Safety, Tolerability, and Pharmacokinetics of SAB-185 in Ambulatory Participants With COVID-19
A Phase 1B, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of SAB-185 in Ambulatory Subjects With COVID-19
1 other identifier
interventional
21
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 covid19
Started Aug 2020
Typical duration for phase_1 covid19
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2020
CompletedFirst Posted
Study publicly available on registry
July 13, 2020
CompletedStudy Start
First participant enrolled
August 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2021
CompletedOctober 26, 2021
October 1, 2021
6 months
July 8, 2020
October 25, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Participants Having Adverse Events
Incidence and severity of other adverse events and severe adverse events (SAE)
29 Days
Number of Participants Having Transfusion-Related Adverse Events
transfusion-related adverse events
29 Days
Secondary Outcomes (6)
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
Concentration of subject anti-SAB-185 antibodies elicited by SAB-185
90 Days
Incidence of SARS-CoV-2 in oropharyngeal (OP) or nasopharyngeal (NP) swab specimens
29 Days
- +1 more secondary outcomes
Study Arms (4)
Cohort 1
EXPERIMENTAL10mg/kg SAB-185 in normal (0.9%) saline; concentration 4mg/mL (0.4%)
Cohort 2
EXPERIMENTAL25mg/kg SAB-185 in normal (0.9%) saline; concentration 20mg/mL (2%)
Cohort 3
EXPERIMENTAL50mg/kg SAB-185 in normal (0.9%) saline; concentration 20mg/mL (2%)
Placebo
PLACEBO COMPARATORNormal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
- Cough
- Shortness of breath or difficulty breathing
- Fatigue
- Muscle or body aches
- Headache
- New loss of taste or smell
- Sore throat
- Congestion or runny nose
- Nausea or vomiting
- Diarrhea
- Able to understand the study and comply with all study procedures
- +7 more criteria
You may not qualify if:
- 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.
- Use of other drugs that, in the opinion of the investigator, could complicate analysis of SAB-185.
- Subjects with the following risk factors:
- Compromised immune system including confirmed diagnosis of current cancer under treatment, inherited deficiencies of the immune system, immune suppressing medication, or other conditions causing leukopenia or neutropenia
- Known autoimmune condition requiring therapy more intensive than intermittent non-steroidal anti-inflammatories in the prior 6 months (for example: rheumatoid arthritis, lupus, inflammatory bowel disease)
- Chronic respiratory disease including COPD, emphysema, cystic fibrosis, pulmonary hypertension, or other chronic condition that requires the routine use of supplemental oxygen
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Quantum Clinical Trials
Miami Beach, Florida, 33140, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Sanford Health
Sioux Falls, South Dakota, 57117, United States
Related Publications (1)
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
PMID: 34473343DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Hoover, MD
ICON GPHS
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2020
First Posted
July 13, 2020
Study Start
August 20, 2020
Primary Completion
February 25, 2021
Study Completion
November 1, 2021
Last Updated
October 26, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Starting 6 months after publication and ending 36 months following article publication
- Access Criteria
- Anyone who wishes to access the data.
Individual participant data that underlie the results reported in the published article, after deidentification (test, tables, figures, and appendices)