Covid19Phase 1NCT04567810
Safety, Tolerability, and Pharmacokinetics of Anti-Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Chicken Egg Antibody (IgY) (COVID-19)
A Phase 1 study testing anti-SARS-CoV-2 IgY in people with Covid19, run by Stanford University at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- anti-SARS-CoV-2 IgY
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteAustralia
- Study dates
- 18 Sep 2020to 14 Dec 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Positive for HIV infection
- Positive for SARS-CoV-2 infection
- History of egg allergy
- Abnormal cardiac function
Trial locations and contacts
1 site in 1 country.
Australia1 site
Linear Clinical Research - Harry Perkins Research Institute
Nedlands, Western Australia, 6009
About this study
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)
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
- Being tested
- anti-SARS-CoV-2 IgY, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-SARS-CoV-2 IgYDrug
anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper.
PlaceboDrug
Placebo matching anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper.
| Study group | Role | What they receive |
|---|---|---|
| Part A: 2 mg preparation | Experimental | Participants receive a single 2 mg dose of anti-SARS-CoV-2 IgY. Receives: 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. Receives: 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. Receives: Drug: anti-SARS-CoV-2 IgY |
| Part A: placebo preparation | Placebo comparator | Participants receive placebo matching anti-SARS-CoV-2 IgY. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events
Measured: up to 21 days
Secondary outcomes (5)
Number of Participants With Vital Sign Findings Reported as TEAEs
Measured: up to 21 days
Number of Participants With Clinically Significant Findings in Physical Examinations
Clinically significant in the judgement of the investigator.
Measured: up to 21 days
Number of Participants With Clinically Significant Changes From Baseline in ECG Data
Clinically significant in the judgement of the investigator.
Measured: up to 21 days
Number of participants with Clinically Significant Changes from Baseline in Clinical Laboratory Parameters
Clinically significant in the judgement of the investigator.
Measured: up to 21 days
Number of Participants with Presence of Serum anti-SARS-CoV-2 IgY
Measured: up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start18 Sep 2020
- Primary completion14 Dec 2020
- Study completion14 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daria Mochly-Rosen, PhD, Study director, Stanford UniversityMichaela Lucas, MD, Principal investigator, Linear Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567810
- Sponsor's protocol ID
- CVR001
- Status last verified
- Jun 2022
- First submitted
- 18 Sep 2020
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35720389Kreuzberger 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.
PubMed 34473343
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04567810
- Acronym / sponsor ID
- CVR001
- Conditions
- Covid19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- 14 Dec 2020 (actual)
- Study completion
- 14 Dec 2020 (actual)
- First posted
- 29 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part A: 2 mg preparation | Experimental | Drug: anti-SARS-CoV-2 IgYParticipants receive a single 2 mg dose of anti-SARS-CoV-2 IgY. |
| Part A: 4 mg preparation | Experimental | Drug: anti-SARS-CoV-2 IgYParticipants receive a single 4 mg dose of anti-SARS-CoV-2 IgY. |
| Part A: 8 mg preparation | Experimental | Drug: anti-SARS-CoV-2 IgYParticipants receive a single 8 mg dose of anti-SARS-CoV-2 IgY. |
| Part A: placebo preparation | Placebo comparator | Drug: PlaceboParticipants receive placebo matching anti-SARS-CoV-2 IgY. |
| Part B: 6 mg total daily dose | Experimental | Drug: anti-SARS-CoV-2 IgYParticipants receive a 2 mg dose of anti-SARS-CoV-2 IgY three times daily for 14 days. |
| Part B: 12 mg total daily dose | Experimental | Drug: anti-SARS-CoV-2 IgYParticipants receive a 4 mg dose of anti-SARS-CoV-2 IgY three times daily for 14 days. |
| Part B: 24 mg total daily dose | Experimental | Drug: anti-SARS-CoV-2 IgYParticipants receive a 8 mg dose of anti-SARS-CoV-2 IgY three times daily for 14 days. |
| Part B: 0 mg total daily dose | Placebo comparator | Drug: PlaceboParticipants receive placebo matching anti-SARS-CoV-2 IgY three times daily for 14 days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anti-SARS-CoV-2 IgYanti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper. | Drug | 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 |
| PlaceboPlacebo matching anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper. | Drug | Part A: placebo preparation, Part B: 0 mg total daily dose |
Primary outcome
Number of participants with treatment-related adverse events
Time frame: up to 21 days
5 secondary outcomes
Number of Participants With Vital Sign Findings Reported as TEAEs
Time frame: up to 21 days
Number of Participants With Clinically Significant Findings in Physical Examinations
Time frame: up to 21 days
Number of Participants With Clinically Significant Changes From Baseline in ECG Data
Time frame: up to 21 days
Number of participants with Clinically Significant Changes from Baseline in Clinical Laboratory Parameters
Time frame: up to 21 days
Number of Participants with Presence of Serum anti-SARS-CoV-2 IgY
Time frame: up to 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Results publication: PubMed 35720389Frumkin 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.
- Derived from this study: PubMed 34473343Kreuzberger 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.
- Individual participant dataSharing planned: No
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daria Mochly-Rosen, PhD study director
Stanford University
Michaela Lucas, MD principal investigator
Linear Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing anti-SARS-CoV-2 IgY in people with Covid19, run by Stanford University at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events (time frame: up to 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04567810, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.