Nasal Poly-ICLC (Hiltonol®) for Prophylaxis of COVID-19 in Healthy Adults
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|ClinicalTrials.gov Identifier: NCT04672291|
Recruitment Status : Not yet recruiting
First Posted : December 17, 2020
Last Update Posted : February 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|COVID - 19||Drug: Poly-ICLC (Hiltonol®)||Phase 1|
An initial cohort of 13 patients will receive 2 cycles of drug or placebo per the schedule below under carefully monitored conditions, including examinations to rule out evidence of chronic mucosal inflammation due to the drug. 10 patients will receive drug and 3 will receive placebo. The safety stopping rule is to stop the trial early if 2 out of the first six, or 3 out of the first 10, or 4 out of the 13 patients receiving drug experience a dose limiting toxicity (DLT, see section 5.1 ) in either cycle 1 or cycle 2.
If at most 3 patients out of the 10 receiving drug experience a DLT, then a Phase Ib expansion cohort will open. 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). There will be extensive assessment of toxicity and an early stopping rule will be employed as above. Safety and tolerability will be the primary endpoint but secondary endpoints include changes in immunological parameters.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||43 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Intranasal Poly-ICLC (Hiltonol®)|
|Masking:||None (Open Label)|
|Masking Description:||This study consists of 2 treatment groups. Study subjects will be assigned by chance to a treatment group. Group 1 receives the study drug; group 2 receives the placebo. Neither the study subject or the study team will know the group assignments. There will be a 4 out 5 chance of receiving the study drug and 1 out 5 chance of receiving the placebo.|
|Official Title:||A Phase I-Ib, Double-blinded, Randomized Repeated Dose Multicenter, Safety and Immunogenicity Study of Nasal Poly-ICLC (Hiltonol®) for Prophylaxis of COVID-19 in Healthy Adults|
|Estimated Study Start Date :||April 1, 2021|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||January 16, 2024|
Experimental: Safety Cohort
A randomized (4:1) initial safety cohort of 13 patients will receive 2 cycles of drug (N=10) or placebo (N=3)
Drug: Poly-ICLC (Hiltonol®)
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).
Other Name: Safety
Experimental: Expansion Cohort
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.
Drug: Poly-ICLC (Hiltonol®)
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).
Other Name: Expansion
- Safety and tolerability, Dose Limiting Toxicity [ 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.
- Assess the response of the body to the study drug (pharmacodynamics) [ Time Frame: 91 days ]Determining the effect on local and systemic inflammatory markers through blood collection and collection of nasal mononuclear cells
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04672291
|Contact: Andres M Salazar, MD||207 505 email@example.com|
|Contact: Richard Leigh, MBChB, PhDfirstname.lastname@example.org|
|Health Research Innovation Centre|
|Calgary, Alberta, Canada, T2N 4Z6|
|Contact: Curtis Dumonceaux, BSc, CCRP 403-220-2123 email@example.com|
|Contact: Linda Knox, RN, CRE 403-220-2123 firstname.lastname@example.org|
|Principal Investigator: Richard Leigh, MBChB, PhD|
|Study Director:||Andres M Salazar, MD||Sponsor GmbH|