Nasal Poly-ICLC (Hiltonol®) in Healthy COVID-19 Vaccinated Adults

NCT04672291 | Completed Phase 1 DMC

• 1 other identifier: ONV2020-003
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized (4:1) Phase 1 b safety trial in adults who have completed their full COVID-19 vaccination schedule at least 30 days prior to study entry.

Conditions

COVID - 19

Keywords

SARS CoV-2; COVID; Prevention; Poly-ICLC; Viral Infection

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of nasally administered Poly-ICLC (Hiltonol®) in healthy adults.

  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.

  91 days

Secondary Outcomes (1)

• Assess the response of the body to the study drug (pharmacodynamics)

  91 days

Study Arms (2)

Safety Cohort

EXPERIMENTAL

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®) or Placebo

Expansion Cohort

EXPERIMENTAL

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®) or Placebo

Interventions

Poly-ICLC (Hiltonol®) or Placebo DRUG

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).

Also known as: Safety

Safety Cohort

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Phase I Cohort A: Subjects must be between 18 and 69 years of age. Phase 1b Cohort B: Subjects must be 18 years of age or older. In order to mitigate risk, no participants over age 70 will be recruited in Cohort A.
• Asymptomatic; defined by experiencing none of the symptoms identified in the Symptom Questionnaire
• fever
• cough
• dyspnea
• fatigue
• muscle or joint pain
• sore throat
• stuffy or runny nose
• nausea/vomiting
• headache
• confusion
• diarrhea
• loss of smell or taste
• Nasopharyngeal swab for COVID-19 at screening with negative diagnosis of SARS-CoV-2

You may not qualify if:

• Individuals not yet fully vaccinated with a COVID-19 vaccine.
• Receipt of any blood product in past 120 days
• Allergic rhinitis, chronic sinusitis, or other nasal inflammatory disease that requires daily intranasal or oral medication
• Chronic medical problems that require daily nasal administration of medication
• Prior nasal or sinus surgery including trans nasal approaches to brain
• Chronic pulmonary conditions including severe asthma, COPD, or chronic bronchitis
• Autoimmune hepatitis, decompensated liver disease, cardiac ischemia, congestive heart failure, cardiac arrhythmia, neutropenia, thrombocytopenia, severe renal insufficiency
• Psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect participant safety and/or compliance
• Symptoms consistent with COVID-19 infection (fevers, acute onset cough, shortness of breath) at time of screening
• Nucleic acid testing evidence of COVID-19 infection at time of screening
• Participants must not be pregnant or nursing due to the unknown potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
• Has a diagnosis of primary immunodeficiency
• Has uncontrolled hypertension that in the opinion of the principal investigator poses unacceptable risk.
• Has active autoimmune disease that has required systemic treatment in the past 1 year
• (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs)

Sponsors & Collaborators

• Oncovir, Inc.: lead
• University of Calgary: collaborator

Study Sites (1)

Health Research Innovation Centre

Calgary, Alberta, T2N 4Z6, Canada

Location

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MeSH Terms

Conditions

COVID-19; Virus Diseases

Interventions

poly ICLC; Safety

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Accident Prevention; Accidents; Public Health; Environment and Public Health

Study Officials

• Andres M Salazar, MD

  Sponsor GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Intranasal Poly-ICLC (Hiltonol®) or Placebo

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: December 17, 2020
• Study Start: July 21, 2021
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)