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

NCT04672291 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2023-05-18

No results posted yet for this study

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

Interventions

DRUG

Poly-ICLC (Hiltonol®) or Placebo

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).

DRUG

Poly-ICLC (Hiltonol®) or Placebo

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).

Sponsors & Collaborators

  • University of Calgary

    collaborator OTHER

  • Oncovir, Inc.

    lead INDUSTRY

Principal Investigators

  • Andres M Salazar, MD · Sponsor GmbH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-21
Primary Completion
2023-04-01
Completion
2023-04-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04672291 on ClinicalTrials.gov