Safety, Tolerability, and Pharmacokinetics of Anti-Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Chicken Egg Antibody (IgY) (COVID-19)

• ClinicalTrials.gov Identifier: NCT04567810
• Recruitment Status: Completed
• First Posted: September 29, 2020
• Last Update Posted: July 6, 2022
• Sponsor: Stanford University
• Information provided by (Responsible Party): Stanford University

Tracking Information

• First Submitted Date: September 18, 2020
• First Posted Date: September 29, 2020
• Last Update Posted Date: July 6, 2022
• Actual Study Start Date: September 18, 2020
• Actual Primary Completion Date: December 14, 2020 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 25, 2020): Number of participants with treatment-related adverse events [ Time Frame: up to 21 days ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 25, 2020)

• Number of Participants With Vital Sign Findings Reported as TEAEs [ Time Frame: up to 21 days ]
• Number of Participants With Clinically Significant Findings in Physical Examinations [ Time Frame: up to 21 days ]
  Clinically significant in the judgement of the investigator.
• Number of Participants With Clinically Significant Changes From Baseline in ECG Data [ Time Frame: up to 21 days ]
  Clinically significant in the judgement of the investigator.
• Number of participants with Clinically Significant Changes from Baseline in Clinical Laboratory Parameters [ Time Frame: up to 21 days ]
  Clinically significant in the judgement of the investigator.
• Number of Participants with Presence of Serum anti-SARS-CoV-2 IgY [ Time Frame: up to 21 days ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety, Tolerability, and Pharmacokinetics of Anti-Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Chicken Egg Antibody (IgY) (COVID-19)
• Official Title: A Phase 1 Study in Healthy Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single -Ascending and Multiple Doses of an Anti-Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Chicken Egg Antibody (IgY)

Brief Summary

The primary objective of Part 1 (Single Ascending Dose) is to assess the safety and tolerability of anti-SARS-CoV-2 IgY when given as single-ascending doses administered intranasally to healthy participants.

The primary objective of Part 2 (Multiple Dose) is to assess the safety and tolerability of anti-SARS-CoV-2 IgY when given as multiple doses administered intranasally to healthy participants. A secondary objective is to assess the pharmacokinetics of anti-SARS-CoV-2 IgY when given as multiple doses administered intranasally to healthy participants.

Safety will be evaluated using adverse event (AE), physical examination (including vital signs), electrocardiogram, and clinical laboratory data. Pharmacokinetics will be evaluated by serum anti-SARS-CoV-2 IgY concentration.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Sequential Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention
• Condition: Covid19

Intervention

• Drug: anti-SARS-CoV-2 IgY
  anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper.
• Drug: Placebo
  Placebo matching anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper.

Study Arms

• Experimental: Part A: 2 mg preparation
  Participants receive a single 2 mg dose of anti-SARS-CoV-2 IgY.
  Intervention: Drug: anti-SARS-CoV-2 IgY
• Experimental: Part A: 4 mg preparation
  Participants receive a single 4 mg dose of anti-SARS-CoV-2 IgY.
  Intervention: Drug: anti-SARS-CoV-2 IgY
• Experimental: Part A: 8 mg preparation
  Participants receive a single 8 mg dose of anti-SARS-CoV-2 IgY.
  Intervention: Drug: anti-SARS-CoV-2 IgY
• Placebo Comparator: Part A: placebo preparation
  Participants receive placebo matching anti-SARS-CoV-2 IgY.
  Intervention: Drug: Placebo
• Experimental: Part B: 6 mg total daily dose
  Participants receive a 2 mg dose of anti-SARS-CoV-2 IgY three times daily for 14 days.
  Intervention: Drug: anti-SARS-CoV-2 IgY
• Experimental: Part B: 12 mg total daily dose
  Participants receive a 4 mg dose of anti-SARS-CoV-2 IgY three times daily for 14 days.
  Intervention: Drug: anti-SARS-CoV-2 IgY
• Experimental: Part B: 24 mg total daily dose
  Participants receive a 8 mg dose of anti-SARS-CoV-2 IgY three times daily for 14 days.
  Intervention: Drug: anti-SARS-CoV-2 IgY
• Placebo Comparator: Part B: 0 mg total daily dose
  Participants receive placebo matching anti-SARS-CoV-2 IgY three times daily for 14 days.
  Intervention: Drug: Placebo

Publications *

• Frumkin LR, Lucas M, Scribner CL, Ortega-Heinly N, Rogers J, Yin G, Hallam TJ, Yam A, Bedard K, Begley R, Cohen CA, Badger CV, Abbasi SA, Dye JM, McMillan B, Wallach M, Bricker TL, Joshi A, Boon ACM, Pokhrel S, Kraemer BR, Lee L, Kargotich S, Agochiya M, John TS, Mochly-Rosen D. Egg-Derived Anti-SARS-CoV-2 Immunoglobulin Y (IgY) With Broad Variant Activity as Intranasal Prophylaxis Against COVID-19. Front Immunol. 2022 Jun 1;13:899617. doi: 10.3389/fimmu.2022.899617. eCollection 2022.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 25, 2020): 48
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 14, 2020
• Actual Primary Completion Date: December 14, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Healthy males or non-pregnant, non-lactating females
• Body weight of at least 50 kg
• Good state of health (mentally and physically)
• Must agree to use of highly effective method of contraception

Exclusion Criteria:

• Received other investigational drug within the last 30 days prior to screening
• History of drug or alcohol abuse in the past 2 years (>21 units of alcohol per week for males and >14 units of alcohol per week for females)
• Current smoker / e-smoker
• Abnormal kidney function
• Abnormal liver function
• Positive for hepatitis B or C infection
• Positive for HIV infection
• Positive for SARS-CoV-2 infection
• History of egg allergy
• Abnormal cardiac function

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia

Administrative Information

• NCT Number: NCT04567810
• Other Study ID Numbers: CVR001
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Stanford University
• Original Responsible Party: Same as current
• Current Study Sponsor: Stanford University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Daria Mochly-Rosen, PhD; Stanford University
• Principal Investigator: Michaela Lucas, MD; Linear Clinical Research

• PRS Account: Stanford University
• Verification Date: June 2022