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

NCT ID: NCT04567810

Last Updated: 2022-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-18

Study Completion Date

2020-12-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part A: 2 mg preparation

Participants receive a single 2 mg dose of anti-SARS-CoV-2 IgY.

Group Type EXPERIMENTAL

anti-SARS-CoV-2 IgY

Intervention Type DRUG

anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper.

Part A: 4 mg preparation

Participants receive a single 4 mg dose of anti-SARS-CoV-2 IgY.

Group Type EXPERIMENTAL

anti-SARS-CoV-2 IgY

Intervention Type DRUG

anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper.

Part A: 8 mg preparation

Participants receive a single 8 mg dose of anti-SARS-CoV-2 IgY.

Group Type EXPERIMENTAL

anti-SARS-CoV-2 IgY

Intervention Type DRUG

anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper.

Part A: placebo preparation

Participants receive placebo matching anti-SARS-CoV-2 IgY.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

anti-SARS-CoV-2 IgY

Intervention Type DRUG

anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper.

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.

Group Type EXPERIMENTAL

anti-SARS-CoV-2 IgY

Intervention Type DRUG

anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper.

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.

Group Type EXPERIMENTAL

anti-SARS-CoV-2 IgY

Intervention Type DRUG

anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper.

Part B: 0 mg total daily dose

Participants receive placebo matching anti-SARS-CoV-2 IgY three times daily for 14 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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anti-SARS-CoV-2 IgY

anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daria Mochly-Rosen, PhD

Role: STUDY_DIRECTOR

Stanford University

Michaela Lucas, MD

Role: PRINCIPAL_INVESTIGATOR

Linear Clinical Research

Locations

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Linear Clinical Research - Harry Perkins Research Institute

Nedlands, Western Australia, Australia

Site Status

Countries

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Australia

References

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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.

Reference Type RESULT
PMID: 35720389 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34473343 (View on PubMed)

Other Identifiers

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CVR001

Identifier Type: -

Identifier Source: org_study_id

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