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Monoclonal Antibodies

Cohort 2 for COVID-19

Phase 1
Waitlist Available
Led By David Hoover, MD
Research Sponsored by SAb Biotherapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights

Study 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.

Eligible Conditions
  • COVID-19
  • Coronavirus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Having Transfusion-Related Adverse Events
Secondary outcome measures
Assesment of the PD of SAB-185 administered intravenously
Concentration of subject anti-SAB-185 antibodies elicited by SAB-185
Immune response elicited by SAB-185
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Cohort 3Experimental Treatment1 Intervention
50mg/kg SAB-185 in normal (0.9%) saline; concentration 20mg/mL (2%)
Group II: Cohort 2Experimental Treatment1 Intervention
25mg/kg SAB-185 in normal (0.9%) saline; concentration 20mg/mL (2%)
Group III: Cohort 1Experimental Treatment1 Intervention
10mg/kg SAB-185 in normal (0.9%) saline; concentration 4mg/mL (0.4%)
Group IV: PlaceboPlacebo Group1 Intervention
Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SAB-185
2020
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

Biomedical Advanced Research and Development AuthorityFED
85 Previous Clinical Trials
910,521 Total Patients Enrolled
16 Trials studying COVID-19
465,819 Patients Enrolled for COVID-19
SAb Biotherapeutics, Inc.Lead Sponsor
5 Previous Clinical Trials
4,199 Total Patients Enrolled
2 Trials studying COVID-19
4,072 Patients Enrolled for COVID-19
Joint Program Executive Office (JPEO) Chemical, Biological, Radiological, and Nuclear Defense (CBRND) Enabling Biotechnologies (EB)UNKNOWN
~4 spots leftby May 2025
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