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Virus Therapy

Safety Cohort for COVID-19

Phase 1
Waitlist Available
Research Sponsored by Oncovir, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 91 days
Awards & highlights

Study Summary

This trial is testing the safety of a fourth dose of a COVID-19 vaccine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~91 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 91 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and tolerability of nasally administered Poly-ICLC (Hiltonol®) in healthy adults.
Secondary outcome measures
Assess the response of the body to the study drug (pharmacodynamics)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Safety CohortExperimental Treatment1 Intervention
A randomized (4:1) initial safety cohort of 13 patients will receive 2 cycles of drug (N=10) or placebo (N=3)
Group II: Expansion CohortExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Poly-ICLC (Hiltonol®) or Placebo
2021
Completed Phase 1
~50

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Oncovir, Inc.Lead Sponsor
23 Previous Clinical Trials
605 Total Patients Enrolled
University of CalgaryOTHER
792 Previous Clinical Trials
869,111 Total Patients Enrolled
12 Trials studying COVID-19
19,022 Patients Enrolled for COVID-19
Andres M Salazar, MDStudy DirectorSponsor GmbH

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the trial include subjects aged fifty and over?

"As per the trial's entry requirements, patients must be between 18 and 69 years old. For those younger than 18 there are 135 clinical trials available. Alternatively, 896 studies can be accessed by individuals over 65."

Answered by AI

Are there still opportunities to participate in this experiment?

"Clinicaltrials.gov confirms that the trial is currently recruiting participants, with initial posting on July 21st 2021 and most recent update occurring at the end of March 2022."

Answered by AI

Has the Expansion Cohort been granted permission from the FDA?

"The safety rating for Expansion Cohort was assessed at 1 due to the initial clinical findings from Phase 1 trials, which lacked sufficient evidence of both efficacy and safety."

Answered by AI

Might I be considered a candidate for this trial?

"This medical research project is restricted to individuals between 18 and 69 years old with an active Covid-19 infection. A total of 43 participants can join the study."

Answered by AI

What is the current quota for participants in this investigation?

"Affirmative. Clinicaltrials.gov documents that this clinical trial is presently recruiting, with the initial posting on July 21st 2021 and most recent alteration on March 31st 2022. 43 individuals are needed across a single site for enrolment in the study."

Answered by AI
Recent research and studies
NatureJournal
Differential Roles of MDA5 and RIG-I Helicases in the Recognition of RNA Viruses
Kato, Hiroki, Osamu Takeuchi, Shintaro Sato, Mitsutoshi Yoneyama, Masahiro Yamamoto, Kosuke Matsui, Satoshi Uematsu, et al.. 2006. “Differential Roles of MDA5 and RIG-I Helicases in the Recognition of RNA Viruses”. Nature. Springer Science and Business Media LLC. doi:10.1038/nature04734.
Journal of Clinical InvestigationJournal
Intranasal Poly-ic Treatment Exacerbates Tuberculosis in Mice Through the Pulmonary Recruitment of a Pathogen-permissive Monocyte/macrophage Population
Antonelli, Lis R.V., Antonio Gigliotti Rothfuchs, Ricardo Gonçalves, Ester Roffê, Allen W. Cheever, Andre Bafica, Andres M. Salazar, Carl G. Feng, and Alan Sher. 2010. “Intranasal Poly-ic Treatment Exacerbates Tuberculosis in Mice Through the Pulmonary Recruitment of a Pathogen-permissive Monocyte/macrophage Population”. Journal of Clinical Investigation. American Society for Clinical Investigation. doi:10.1172/jci40817.
Cell ReportsJournal
Large-scale Human Dendritic Cell Differentiation Revealing Notch-dependent Lineage Bifurcation and Heterogeneity
Balan, Sreekumar, Catharina Arnold-Schrauf, Abdenour Abbas, Norbert Couespel, Juliette Savoret, Francesco Imperatore, Alexandra-Chloé Villani, Thien-Phong Vu Manh, Nina Bhardwaj, and Marc Dalod. 2018. “Large-scale Human Dendritic Cell Differentiation Revealing Notch-dependent Lineage Bifurcation and Heterogeneity”. Cell Reports. Elsevier BV. doi:10.1016/j.celrep.2018.07.033.
sigmodon HispidusJournal
Activation of Interferon Response Through Toll-like Receptor 3 Impacts Viral Pathogenesis and Pulmonary Toll-like Receptor Expression During Respiratory Syncytial Virus and Influenza Infections in the Cotton Rat <i>sigmodon Hispidus</i> Model
Boukhvalova, Marina S., Talia B. Sotomayor, Ryan C. Point, Lioubov M. Pletneva, Gregory A. Prince, and Jorge C.G. Blanco. 2010. “Activation of Interferon Response Through Toll-like Receptor 3 Impacts Viral Pathogenesis and Pulmonary Toll-like Receptor Expression During Respiratory Syncytial Virus and Influenza Infections in the Cotton Rat sigmodon Hispidus Model”. Journal of Interferon & Cytokine Research. Mary Ann Liebert Inc. doi:10.1089/jir.2009.0025.
~11 spots leftby Apr 2025
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