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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Covid19	Drug: anti-SARS-CoV-2 IgY; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• 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)
• Actual Study Start Date: September 18, 2020
• Actual Primary Completion Date: December 14, 2020
• Actual Study Completion Date: December 14, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Part A: 2 mg preparation; Participants receive a single 2 mg dose of anti-SARS-CoV-2 IgY.	Drug: anti-SARS-CoV-2 IgY; anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper.
Experimental: Part A: 4 mg preparation; Participants receive a single 4 mg dose of anti-SARS-CoV-2 IgY.	Drug: anti-SARS-CoV-2 IgY; anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper.
Experimental: Part A: 8 mg preparation; Participants receive a single 8 mg dose of anti-SARS-CoV-2 IgY.	Drug: anti-SARS-CoV-2 IgY; anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper.
Placebo Comparator: Part A: placebo preparation; Participants receive placebo matching anti-SARS-CoV-2 IgY.	Drug: Placebo; Placebo matching anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper.
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.	Drug: anti-SARS-CoV-2 IgY; anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper.
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.	Drug: anti-SARS-CoV-2 IgY; anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper.
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.	Drug: anti-SARS-CoV-2 IgY; anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper.
Placebo Comparator: Part B: 0 mg total daily dose; Participants receive placebo matching anti-SARS-CoV-2 IgY three times daily for 14 days.	Drug: Placebo; Placebo matching anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper.

Outcome Measures

Primary Outcome Measures :

1. Number of participants with treatment-related adverse events [ Time Frame: up to 21 days ]

Secondary Outcome Measures :

1. Number of Participants With Vital Sign Findings Reported as TEAEs [ Time Frame: up to 21 days ]
2. Number of Participants With Clinically Significant Findings in Physical Examinations [ Time Frame: up to 21 days ]
   Clinically significant in the judgement of the investigator.
3. 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.
4. 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.
5. Number of Participants with Presence of Serum anti-SARS-CoV-2 IgY [ Time Frame: up to 21 days ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Australia, Western Australia

Linear Clinical Research - Harry Perkins Research Institute

Nedlands, Western Australia, Australia, 6009

Sponsors and Collaborators

Stanford University

Investigators

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

More Information

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Stanford University
• ClinicalTrials.gov Identifier: NCT04567810
• Other Study ID Numbers: CVR001
• First Posted: September 29, 2020
• Last Update Posted: July 6, 2022
• Last Verified: June 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

COVID-19; Severe Acute Respiratory Syndrome; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases