Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety, Tolerability, and Pharmacokinetics of SAB-185 in Ambulatory Participants With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04469179
Recruitment Status : Recruiting
First Posted : July 13, 2020
Last Update Posted : September 9, 2020
Sponsor:
Collaborators:
Biomedical Advanced Research and Development Authority
Joint Program Executive Office (JPEO) Chemical, Biological, Radiological, and Nuclear Defense (CBRND) Enabling Biotechnologies (EB)
Information provided by (Responsible Party):
SAb Biotherapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
COVID-19 SARS-CoV2 Biological: SAB-185 Other: Normal Saline Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1B, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of SAB-185 in Ambulatory Subjects With COVID-19
Actual Study Start Date : August 20, 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Cohort 1
10mg/kg SAB-185 in normal (0.9%) saline; concentration 4mg/mL (0.4%)
Biological: SAB-185
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.
Other Name: Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (Tc bovine-derived)

Experimental: Cohort 2
25mg/kg SAB-185 in normal (0.9%) saline; concentration 20mg/mL (2%)
Biological: SAB-185
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.
Other Name: Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (Tc bovine-derived)

Experimental: Cohort 3
50mg/kg SAB-185 in normal (0.9%) saline; concentration 20mg/mL (2%)
Biological: SAB-185
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.
Other Name: Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (Tc bovine-derived)

Placebo Comparator: Placebo
Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm.
Other: Normal Saline
Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm.




Primary Outcome Measures :
  1. Number of Participants Having Adverse Events [ Time Frame: 29 Days ]
    Incidence and severity of other adverse events and severe adverse events (SAE)

  2. Number of Participants Having Transfusion-Related Adverse Events [ Time Frame: 29 Days ]
    transfusion-related adverse events


Secondary Outcome Measures :
  1. Number of Participants Having Adverse Events [ Time Frame: 90 Days ]
    Incidence and severity of adverse events and SAEs from Screening through Study Day 90

  2. Assesment of the PD of SAB-185 administered intravenously [ Time Frame: 90 Days ]
    Measurement of SARS CoV-2 neutralizing (PRNT80) antibody titers from screening through Study Day 90

  3. Immune response elicited by SAB-185 [ Time Frame: 90 Days ]
    Measurement of Rheumatoid factor through day 90

  4. Concentration of subject anti-SAB-185 antibodies elicited by SAB-185 [ Time Frame: 90 Days ]
    Measurement of anti-SAB-185 antibodies through screening day 90

  5. Incidence of SARS-CoV-2 in oropharyngeal (OP) or nasopharyngeal (NP) swab specimens [ Time Frame: 29 Days ]
    Incidence of SARS-CoV-2 in swab specimens as measured by quantitative RT-PCR through Study Day 29

  6. Level of SARS-CoV-2 in oropharyngeal (OP) or nasopharyngeal (NP) swab specimens [ Time Frame: 29 Days ]
    Level of SARS-CoV-2 in swab specimens as measured by quantitative RT-PCR through Study Day 29



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects must meet all of the following criteria for inclusion:

  1. 18-60 years of age
  2. Positive for presence of SARS-CoV-2 on NP or OP swab by FDA-authorized RT-PCR test within seven days prior to infusion
  3. 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
  4. Able to understand the study and comply with all study procedures
  5. Agrees not to participate in any other trial of an investigational product during the study period
  6. Willing and able to provide written informed consent prior to the start of any study related activities
  7. If female, meets at least one of the following reproductive risk criteria

    • Post-menopausal for at least 12 months
    • Use of one or more of the following highly effective contraceptive methods for at least 90 days following the last dose of study product: combined estrogen and progestogen containing or progestogen-only hormonal contraception, intrauterine device (IUD), intrauterine hormone-releasing system, surgical bilateral tubal occlusion
    • Vasectomized sole sexual partner who has received medical assessment of the surgical success
  8. Male and female subjects agree to sexual abstinence (refraining from heterosexual intercourse for at least 90 days following the last dose of study product) if not using birth control or condoms for males.

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

    1. Female subjects with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period.
    2. Hospitalization or need for hospitalization for any cause
    3. Treatment or participation in another clinical trial of any other investigational agent within 30 days prior to enrollment.
    4. Use of other drugs that, in the opinion of the investigator, could complicate analysis of SAB-185.
    5. 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
  • Chronic asthma requiring the use of oral steroids or hospitalization in the last six months
  • Renal failure or renal insufficiency requiring dialysis
  • Congestive heart failure or significant atherosclerotic disease (coronary artery disease or peripheral vascular disease) 6. Receipt of pooled immunoglobulin or plasma in past 30 days 7. Any other underlying medical (cardiac, liver, renal, neurological, respiratory) or psychiatric condition that in the view of the investigator would preclude use of SAB-185 8. Known IgA deficiency or previous allergic reaction to intravenous immunoglobin (IVIG)/subcutaneous immunoglobin (SCIG) 9. Positive for hepatitis B virus surface antigen, hepatitis C virus antibody, or HIV antibody by medical history 10. History of allergy, anaphylaxis, or severe reaction to beef products (including milk and gelatin).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04469179


Contacts
Layout table for location contacts
Contact: Moronke Iyoha 1.800.431.9640 ext x269 MIyoha@icongphs.com

Locations
Layout table for location information
United States, Florida
Quantum Clinical Trials Recruiting
Miami Beach, Florida, United States, 33140
Contact: Jack Herman    954-350-0767    jack@qctrials.com   
Principal Investigator: Gene Neytman         
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: LuAnn Larson    402-559-8555    llarson@unmc.edu   
Principal Investigator: Andre Kalil         
United States, South Dakota
Sanford Health Recruiting
Sioux Falls, South Dakota, United States, 57117
Contact: Kathryn Pohlson    605-312-6132    mailto:kathryn.pohlson@sanfordhealth.org   
Principal Investigator: Susan Hoover, MD         
Sponsors and Collaborators
SAb Biotherapeutics, Inc.
Biomedical Advanced Research and Development Authority
Joint Program Executive Office (JPEO) Chemical, Biological, Radiological, and Nuclear Defense (CBRND) Enabling Biotechnologies (EB)
Investigators
Layout table for investigator information
Principal Investigator: David Hoover, MD ICON GPHS
Layout table for additonal information
Responsible Party: SAb Biotherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04469179    
Other Study ID Numbers: SAB-185-102
First Posted: July 13, 2020    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in the published article, after deidentification (test, tables, figures, and appendices)
Supporting Materials: 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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Immunoglobulins
Immunoglobulins, Intravenous
Immunologic Factors
Physiological Effects of Drugs