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Nasal Poly-ICLC (Hiltonol®) for Prophylaxis of COVID-19 in Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04672291
Recruitment Status : Not yet recruiting
First Posted : December 17, 2020
Last Update Posted : February 21, 2021
Sponsor:
Collaborator:
University of Calgary
Information provided by (Responsible Party):
Oncovir, Inc.

Brief Summary:
This is a randomized (4:1) Phase 1 b safety trial in SARS CoV-2 negative subjects at high risk for infection.

Condition or disease Intervention/treatment Phase
COVID - 19 Drug: Poly-ICLC (Hiltonol®) Phase 1

Detailed Description:

An initial cohort of 13 patients will receive 2 cycles of drug or placebo per the schedule below under carefully monitored conditions, including examinations to rule out evidence of chronic mucosal inflammation due to the drug. 10 patients will receive drug and 3 will receive placebo. The safety stopping rule is to stop the trial early if 2 out of the first six, or 3 out of the first 10, or 4 out of the 13 patients receiving drug experience a dose limiting toxicity (DLT, see section 5.1 ) in either cycle 1 or cycle 2.

If at most 3 patients out of the 10 receiving drug experience a DLT, then a Phase Ib expansion cohort will open. The expansion cohort will receive 3 cycles of therapy. A total of 30 patients will be accrued and randomized 4:1 to receive drug (N=24) or placebo (N=6). There will be extensive assessment of toxicity and an early stopping rule will be employed as above. Safety and tolerability will be the primary endpoint but secondary endpoints include changes in immunological parameters.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Intranasal Poly-ICLC (Hiltonol®)
Masking: None (Open Label)
Masking Description: This study consists of 2 treatment groups. Study subjects will be assigned by chance to a treatment group. Group 1 receives the study drug; group 2 receives the placebo. Neither the study subject or the study team will know the group assignments. There will be a 4 out 5 chance of receiving the study drug and 1 out 5 chance of receiving the placebo.
Primary Purpose: Prevention
Official Title: A Phase I-Ib, Double-blinded, Randomized Repeated Dose Multicenter, Safety and Immunogenicity Study of Nasal Poly-ICLC (Hiltonol®) for Prophylaxis of COVID-19 in Healthy Adults
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : January 16, 2024

Arm Intervention/treatment
Experimental: Safety Cohort
A randomized (4:1) initial safety cohort of 13 patients will receive 2 cycles of drug (N=10) or placebo (N=3)
Drug: Poly-ICLC (Hiltonol®)
The safety cohort (Cohort A) consists of 13 patients who will be randomized to receive 2 cycles of the study drug (N10) or 2 placebo cycles (N3).
Other Name: Safety

Experimental: Expansion Cohort
A randomized (4:1) expansion cohort will receive 3 cycles of drug (N=24) or placebo (N=6). A total of 30 patients will be accrued.
Drug: Poly-ICLC (Hiltonol®)
The expansion cohort will receive 3 cycles of therapy. A total of 30 patients will be accrued and randomized 4:1 to receive drug (N=24) or placebo (N=6).
Other Name: Expansion




Primary Outcome Measures :
  1. Safety and tolerability, Dose Limiting Toxicity [ Time Frame: 91 days ]
    Safety will be measured and tabulated by the number (percent) of participants who experience DLTs (grade 3/4 adverse events) from the start of therapy through the end of the follow up period (day 91), according to DAIDS.


Secondary Outcome Measures :
  1. Assess the response of the body to the study drug (pharmacodynamics) [ Time Frame: 91 days ]
    Determining the effect on local and systemic inflammatory markers through blood collection and collection of nasal mononuclear cells



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects must be 18 years of age or older
  2. Asymptomatic
  3. Nasopharyngeal swab for COVID-9 taken within 3 days of first treatment with negative diagnosis of SARS-CoV-2
  4. Negative serology for SARS-CoV-2
  5. Willing and able to provide blood and nasopharyngeal samples
  6. Health care personnel or subjects with high-risk of exposure to SARS-CoV-2 infection
  7. Able to provide informed consent
  8. Female patients of childbearing potential and male patients with partners of childbearing potential must agree to use adequate methods of contraception (described below) during the study treatment and through 90 days after the last dose of study medication. Female patients of childbearing potential are all those except patients who are surgically sterile, who have medically documented ovarian failure, or who are at least 1 year postmenopausal.
  9. Acceptable Hematologic, renal and liver functions as follows:

    • Absolute neutrophil count > 1000/mcL
    • Platelets > 50,000/mcL
    • Hemoglobin >9 g/dL
    • Serum Creatinine ≤ 2.5 mg/dl
    • Liver Function:

Total bilirubin ≤1.5 mg/dl; AST ≤ 2.0 mg/dl (≤120 IU or 3x ULN)

Exclusion Criteria:

  1. Receipt of any blood product in past 120 days
  2. Allergic rhinitis, chronic sinusitis, or other nasal inflammatory disease that requires daily intranasal or oral medication
  3. Chronic medical problems that require daily nasal administration of medication
  4. Prior nasal or sinus surgery including trans nasal approaches to brain
  5. Chronic pulmonary conditions including severe asthma, COPD, or chronic bronchitis
  6. Autoimmune hepatitis, decompensated liver disease, cardiac ischemia, congestive heart failure, cardiac arrhythmia, neutropenia, thrombocytopenia, severe renal insufficiency
  7. Psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance
  8. Symptoms consistent with COVID-19 infection (fevers, acute onset cough, shortness of breath) at time of screening
  9. Nucleic acid testing evidence of COVID-19 infection at time of screening or on Day 0
  10. Inability to complete therapy with the study product within 24 hours after enrollment
  11. Patients must not be pregnant or nursing due to the unknown potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
  12. Has a diagnosis of primary immunodeficiency
  13. Has active autoimmune disease that has required systemic treatment in the past 1 year

    1. (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
    2. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is acceptable
  14. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator
  15. Principle investigator believes that for one or multiple reasons the patient will be unable to comply with all study visits, or if they believe the trial is not clinically in the best interest of the patient
  16. Documented allergic or hypersensitivity response to any protein therapeutics (e.g., recombinant proteins, vaccines, intravenous immune globulins, monoclonal antibodies, receptor traps)
  17. Active, untreated tuberculosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04672291


Contacts
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Contact: Andres M Salazar, MD 207 505 7144 asalazar@oncovir.com
Contact: Richard Leigh, MBChB, PhD 403-220-2123 rleigh@ucalgary.ca

Locations
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Canada, Alberta
Health Research Innovation Centre
Calgary, Alberta, Canada, T2N 4Z6
Contact: Curtis Dumonceaux, BSc, CCRP    403-220-2123    cjdumonc@ucalgary.ca   
Contact: Linda Knox, RN, CRE    403-220-2123    lknox@ucalgary.ca   
Principal Investigator: Richard Leigh, MBChB, PhD         
Sponsors and Collaborators
Oncovir, Inc.
University of Calgary
Investigators
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Study Director: Andres M Salazar, MD Sponsor GmbH
Publications of Results:
Burrer S, Ma D, Hughes M, Kuhar D, Luckhaupt S, McDaniel C, et al. Characteristics of Health Care Personnel with COVID-19 - United States, February 12-April 9, 2020. CDC Morbidity and Mortality Report. 2020;69.
Christopher ME, Wong JP. Use of TLR3 receptor agaonists against respiratory viral infections. Anti-inflammatory & Anti-Allergy Agents in Medicinal Chemistry. 2011;10:327-38.

Other Publications:
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Responsible Party: Oncovir, Inc.
ClinicalTrials.gov Identifier: NCT04672291    
Other Study ID Numbers: ONV2020-003
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Oncovir, Inc.:
SARS CoV-2
COVID
Prevention
Poly-ICLC
Viral Infection
Additional relevant MeSH terms:
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Poly I-C
Carboxymethylcellulose Sodium
Poly ICLC
Interferon Inducers
Immunologic Factors
Physiological Effects of Drugs
Laxatives
Gastrointestinal Agents
Antiviral Agents
Anti-Infective Agents