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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)

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ClinicalTrials.gov Identifier: NCT04567810
Recruitment Status : Completed
First Posted : September 29, 2020
Last Update Posted : September 20, 2021
Sponsor:
Information provided by (Responsible Party):
Stanford University

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

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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

Resource links provided by the National Library of Medicine


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.




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 ]


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04567810


Locations
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Australia, Western Australia
Linear Clinical Research - Harry Perkins Research Institute
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators
Stanford University
Investigators
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Study Director: Daria Mochly-Rosen, PhD Stanford University
Principal Investigator: Michaela Lucas, MD Linear Clinical Research
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT04567810    
Other Study ID Numbers: CVR001
First Posted: September 29, 2020    Key Record Dates
Last Update Posted: September 20, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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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