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HDT-301 for COVID-19
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.
- COVID-19
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
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- 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).
- Group 1: Cohort 1 (previously vaccinated, two dose recipients)
- Group 2: Cohort 3 (previously unvaccinated)
- Group 3: Cohort 2 (previously vaccinated, single dose recipients)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Are applications open for the current iteration of this investigation?
"Affirmative. Clinicaltrials.gov reveals that this research endeavour, which was originally published on January 24th 2022, is actively searching for participants. Approximately 63 patients must be enrolled from a single location."
Are individuals younger than 50 years old qualified for participation in this medical experiment?
"As outlined in the study's requirements, individuals from 18 to 65 years old are eligible for enrollment."
What is the total enrollment of this clinical experiment?
"Correct. Per the clinicaltrials.gov website, this research is actively recruiting and was originally posted on January 24th 2022 with a most recent update having occured the following day. There are 63 participants needed at one medical centre for this trial to be completed successfully."
Who is eligible to join in this medical research endeavor?
"Requirements to be accepted into this clinical trial include a positive coronavirus disease 2019 (covid‑19) diagnosis and an age between 18-65 years old. The recruitment goal is 63 participants in total."
What hazards are associated with HDT-301 consumption?
"HDT-301 has not yet been thoroughly evaluated, so it was given a score of 1 on the safety scale. This is due to this being an early phase trial with limited efficacy and safety data available."
What are the fundamental aims of this experiment?
"This medical trial, lasting approximately 85 days, will evaluate the primary outcome of lab abnormalities. Additionally, immunogenicity endpoints such as geometric mean titer (GMT), proportion of participants with a 4-fold increase in SARS-CoV-2 B.1.351 Spike antibody titer from baseline to 28 days after vaccination and proportion responding with neutralizing antibodies will also be assessed for efficacy."
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