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Virus Therapy
PRIME-2-CoV_Beta for COVID-19 (ORFEUS Trial)
Phase 1
Waitlist Available
Research Sponsored by Speransa Therapeutics
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 up to 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new COVID-19 vaccine that uses a weakened virus to help the body recognize and fight the coronavirus. It targets healthy adults who have been vaccinated, a small group of unvaccinated adults, and elderly adults who have been vaccinated. The vaccine works by teaching the immune system to recognize and fight the coronavirus.
Eligible Conditions
- COVID-19
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Number of participants with solicited local reactions at the injection site
Number of participants with solicited systemic reactions
Recommended Phase 2 Dose (RP2D) of PRIME-2-CoV_Beta
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: B-Cohorts: Pre-vaccinated elderlyExperimental Treatment1 Intervention
Elderly participants aged 65-85 years who have been previously vaccinated against COVID-19 with at least two doses of a SARS-CoV-2 mRNA vaccine will be assigned to three groups to receive previously identified doses of PRIME-2-CoV_Beta (two doses, 28 days apart).
Group II: A-Cohorts: SARS-CoV-2 Vaccine-naïveExperimental Treatment1 Intervention
Participants aged 18-55 years who are SARS-CoV-2 vaccine-naïve will receive one preferred dose level of PRIME-2-CoV_Beta that has been identified as optimal in pre-vaccinated A-Cohorts (two doses, 28 days apart).
Group III: A-Cohorts: Pre-vaccinatedExperimental Treatment1 Intervention
Participants aged 18-55 years who have been pre-vaccinated against COVID-19 with at least two doses of a SARS-CoV-2 mRNA vaccine will be assigned to five groups that receive increasing doses of PRIME-2-CoV_Beta (two doses, 28 days apart).
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Speransa TherapeuticsLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently taking medications that can help prevent or treat COVID-19.You are eligible for inclusion in the study if you are healthy.You have experienced heart inflammation or severe side effects after receiving an mRNA vaccine that are not commonly expected.You have a history of heart problems like high blood pressure, heart defects, heart inflammation, blocked arteries, or heart attacks.You may need to take medicine that weakens your immune system in the next 6 months.You have a history of or currently have an autoimmune disease that needs treatment.You have received convalescent serum or other therapies for COVID-19 in the past 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: A-Cohorts: Pre-vaccinated
- Group 2: B-Cohorts: Pre-vaccinated elderly
- Group 3: A-Cohorts: SARS-CoV-2 Vaccine-naïve
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.
COVID-19 Patient Testimony for trial: Trial Name: NCT05367843 — Phase 1