NCT04672291 is a Phase 1 clinical trial of Poly-ICLC (Hiltonol®) or Placebo in COVID - 19, sponsored by Oncovir, Inc..

Who is sponsoring NCT04672291?

NCT04672291 is sponsored by Oncovir, Inc..

What drugs are being tested in NCT04672291?

Interventions in NCT04672291: Poly-ICLC (Hiltonol®) or Placebo, Poly-ICLC (Hiltonol®) or Placebo.

What condition does NCT04672291 study?

NCT04672291 studies COVID - 19.

Is NCT04672291 still recruiting?

NCT04672291 is currently completed. Last updated 18 May 2023.

Last reviewed 2023-05-18 · How we verify

NCT04672291

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 18 May 2023

What this trial tests

Phase 1 trial testing Poly-ICLC (Hiltonol®) or Placebo in COVID - 19 in 43 participants. Completed in 1 April 2023.

Timeline

21 July 2021

Primary endpoint
1 April 2023

1 April 2023

Quick facts

Lead sponsor	Oncovir, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	prevention
Enrollment	43
Start date	21 July 2021
Primary completion	1 April 2023
Estimated completion	1 April 2023
Sites	1 location across Canada

Drugs / interventions tested

Poly-ICLC (Hiltonol®) or Placebo — full drug profile →
Poly-ICLC (Hiltonol®) or Placebo — full drug profile →

Conditions studied

COVID - 19 — all drugs for COVID - 19 →

Sponsor

Oncovir, Inc. — full company profile →

Who can join

Adults 18 to 69, any sex, with COVID - 19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Recent Advances in the Development of Toll-like Receptor Agonist-Based Vaccine Adjuvants for Infectious Diseases.
Yang JX, Tseng JC, Yu GY, Luo Y, et al · · 2022 · cited 81× · PMID 35214155 · DOI 10.3390/pharmaceutics14020423
Induction of Innate Immune Response by TLR3 Agonist Protects Mice against SARS-CoV-2 Infection.
Tamir H, Melamed S, Erez N, Politi B, et al · · 2022 · cited 27× · PMID 35215785 · DOI 10.3390/v14020189
Progress towards Adjuvant Development: Focus on Antiviral Therapy.
Brai A, Poggialini F, Pasqualini C, Trivisani CI, et al · · 2023 · cited 13× · PMID 37298177 · DOI 10.3390/ijms24119225
Immunogenicity of SARS-CoV-2 Trimeric Spike Protein Associated to Poly(I:C) Plus Alum.
Dos-Santos JS, Firmino-Cruz L, da Fonseca-Martins AM, Oliveira-Maciel D, et al · · 2022 · cited 7× · PMID 35844561 · DOI 10.3389/fimmu.2022.884760
Therapeutic Targeting of Innate Immune Receptors Against SARS-CoV-2 Infection.
Farooq M, Khan AW, Ahmad B, Kim MS, et al · · 2022 · cited 5× · PMID 35847031 · DOI 10.3389/fphar.2022.915565
Bacteriophage-Derived Double-Stranded RNA Exerts Anti-SARS-CoV-2 Activity In Vitro and in Golden Syrian Hamsters In Vivo.
Vaivode K, Verhovcova I, Skrastina D, Petrovska R, et al · · 2022 · cited 4× · PMID 36145274 · DOI 10.3390/ph15091053
Involvement of nucleic acid-sensing toll-like receptors in human diseases and their controlling mechanisms.
Lin YS, Chang YC, Pu TY, Chuang TH, et al · · 2025 · cited 3× · PMID 40495154 · DOI 10.1186/s12929-025-01151-9
Immunogenicity of SARS-CoV-2 trimetric spike protein associated to Poly(I:C) plus Alum
dos-Santos JS, Firmino-Cruz L, Fonseca-Martins AMd, Oliveira-Maciel D, et al · · 2021 · DOI 10.1101/2021.10.05.461434

Verify or expand the search:

Other recruiting trials for COVID - 19

Currently open trials in the same condition.

NCT07197164 — Safety and Effectiveness of a Remdesivir Treatment to Prevent Severe COVID-19 in Kidney Transplant Patients · Phase 2 · recruiting
NCT07150871 — Impact of Covid-19 on Syphilis · active not recruiting
NCT07204366 — Autoantibodies Against Type I Interferon in Patients Affected With Ph-negative Myeloproliferative Neoplasms (MPN-IFN Stu · active not recruiting

Other Oncovir, Inc. trials

Trials by the same sponsor.

NCT04525859 — Poly-ICLC (Hiltonol®) Vaccine In Malignant Pleural Mesothelioma · Phase 1 · completed
NCT03721679 — Poly-ICLC (Hiltonol) and Anti-PD1 or Anti-PD-L1 · Phase 1, PHASE2 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04672291 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Oncovir, Inc.
Last refreshed: 18 May 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04672291.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing