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

NCT ID: NCT04643561

Last Updated: 2020-11-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2020-12-31

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.

Conditions

Covid19

Keywords

hyperimmune colostrum

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

intervention

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

Group Type: EXPERIMENTAL

Travelan OTC

Intervention Type: OTHER

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

Interventions

Travelan OTC

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Adult healthy volunteers aged 18 years old and above.

2. No history of drug or alcohol abuse.

3. 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.

4. Patients must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.

5. Patients must satisfy a medical examiner about their fitness to participate in the study.

6. Patients must provide written informed consent to participate in the study

Exclusion Criteria

1. 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

2. Patients with evidence of other serious infectious, malignant, autoimmune, kidney, hepatic, or other non-cardiac systemic disease.

3. Chronic drug therapy of any sort

4. Known allergy to milk

5. 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

6. Participation in another clinical trial within 30 days prior to intervention.

7. Patients with an inability to communicate well with the PI and staff (i.e., language problem, poor mental development or impaired cerebral function).

8. 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.

9. Known substance abuse, including inhaled or injected drugs in the year prior to Screening

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Assaf Potruch

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, , Israel

Countries

Israel

Other Identifiers

healthytravelancov19- HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id