We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety, Tolerability, and Pharmacokinetics of Anti-Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Chicken Egg Antibody (IgY) (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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04567810
Recruitment Status : Completed
First Posted : September 29, 2020
Last Update Posted : July 6, 2022
Sponsor:
Information provided by (Responsible Party):
Stanford University

Tracking Information
First Submitted Date  ICMJE September 18, 2020
First Posted Date  ICMJE September 29, 2020
Last Update Posted Date July 6, 2022
Actual Study Start Date  ICMJE September 18, 2020
Actual Primary Completion Date December 14, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2020)
Number of participants with treatment-related adverse events [ Time Frame: up to 21 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability, and Pharmacokinetics of Anti-Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Chicken Egg Antibody (IgY) (COVID-19)
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Covid19
Intervention  ICMJE
  • 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  ICMJE
  • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 25, 2020)
48
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 14, 2020
Actual Primary Completion Date December 14, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04567810
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Current Responsible Party Stanford University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Stanford University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Daria Mochly-Rosen, PhD Stanford University
Principal Investigator: Michaela Lucas, MD Linear Clinical Research
PRS Account Stanford University
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP