AzTrials
AzTrials

COVID-19Phase 1NCT04469179

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

A Phase 1 study testing SAB-185 and Normal Saline in people with COVID-19 and SARS-CoV2, run by SAb Biotherapeutics, Inc. at 3 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
COVID-19, SARS-CoV2
What is being tested?
SAB-185 and Normal Saline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
21 participants
Where
3 sitesUnited States
Study dates
20 Aug 2020to Nov 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
  • Cough
Show all 23Show fewer
  • 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
  • Agrees not to participate in any other trial of an investigational product during the study period
  • Willing and able to provide written informed consent prior to the start of any study related activities
  • 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
  • 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.

Who cannot join

  • 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.
Show all 18Show fewer
  • 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
  • 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).

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Quantum Clinical Trials

    Miami Beach, Florida, 33140

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Sanford Health

    Sioux Falls, South Dakota, 57117

Other trials in United States

About this study

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

: 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.

Conditions
COVID-19, SARS-CoV2
Being tested
SAB-185, Normal Saline
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAB-185Biological

    Also called Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (Tc bovine-derived)

    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 SalineOther

    Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm.

Study groups in NCT04469179
Study groupRoleWhat they receive
Cohort 1Experimental10mg/kg SAB-185 in normal (0.9%) saline; concentration 4mg/mL (0.4%)
Receives: Biological: SAB-185
Cohort 2Experimental25mg/kg SAB-185 in normal (0.9%) saline; concentration 20mg/mL (2%)
Receives: Biological: SAB-185
Cohort 3Experimental50mg/kg SAB-185 in normal (0.9%) saline; concentration 20mg/mL (2%)
Receives: Biological: SAB-185
PlaceboPlacebo comparatorNormal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm.
Receives: Other: Normal Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Having Adverse Events

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

    Measured: 29 Days

  2. Number of Participants Having Transfusion-Related Adverse Events

    transfusion-related adverse events

    Measured: 29 Days

Secondary outcomes (6)

  1. Number of Participants Having Adverse Events

    Incidence and severity of adverse events and SAEs from Screening through Study Day 90

    Measured: 90 Days

  2. Assesment of the PD of SAB-185 administered intravenously

    Measurement of SARS CoV-2 neutralizing (PRNT80) antibody titers from screening through Study Day 90

    Measured: 90 Days

  3. Immune response elicited by SAB-185

    Measurement of Rheumatoid factor through day 90

    Measured: 90 Days

  4. Concentration of subject anti-SAB-185 antibodies elicited by SAB-185

    Measurement of anti-SAB-185 antibodies through screening day 90

    Measured: 90 Days

  5. Incidence of SARS-CoV-2 in oropharyngeal (OP) or nasopharyngeal (NP) swab specimens

    Incidence of SARS-CoV-2 in swab specimens as measured by quantitative RT-PCR through Study Day 29

    Measured: 29 Days

  6. Level of SARS-CoV-2 in oropharyngeal (OP) or nasopharyngeal (NP) swab specimens

    Level of SARS-CoV-2 in swab specimens as measured by quantitative RT-PCR through Study Day 29

    Measured: 29 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2020
  2. Study start20 Aug 2020
  3. Primary completion25 Feb 2021
  4. Study completionNov 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04469179
Sponsor's protocol ID
SAB-185-102
Status last verified
Oct 2021
First submitted
8 Jul 2020
Last updated
26 Oct 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in the published article, after deidentification (test, tables, figures, and appendices)

Publications

  • 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.

    PubMed 34473343

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SAB-185 and Normal Saline in people with COVID-19 and SARS-CoV2, run by SAb Biotherapeutics, Inc. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Having Adverse Events (time frame: 29 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04469179, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in