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Virus Therapy
HDT-301 for COVID-19
Phase 1
Waitlist Available
Led By Steven G Reed, Ph.D
Research Sponsored by HDT Bio
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 day 1-422
Awards & highlights
Study Summary
This trial is testing a new vaccine to see if it is safe and if it causes an immune response. The primary endpoint is safety, and the secondary endpoint is if the vaccine causes an immune response.
Eligible Conditions
- COVID-19
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1-422
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1-422
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Lab abnormalities
Medically-attended AE, AESI and SAE
Solicited AE
+1 moreSecondary outcome measures
Immunogenicity Endpoints (magnitude of IgG response)
Immunogenicity Endpoints (magnitude of neutralizing antibodies)
Immunogenicity Endpoints (proportion of IgG responders)
+1 moreOther outcome measures
Exploratory Immunology (IgG isotype profile and magnitude)
Exploratory Immunology (T cell phenotype)
Exploratory Immunology (magnitude alternate antibodies)
+3 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Cohort 3 (previously unvaccinated)Experimental Treatment1 Intervention
Cohort 3 will include 21 individuals with no history of vaccination against COVID-19 who will receive a two-dose schedule of HDT-301 56 days apart. Dose will be escalated from low to mid to high according to predefined safety parameters.
Group II: Cohort 2 (previously vaccinated, single dose recipients)Experimental Treatment1 Intervention
Cohort 2 will include individuals with vaccination against COVID-19 who will receive a one-dose schedule of HDT-301. Dose will be escalated from low to mid to high according to predefined safety parameters.
Group III: Cohort 1 (previously vaccinated, two dose recipients)Experimental Treatment1 Intervention
Cohort 1 will include individuals with vaccination against COVID-19 who will receive a two-dose schedule of HDT-301 56 days apart. Dose will be escalated from low to mid to high according to predefined safety parameters.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Rainier Clinical Research CenterUNKNOWN
3 Previous Clinical Trials
1,356 Total Patients Enrolled
HDT BioLead Sponsor
C3 Research AssociatesUNKNOWN
2 Previous Clinical Trials
96 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a medical condition that makes it unsafe for you to receive vaccinations or have blood drawn in your muscles.You have a long-term liver condition, like fatty liver disease.You have a serious medical or mental health condition that has been diagnosed by a doctor or that you have reported yourself.You have previously taken part in other studies that involved a medication with lipid nanoparticles.Your body mass index (BMI) is between 18.0 and 35.0, which means you are within a healthy weight range.You have a confirmed diagnosis of COVID-19 or have received a COVID-19 vaccine.You have had problems with alcohol or drug abuse in the last 6 months.You have had serious allergic reactions to vaccinations in the past.It is unknown whether you have been vaccinated against the SARS-CoV-2 virus.You smoke or vape regularly (more than three days per week).
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1 (previously vaccinated, two dose recipients)
- Group 2: Cohort 3 (previously unvaccinated)
- Group 3: Cohort 2 (previously vaccinated, single dose recipients)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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