Clinical trial NCT04469179: Safety, Tolerability, and Pharmacokinetics of SAB-185 in Ambulatory Participants With COVID-19
Official title: A Phase 1B, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of SAB-185 in Ambulatory Subjects With COVID-19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: COVID-19
SARS-CoV2
Lead sponsor: SAb Biotherapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Biomedical Advanced Research and Development Authority
name: Joint Program Executive Office (JPEO) Chemical, Biological, Radiological, and Nuclear Defense (CBRND) Enabling Biotechnologies (EB)
First posted: 2020-07-13
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: Number of Participants Having Adverse Events
timeFrame: 29 Days
measure: Number of Participants Having Transfusion-Related Adverse Events
timeFrame: 29 Days
Secondary outcomes:
measure: Number of Participants Having Adverse Events
timeFrame: 90 Days
measure: Assesment of the PD of SAB-185 administered intravenously
timeFrame: 90 Days
measure: Immune response elicited by SAB-185
timeFrame: 90 Days
measure: Concentration of subject anti-SAB-185 antibodies elicited by SAB-185
timeFrame: 90 Days
measure: Incidence of SARS-CoV-2 in oropharyngeal (OP) or nasopharyngeal (NP) swab specimens
timeFrame: 29 Days
measure: Level of SARS-CoV-2 in oropharyngeal (OP) or nasopharyngeal (NP) swab specimens
timeFrame: 29 Days
Other outcomes:
Locations:
city: Miami Beach
country: United States
facility: Quantum Clinical Trials
state: Florida
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Sioux Falls
country: United States
facility: Sanford Health
state: South Dakota
Study officials:
affiliation: ICON GPHS
name: David Hoover, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.