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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04643561
• Other study ID #: healthytravelancov19- HMO-CTIL
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: November 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: November 2020
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Intervention

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

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization, Jerusalem, Israel	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	increase levels of IFN?	The primary objective of this study is to show an increase in levels of IFN? against viral antigens after treatment regimen with Trevalan	6 days
Secondary	registering adverse events	registering if any adverse events from the use of Travelan	30 days