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

Covid19 Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04567810
• Other study ID #: CVR001
• Status: Completed
• Phase: Phase 1
• Start date: September 18, 2020
• Est. completion date: December 14, 2020

Study information

• Verified date: June 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 14, 2020
• Est. primary completion date: December 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Severe Acute Respiratory Syndrome

Intervention

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

Locations

Country	Name	City	State
Australia	Linear Clinical Research - Harry Perkins Research Institute	Nedlands	Western Australia

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

Australia, 

References & Publications (1)

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, — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-related adverse events		up to 21 days
Secondary	Number of Participants With Vital Sign Findings Reported as TEAEs		up to 21 days
Secondary	Number of Participants With Clinically Significant Findings in Physical Examinations	Clinically significant in the judgement of the investigator.	up to 21 days
Secondary	Number of Participants With Clinically Significant Changes From Baseline in ECG Data	Clinically significant in the judgement of the investigator.	up to 21 days
Secondary	Number of participants with Clinically Significant Changes from Baseline in Clinical Laboratory Parameters	Clinically significant in the judgement of the investigator.	up to 21 days
Secondary	Number of Participants with Presence of Serum anti-SARS-CoV-2 IgY		up to 21 days