At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 43 enrolled
Drug / intervention
Poly-ICLC (Hiltonol®) or Placebo +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I-Ib, Double-blinded, Randomized Repeated Dose Single Center, Safety and Immunogenicity Study of Nasal Poly-ICLC (Hiltonol®) in Healthy COVID-19 Vaccinated Adults
In Brief
A Phase 1 clinical trial evaluating Poly-ICLC (Hiltonol®) or Placebo for COVID - 19. Completed, enrolled 43 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID - 19
CountriesCanada
CollaboratorsUniversity of Calgary
Timeline
Phase 1CompletedFinished
202120222023202420252026
First PostedDec 2020
Enrollment StartJul 2021
Primary CompletionApr 2023
TodayJul 2026
First PostedDec 17, 2020
Enrollment StartJul 21, 2021
Primary CompletionApr 1, 2023
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 5.5 years ago
Interventions
Poly-ICLC (Hiltonol®) or Placebodrug
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).
Poly-ICLC (Hiltonol®) or Placebodrug
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).