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Virus Therapy

Ad26.COV2.S for Participants with or without co-morbidities associated with COVID-19. (ENSEMBLE Trial)

Q: In how many different medical facilities is this investigation being conducted currently?

<p>Patients are currently being accepted at <a href="https://www.withpower.com/clinical-trials/oregon">Oregon</a> Health &#x26; Science University, Tryon Medical Group, The Hope Clinic, and 100 other locations for this study.</p>

Phase 3

Waitlist Available

Research Sponsored by Janssen Vaccines & Prevention B.V.

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 from booster vaccination (year 1) up to end of the study (up to 2 years 3 months)

Awards & highlights

ENSEMBLE Trial Summary

This trial will study if a potential COVID-19 vaccine is effective in preventing moderate to severe/critical cases of the disease.

Eligible Conditions

Participants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19

ENSEMBLE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from booster vaccination (year 1) up to end of the study (up to 2 years 3 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from booster vaccination (year 1) up to end of the study (up to 2 years 3 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from booster vaccination (year 1) up to end of the study (up to 2 years 3 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With Adverse Events of Special Interest (AESI) From Booster Vaccination Until End of the Study (Open-label Booster Vaccination Phase)

Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 With Seronegative Status (Main Study)

Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Main Study)

+6 more

Secondary outcome measures

Binding Antibodies to SARS-CoV-2 S Protein Assessed by ELISA (Main Study)

Number of Participant With BOD Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 (Main Study)

Number of Participants With Adverse Events of Special Interest (AESI) (Main Study)

+16 more

Side effects data

From 2023 Phase 3 trial • 44325 Patients • NCT04505722

Headache

Chills

Fatigue

100%

80%

60%

40%

20%

Study treatment Arm

Ad26.COV2.S

Placebo

ENSEMBLE Trial Design

2Treatment groups

Experimental Treatment

Group I: PlaceboExperimental Treatment2 Interventions

Participants will receive IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo will be offered to receive a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccination (as primary regimen or additional dose) will be offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.

Group II: Ad26.COV2.SExperimental Treatment1 Intervention

Participants will receive intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any coronavirus disease-2019 (COVID-19) vaccination (as primary regimen or additional dose) will be offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ad26.COV2.S

2021

Completed Phase 3

~83790

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Janssen Vaccines & Prevention B.V.Lead Sponsor

55 Previous Clinical Trials

1,090,023 Total Patients Enrolled

Janssen Vaccines & Prevention B.V. Clinical TrialStudy DirectorJanssen Vaccines & Prevention B.V.

47 Previous Clinical Trials

91,231 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many different medical facilities is this investigation being conducted currently?

"Patients are currently being accepted at Oregon Health & Science University, Tryon Medical Group, The Hope Clinic, and 100 other locations for this study."

Answered by AI

Have patients undergone this treatment before as part of a clinical trial?

"9 clinical trials for Ad26.COV2.S are currently underway in 131 cities and 19 countries. The first study was completed in 2020 by Janssen Vaccines & Prevention B.V.. 1085 people participated in the initial Phase 1 & 2 study. Since then, 18269 similar studies have been completed."

Answered by AI

Are we still able to sign up to be a part of this experiment?

"Unfortunately, this particular study is not presently looking for new patients. Although, it's worth noting that the trial was originally posted on September 7th, 2020 and edited as recently as October 25th, 2022. There are 1209 other trials currently underway that might be of interest."

Answered by AI

What is the patient mortality rate for Ad26.COV2.S?

"Ad26.COV2.S has been assessed to be a 3 in terms of safety by our team because it is in Phase 3. This means that not only is there some data affirming its efficacy, but also that there have been multiple rounds of data supporting its safety."

Answered by AI

Are there other ongoing or completed research trials that have studied Ad26.COV2.S?

"Ad26.COV2.S was first trialled in 2020 at SGS Life Science Services. To date, there have been 18269 completed trials. Out of these, 9 are active and underway, a few of which are based in Portland, Oregon."

Answered by AI