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

NCT04567810 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: CVR001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events

  up to 21 days

Secondary Outcomes (5)

• Number of Participants With Vital Sign Findings Reported as TEAEs

  up to 21 days

• Number of Participants With Clinically Significant Findings in Physical Examinations

  up to 21 days

• Number of Participants With Clinically Significant Changes From Baseline in ECG Data

  up to 21 days

• Number of participants with Clinically Significant Changes from Baseline in Clinical Laboratory Parameters

  up to 21 days

• Number of Participants with Presence of Serum anti-SARS-CoV-2 IgY

  up to 21 days

Study Arms (8)

Part A: 2 mg preparation

EXPERIMENTAL

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

Drug: anti-SARS-CoV-2 IgY

Part A: 4 mg preparation

EXPERIMENTAL

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

Drug: anti-SARS-CoV-2 IgY

Part A: 8 mg preparation

EXPERIMENTAL

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

Drug: anti-SARS-CoV-2 IgY

Part A: placebo preparation

PLACEBO COMPARATOR

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

Drug: Placebo

Part B: 6 mg total daily dose

EXPERIMENTAL

Participants receive a 2 mg dose of anti-SARS-CoV-2 IgY three times daily for 14 days.

Drug: anti-SARS-CoV-2 IgY

Part B: 12 mg total daily dose

EXPERIMENTAL

Participants receive a 4 mg dose of anti-SARS-CoV-2 IgY three times daily for 14 days.

Drug: anti-SARS-CoV-2 IgY

Part B: 24 mg total daily dose

EXPERIMENTAL

Participants receive a 8 mg dose of anti-SARS-CoV-2 IgY three times daily for 14 days.

Drug: anti-SARS-CoV-2 IgY

Part B: 0 mg total daily dose

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

anti-SARS-CoV-2 IgY DRUG

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

Part A: 2 mg preparation; Part A: 4 mg preparation; Part A: 8 mg preparation; Part B: 12 mg total daily dose; Part B: 24 mg total daily dose; Part B: 6 mg total daily dose

Placebo DRUG

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

Part A: placebo preparation; Part B: 0 mg total daily dose

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Linear Clinical Research - Harry Perkins Research Institute

Nedlands, Western Australia, 6009, Australia

Location

Related Publications (2)

• 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.

  PMID: 35720389 RESULT

• 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.

  PMID: 34473343 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Daria Mochly-Rosen, PhD

  Stanford University

  STUDY DIRECTOR

• Michaela Lucas, MD

  Linear Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: September 29, 2020
• Study Start: September 18, 2020
• Primary Completion: December 14, 2020
• Study Completion: December 14, 2020
• Last Updated: July 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)