-2 in oropharyngeal (OP) or nasopharyngeal (NP) swab specimens(29 Days)