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Using Travelan to Boost Immune Response in Vitro to COVID-19

Primary Purpose

Covid19

Status

Unknown status

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

Travelan OTC

About this trial

This is an interventional other trial for Covid19 focused on measuring hyperimmune colostrum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Adult healthy volunteers aged 18 years old and above.
No history of drug or alcohol abuse.
Females of childbearing potential must be non-pregnant (as determined by a serum pregnancy test at screening and again, prior to each dosing session) and agree to use adequate contraceptive means throughout the study.
Patients must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.
Patients must satisfy a medical examiner about their fitness to participate in the study.
Patients must provide written informed consent to participate in the study

Exclusion Criteria:

Acute illness resulting in emergency department (ED) evaluation or hospitalization in the last 6 month or any acute illness in the last month before enrollment
Patients with evidence of other serious infectious, malignant, autoimmune, kidney, hepatic, or other non-cardiac systemic disease.
Chronic drug therapy of any sort
Known allergy to milk
Over-the-counter drugs, including herbal medications, and prescription drugs (other than those listed above) are not allowed for 4 weeks prior to and throughout the duration of the study
Participation in another clinical trial within 30 days prior to intervention.
Patients with an inability to communicate well with the PI and staff (i.e., language problem, poor mental development or impaired cerebral function).
Patients who will be unavailable for the duration of the trial, are likely to be noncompliant with the protocol, or who are felt to be unsuitable by the PI for any other reason.
Known substance abuse, including inhaled or injected drugs in the year prior to Screening

Sites / Locations

Hadassah Medical Organization, Jerusalem, Israel

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

intervention

Arm Description

5 patients will recieve 5 days treatment with Travelan, blood samples will be taken prior and after intervention

Outcomes

Primary Outcome Measures

increase levels of IFNγ

The primary objective of this study is to show an increase in levels of IFNγ against viral antigens after treatment regimen with Trevalan

Secondary Outcome Measures

registering adverse events

registering if any adverse events from the use of Travelan

Full Information

NCT ID

NCT04643561

First Posted

November 24, 2020

Last Updated

November 24, 2020

Sponsor

Hadassah Medical Organization

1. Study Identification

Unique Protocol Identification Number

NCT04643561

Brief Title

Using Travelan to Boost Immune Response in Vitro to COVID-19

Official Title

A Feasibility Trial Using Trevalan in Healthy Volunteers for Increasing an in Vitro Immune Response to COVID-19 Proteins

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Unknown status

Study Start Date

November 1, 2020 (Actual)

Primary Completion Date

December 31, 2020 (Anticipated)

Study Completion Date

December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hadassah Medical Organization

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The gut immune system was shown as an effective target for inducing systemic immune signals against viruses. Oral administration of Travelan, an over the counter product which contains hyperimmune bovine colostrum was shown in preclinical studies to augment the anti-viral immune towards several strains of influenza viruses (RNA viruses). This study will evaluate the option that Trevalan may help improve the immune system reaction when introduced to COVID-19 proteins in-vitro. 5 healthy volunteers will receive a treatment regimen of 5 days with Trevalan. Before and after treatment, blood samples will be taken in order to test immune response towards viral proteins of the COVID-19 virus in vitro by measuring the number of T cell clone secreting IFNγ against viral antigens.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

Keywords

hyperimmune colostrum

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

intervention

Arm Type

Experimental

Arm Description

5 patients will recieve 5 days treatment with Travelan, blood samples will be taken prior and after intervention

Intervention Type

Other

Intervention Name(s)

Travelan OTC

Intervention Description

5 days of treatment with Travelan food supplement 3 times a day, blood will be drawn prior and after intervention

Primary Outcome Measure Information:

Title

increase levels of IFNγ

Description

The primary objective of this study is to show an increase in levels of IFNγ against viral antigens after treatment regimen with Trevalan

Time Frame

6 days

Secondary Outcome Measure Information:

Title

registering adverse events

Description

registering if any adverse events from the use of Travelan

Time Frame

30 days

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult healthy volunteers aged 18 years old and above. No history of drug or alcohol abuse. Females of childbearing potential must be non-pregnant (as determined by a serum pregnancy test at screening and again, prior to each dosing session) and agree to use adequate contraceptive means throughout the study. Patients must be able to adhere to the visit schedule and protocol requirements and be available to complete the study. Patients must satisfy a medical examiner about their fitness to participate in the study. Patients must provide written informed consent to participate in the study Exclusion Criteria: Acute illness resulting in emergency department (ED) evaluation or hospitalization in the last 6 month or any acute illness in the last month before enrollment Patients with evidence of other serious infectious, malignant, autoimmune, kidney, hepatic, or other non-cardiac systemic disease. Chronic drug therapy of any sort Known allergy to milk Over-the-counter drugs, including herbal medications, and prescription drugs (other than those listed above) are not allowed for 4 weeks prior to and throughout the duration of the study Participation in another clinical trial within 30 days prior to intervention. Patients with an inability to communicate well with the PI and staff (i.e., language problem, poor mental development or impaired cerebral function). Patients who will be unavailable for the duration of the trial, are likely to be noncompliant with the protocol, or who are felt to be unsuitable by the PI for any other reason. Known substance abuse, including inhaled or injected drugs in the year prior to Screening

Facility Information:

Facility Name

Hadassah Medical Organization, Jerusalem, Israel

City

Jerusalem

Country

Israel

12. IPD Sharing Statement

Learn more about this trial

Using Travelan to Boost Immune Response in Vitro to COVID-19

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