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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04567810




Registration number
NCT04567810
Ethics application status
Date submitted
18/09/2020
Date registered
29/09/2020
Date last updated
21/12/2020

Titles & IDs
Public title
Safety, Tolerability, and Pharmacokinetics of Anti-Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Chicken Egg Antibody (IgY) (COVID-19)
Scientific 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)
Secondary ID [1] 0 0
CVR001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Covid19 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - anti-SARS-CoV-2 IgY
Treatment: Drugs - Placebo

Experimental: Part A: 2 mg preparation - Participants receive a single 2 mg dose of anti-SARS-CoV-2 IgY.

Experimental: Part A: 4 mg preparation - Participants receive a single 4 mg dose of anti-SARS-CoV-2 IgY.

Experimental: Part A: 8 mg preparation - Participants receive a single 8 mg dose of anti-SARS-CoV-2 IgY.

Placebo Comparator: Part A: placebo preparation - Participants receive placebo matching anti-SARS-CoV-2 IgY.

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.

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.

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.

Placebo Comparator: Part B: 0 mg total daily dose - Participants receive placebo matching anti-SARS-CoV-2 IgY three times daily for 14 days.


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

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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with treatment-related adverse events
Timepoint [1] 0 0
up to 21 days
Secondary outcome [1] 0 0
Number of Participants With Vital Sign Findings Reported as TEAEs
Timepoint [1] 0 0
up to 21 days
Secondary outcome [2] 0 0
Number of Participants With Clinically Significant Findings in Physical Examinations - Clinically significant in the judgement of the investigator.
Timepoint [2] 0 0
up to 21 days
Secondary outcome [3] 0 0
Number of Participants With Clinically Significant Changes From Baseline in ECG Data - Clinically significant in the judgement of the investigator.
Timepoint [3] 0 0
up to 21 days
Secondary outcome [4] 0 0
Number of participants with Clinically Significant Changes from Baseline in Clinical Laboratory Parameters - Clinically significant in the judgement of the investigator.
Timepoint [4] 0 0
up to 21 days
Secondary outcome [5] 0 0
Number of Participants with Presence of Serum anti-SARS-CoV-2 IgY
Timepoint [5] 0 0
up to 21 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
45 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Linear Clinical Research - Harry Perkins Research Institute - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Other
Name
Stanford University
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT04567810
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Daria Mochly-Rosen, PhD
Address 0 0
Stanford University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications