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

Hadassah Medical Center

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Covid19

Treatments: Other: Travelan OTC

Study type: Interventional

Funder types: Other

Identifiers

NCT04643561

healthytravelancov19- HMO-CTIL

Details and patient eligibility

About

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.

Enrollment: 5 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

intervention

Experimental group

Description:

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

Treatment:

Other: Travelan OTC