COVID - 19Phase 1NCT04672291
Nasal Poly-ICLC (Hiltonol®) in Healthy COVID-19 Vaccinated Adults
A Phase 1 study of COVID - 19, run by Oncovir, Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID - 19
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteCanada
- Study dates
- 21 Jul 2021to 1 Apr 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 23Show fewer
- 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
- Willing and able to provide blood, nasopharyngeal swab, and nasal mononuclear samples
- Healthy individuals fully vaccinated with a COVID-19 vaccine and who have had their last dose of COVID-19 vaccination at least 30 days prior to study entry. Healthy individuals vaccinated with a COVID-19 booster shot are eligible for enrollment. The vaccination dates of the doses, and specific vaccine received will be recorded.
- Able to provide informed consent
- Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use adequate methods of contraception (described below) during the study treatment and through 90 days after the last dose of study medication. Female participants of childbearing potential are all those except participants who are surgically sterile, who have medically documented ovarian failure, or who are at least 1 year postmenopausal
- Acceptable Hematologic, renal and liver functions as follows:
- 1. Absolute neutrophil count > 1000/mcL 2. Platelets > 50,000/mcL 3. Hemoglobin >9 g/dL 4. Serum Creatinine ≤ 2.5 mg/dl 5. Liver Function:
- Total bilirubin ≤1.5 mg/dl
- AST ≤ 2.0 mg/dl (≤120 IU or 3x ULN)
Who cannot join
- 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
Show all 20Show fewer
- 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)
- Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is acceptable
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating Investigator
- Principle investigator believes that for one or multiple reasons the participant will be unable to comply with all study visits, or if they believe the trial is not clinically in the best interest of the participant
- Documented allergic or hypersensitivity response to any protein therapeutics (e.g., recombinant proteins, vaccines, intravenous immune globulins, monoclonal antibodies, receptor traps)
- Active, untreated tuberculosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
An initial cohort of 13 participants will receive 2 cycles of drug or placebo per the schedule below under carefully monitored conditions, including examinations to observe and document administration site reaction following consecutive administration cycles of the drug. 10 participants will receive drug and 3 will receive placebo. The safety stopping rule is to implement an enrollment pause if 2 dose limiting toxicity (DLT, see section 5.1) out of the first six or 3 DLTs out of the first 10 participants receiving drug are observed in either cycle 1 or cycle 2. The independent DSMB will conduct a review of the safety data to determine the relatedness of the DLTs to the drug exposure and provide a recommendation to continue. Thus, if safety events are determined to be not (or unlikely) related to drug exposure the trial may resume. The independent DSMB will review safety and tolerance data before the study can continue.
If at most 2 DLTs out of the 10 participants receiving drug are observed, then a Phase Ib expansion cohort will open. The expansion cohort will receive 3 cycles of therapy. A total of 30 participants will be accrued and randomized 4:1 to receive drug (N=24) or placebo (N=6). There will be extensive assessment of toxicity and an early stopping rule to implement an enrollment pause and independent DSMB review of safety data to determine relatedness to drug exposure for recommendation of trial continuation, will be employed as above. Safety and tolerability will be the primary endpoint but secondary endpoints include changes in immunological parameters.
- Conditions
- COVID - 19
- Being tested
- Poly-ICLC (Hiltonol®) or Placebo
- Keywords
- SARS CoV-2, COVID, Prevention, Poly-ICLC, Viral Infection
- Medical subject headings
- COVID-19, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poly-ICLC (Hiltonol®) or PlaceboDrug
Also called Safety
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
Also called Expansion
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).
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. Receives: Drug: Poly-ICLC (Hiltonol®) or Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 91 days
Secondary outcomes (1)
Assess the response of the body to the study drug (pharmacodynamics)
Characterize the pharmacodynamics of the local and systemic innate immune response to repeated doses of intranasal Poly-ICLC (Hiltonol®) by investigating the effects on nasal mononuclear cells and systemic inflammatory markers
Measured: 91 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start21 Jul 2021
- Primary completion1 Apr 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (42)Papers the sponsor has linked to this study.
- Other trials for COVID - 19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Intranasal Poly-ICLC (Hiltonol®) or Placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oncovir, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Calgary
- Responsible party
- Sponsor
- Investigators
- Andres M Salazar, MD, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04672291
- Sponsor's protocol ID
- ONV2020-003
- Status last verified
- May 2023
- First submitted
- 5 Oct 2020
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adams JG, Walls RM. Supporting the Health Care Workforce During the COVID-19 Global Epidemic. JAMA. 2020 Apr 21;323(15):1439-1440. doi: 10.1001/jama.2020.3972. No abstract available.
PubMed 32163102Antonelli LR, Gigliotti Rothfuchs A, Goncalves R, Roffe E, Cheever AW, Bafica A, Salazar AM, Feng CG, Sher A. Intranasal Poly-IC treatment exacerbates tuberculosis in mice through the pulmonary recruitment of a pathogen-permissive monocyte/macrophage population. J Clin Invest. 2010 May;120(5):1674-82. doi: 10.1172/JCI40817. Epub 2010 Apr 12.
PubMed 20389020Balan S, Arnold-Schrauf C, Abbas A, Couespel N, Savoret J, Imperatore F, Villani AC, Vu Manh TP, Bhardwaj N, Dalod M. Large-Scale Human Dendritic Cell Differentiation Revealing Notch-Dependent Lineage Bifurcation and Heterogeneity. Cell Rep. 2018 Aug 14;24(7):1902-1915.e6. doi: 10.1016/j.celrep.2018.07.033.
PubMed 30110645Benveniste EN, Qin H. Type I interferons as anti-inflammatory mediators. Sci STKE. 2007 Dec 11;2007(416):pe70. doi: 10.1126/stke.4162007pe70.
PubMed 18073382Boukhvalova MS, Sotomayor TB, Point RC, Pletneva LM, Prince GA, Blanco JC. 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. J Interferon Cytokine Res. 2010 Apr;30(4):229-42. doi: 10.1089/jir.2009.0025.
PubMed 20038196CDC COVID-19 Response Team. Characteristics of Health Care Personnel with COVID-19 - United States, February 12-April 9, 2020. MMWR Morb Mortal Wkly Rep. 2020 Apr 17;69(15):477-481. doi: 10.15585/mmwr.mm6915e6.
PubMed 32298247Caskey M, Lefebvre F, Filali-Mouhim A, Cameron MJ, Goulet JP, Haddad EK, Breton G, Trumpfheller C, Pollak S, Shimeliovich I, Duque-Alarcon A, Pan L, Nelkenbaum A, Salazar AM, Schlesinger SJ, Steinman RM, Sekaly RP. Synthetic double-stranded RNA induces innate immune responses similar to a live viral vaccine in humans. J Exp Med. 2011 Nov 21;208(12):2357-66. doi: 10.1084/jem.20111171. Epub 2011 Nov 7.
PubMed 22065672Christopher ME, Wong JP. Use of TLR3 receptor agaonists against respiratory viral infections. Anti-inflammatory & Anti-Allergy Agents in Medicinal Chemistry. 2011;10:327-38.
Flynn BJ, Kastenmuller K, Wille-Reece U, Tomaras GD, Alam M, Lindsay RW, Salazar AM, Perdiguero B, Gomez CE, Wagner R, Esteban M, Park CG, Trumpfheller C, Keler T, Pantaleo G, Steinman RM, Seder R. Immunization with HIV Gag targeted to dendritic cells followed by recombinant New York vaccinia virus induces robust T-cell immunity in nonhuman primates. Proc Natl Acad Sci U S A. 2011 Apr 26;108(17):7131-6. doi: 10.1073/pnas.1103869108. Epub 2011 Apr 5.
PubMed 21467219Guerrero-Plata A, Baron S, Poast JS, Adegboyega PA, Casola A, Garofalo RP. Activity and regulation of alpha interferon in respiratory syncytial virus and human metapneumovirus experimental infections. J Virol. 2005 Aug;79(16):10190-9. doi: 10.1128/JVI.79.16.10190-10199.2005.
PubMed 16051812Hill DA, Baron S, Perkins JC, Worthington M, Van Kirk JE, Mills J, Kapikian AZ, Chanock RM. Evaluation of an interferon inducer in viral respiratory disease. JAMA. 1972 Feb 28;219(9):1179-84. No abstract available.
PubMed 4334380Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
PubMed 31986264Kato H, Takeuchi O, Sato S, Yoneyama M, Yamamoto M, Matsui K, Uematsu S, Jung A, Kawai T, Ishii KJ, Yamaguchi O, Otsu K, Tsujimura T, Koh CS, Reis e Sousa C, Matsuura Y, Fujita T, Akira S. Differential roles of MDA5 and RIG-I helicases in the recognition of RNA viruses. Nature. 2006 May 4;441(7089):101-5. doi: 10.1038/nature04734. Epub 2006 Apr 9.
PubMed 16625202Kende M, Paragas J, Salazar AM. The efficacy of poly-ICLC against Ebola-Zaire virus (EBOV) infection in mice and cynomolgus monkeys. Antiviral Res. 2019 Mar;163:179-184. doi: 10.1016/j.antiviral.2018.12.020. Epub 2019 Jan 3.
PubMed 30611774Kindler E, Gil-Cruz C, Spanier J, Li Y, Wilhelm J, Rabouw HH, Zust R, Hwang M, V'kovski P, Stalder H, Marti S, Habjan M, Cervantes-Barragan L, Elliot R, Karl N, Gaughan C, van Kuppeveld FJ, Silverman RH, Keller M, Ludewig B, Bergmann CC, Ziebuhr J, Weiss SR, Kalinke U, Thiel V. Early endonuclease-mediated evasion of RNA sensing ensures efficient coronavirus replication. PLoS Pathog. 2017 Feb 3;13(2):e1006195. doi: 10.1371/journal.ppat.1006195. eCollection 2017 Feb.
PubMed 28158275
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04672291
- Acronym / sponsor ID
- ONV2020-003
- Conditions
- COVID - 19
- Keywords
- SARS CoV-2, COVID, Prevention, Poly-ICLC, Viral Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Oncovir, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Calgary
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
An initial cohort of 13 participants will receive 2 cycles of drug or placebo per the schedule below under carefully monitored conditions, including examinations to observe and document administration site reaction following consecutive administration cycles of the drug. 10 participants will receive drug and 3 will receive placebo. The safety stopping rule is to implement an enrollment pause if 2 dose limiting toxicity (DLT, see section 5.1) out of the first six or 3 DLTs out of the first 10 participants receiving drug are observed in either cycle 1 or cycle 2. The independent DSMB will conduct a review of the safety data to determine the relatedness of the DLTs to the drug exposure and provide a recommendation to continue. Thus, if safety events are determined to be not (or unlikely) related to drug exposure the trial may resume. The independent DSMB will review safety and tolerance data before the study can continue.
If at most 2 DLTs out of the 10 participants receiving drug are observed, then a Phase Ib expansion cohort will open. The expansion cohort will receive 3 cycles of therapy. A total of 30 participants will be accrued and randomized 4:1 to receive drug (N=24) or placebo (N=6). There will be extensive assessment of toxicity and an early stopping rule to implement an enrollment pause and independent DSMB review of safety data to determine relatedness to drug exposure for recommendation of trial continuation, will be employed as above. Safety and tolerability will be the primary endpoint but secondary endpoints include changes in immunological parameters.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Intranasal Poly-ICLC (Hiltonol®) or Placebo
| Arm | Type | Receives |
|---|---|---|
| Safety Cohort | Experimental | Drug: Poly-ICLC (Hiltonol®) or PlaceboA randomized (4:1) initial safety cohort of 13 patients will receive 2 cycles of drug (N=10) or placebo (N=3) |
| Expansion Cohort | Experimental | Drug: Poly-ICLC (Hiltonol®) or PlaceboA 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. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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
- Nasopharyngeal swab for COVID-19 at screening with negative diagnosis of SARS-CoV-2
- Willing and able to provide blood, nasopharyngeal swab, and nasal mononuclear samples
- Healthy individuals fully vaccinated with a COVID-19 vaccine and who have had their last dose of COVID-19 vaccination at least 30 days prior to study entry. Healthy individuals vaccinated with a COVID-19 booster shot are eligible for enrollment. The vaccination dates of the doses, and specific vaccine received will be recorded.
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Poly-ICLC (Hiltonol®) or PlaceboAlso: SafetyThe 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 | Safety Cohort |
| Poly-ICLC (Hiltonol®) or PlaceboAlso: ExpansionThe 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). | Drug | Expansion Cohort |
Primary outcome
Safety and tolerability of nasally administered Poly-ICLC (Hiltonol®) in healthy adults.
Time frame: 91 days
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.
1 secondary outcome
Assess the response of the body to the study drug (pharmacodynamics)
Time frame: 91 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Background: PubMed 32163102Adams JG, Walls RM. Supporting the Health Care Workforce During the COVID-19 Global Epidemic. JAMA. 2020 Apr 21;323(15):1439-1440. doi: 10.1001/jama.2020.3972. No abstract available.
- Results publication: PubMed 20389020Antonelli LR, Gigliotti Rothfuchs A, Goncalves R, Roffe E, Cheever AW, Bafica A, Salazar AM, Feng CG, Sher A. Intranasal Poly-IC treatment exacerbates tuberculosis in mice through the pulmonary recruitment of a pathogen-permissive monocyte/macrophage population. J Clin Invest. 2010 May;120(5):1674-82. doi: 10.1172/JCI40817. Epub 2010 Apr 12.
- Results publication: PubMed 30110645Balan S, Arnold-Schrauf C, Abbas A, Couespel N, Savoret J, Imperatore F, Villani AC, Vu Manh TP, Bhardwaj N, Dalod M. Large-Scale Human Dendritic Cell Differentiation Revealing Notch-Dependent Lineage Bifurcation and Heterogeneity. Cell Rep. 2018 Aug 14;24(7):1902-1915.e6. doi: 10.1016/j.celrep.2018.07.033.
- Results publication: PubMed 18073382Benveniste EN, Qin H. Type I interferons as anti-inflammatory mediators. Sci STKE. 2007 Dec 11;2007(416):pe70. doi: 10.1126/stke.4162007pe70.
- Results publication: PubMed 20038196Boukhvalova MS, Sotomayor TB, Point RC, Pletneva LM, Prince GA, Blanco JC. 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. J Interferon Cytokine Res. 2010 Apr;30(4):229-42. doi: 10.1089/jir.2009.0025.
- Results publication: PubMed 32298247CDC COVID-19 Response Team. Characteristics of Health Care Personnel with COVID-19 - United States, February 12-April 9, 2020. MMWR Morb Mortal Wkly Rep. 2020 Apr 17;69(15):477-481. doi: 10.15585/mmwr.mm6915e6.
- Results publication: PubMed 22065672Caskey M, Lefebvre F, Filali-Mouhim A, Cameron MJ, Goulet JP, Haddad EK, Breton G, Trumpfheller C, Pollak S, Shimeliovich I, Duque-Alarcon A, Pan L, Nelkenbaum A, Salazar AM, Schlesinger SJ, Steinman RM, Sekaly RP. Synthetic double-stranded RNA induces innate immune responses similar to a live viral vaccine in humans. J Exp Med. 2011 Nov 21;208(12):2357-66. doi: 10.1084/jem.20111171. Epub 2011 Nov 7.
- Results publicationChristopher ME, Wong JP. Use of TLR3 receptor agaonists against respiratory viral infections. Anti-inflammatory & Anti-Allergy Agents in Medicinal Chemistry. 2011;10:327-38.
- Results publication: PubMed 21467219Flynn BJ, Kastenmuller K, Wille-Reece U, Tomaras GD, Alam M, Lindsay RW, Salazar AM, Perdiguero B, Gomez CE, Wagner R, Esteban M, Park CG, Trumpfheller C, Keler T, Pantaleo G, Steinman RM, Seder R. Immunization with HIV Gag targeted to dendritic cells followed by recombinant New York vaccinia virus induces robust T-cell immunity in nonhuman primates. Proc Natl Acad Sci U S A. 2011 Apr 26;108(17):7131-6. doi: 10.1073/pnas.1103869108. Epub 2011 Apr 5.
- Results publication: PubMed 16051812Guerrero-Plata A, Baron S, Poast JS, Adegboyega PA, Casola A, Garofalo RP. Activity and regulation of alpha interferon in respiratory syncytial virus and human metapneumovirus experimental infections. J Virol. 2005 Aug;79(16):10190-9. doi: 10.1128/JVI.79.16.10190-10199.2005.
- Results publication: PubMed 4334380Hill DA, Baron S, Perkins JC, Worthington M, Van Kirk JE, Mills J, Kapikian AZ, Chanock RM. Evaluation of an interferon inducer in viral respiratory disease. JAMA. 1972 Feb 28;219(9):1179-84. No abstract available.
- Results publication: PubMed 31986264Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
- Individual participant dataSharing planned: No
Related trials for COVID - 19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andres M Salazar, MD study director
Sponsor GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of COVID - 19, run by Oncovir, Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of nasally administered Poly-ICLC (Hiltonol®) in healthy adults. (time frame: 91 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04672291, which also lists 42 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023.