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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
81 Previous Clinical Trials
909,420 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety, Tolerability, and Pharmacokinetics of SAB-185 in Ambulatory Participants With COVID-19
2020. "Safety, Tolerability, and Pharmacokinetics of SAB-185 in Ambulatory Participants With COVID-19". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04469179.
All > Covid
~5 spots leftby Apr 2025
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