Clinical trial NCT04643561: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Covid19
Keywords: hyperimmune colostrum
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: increase levels of IFNγ
timeFrame: 6 days
Secondary outcomes:
measure: registering adverse events
timeFrame: 30 days
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization, Jerusalem, Israel
Study officials:
References: