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Experimental COVID-19 Therapies for COVID-19 (NECTAR Trial)
Phase 2 & 3
Waitlist Available
Research Sponsored by Vanderbilt University Medical Center
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 to hospital discharge or day 90 whichever comes first
Awards & highlights
NECTAR Trial Summary
This trial is testing different treatments to see if they can help people with COVID-19 recover faster and prevent them from getting worse.
Who is the study for?
Adults hospitalized with COVID-19 showing symptoms like fever, cough, chest pain, or shortness of breath and needing oxygen support. Not eligible if they've been in certain other drug trials recently, have severe liver issues, are pregnant/breastfeeding, have end-stage kidney disease on dialysis or specific allergies to trial drugs.Check my eligibility
What is being tested?
The study is testing whether Fostamatinib, TXA127, TRV027 or a placebo can help patients recover faster from COVID-19 and prevent serious complications. Patients will be randomly assigned to one of these treatments to compare their effectiveness.See study design
What are the potential side effects?
Possible side effects may include allergic reactions for those sensitive to the medications being tested. Specific side effects for each drug aren't listed but could range from mild (like headaches) to severe (affecting organs).
NECTAR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 to hospital discharge or day 90 whichever comes first
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to hospital discharge or day 90 whichever comes first
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Oxygen
Secondary outcome measures
28-day mortality
60-day mortality
90-day mortality
+10 moreOther outcome measures
Allergic reaction
Changes in NT-proBNP (when possible, at participating sites)
Hypotension
+5 moreNECTAR Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: TXA127 (4/20/2022 Arm Closed to Accrual)Experimental Treatment1 Intervention
An investigational peptide agonist of Mas receptors.
Group II: TRV027 (4/20/2022 Arm Closed to Accrual)Experimental Treatment1 Intervention
An investigational peptide biased agonist of the AT1 receptor.
Group III: FostamatinibExperimental Treatment1 Intervention
An investigational oral spleen tyrosine kinase inhibitor.
Group IV: PlaceboPlacebo Group1 Intervention
NaCl 0.9% infused to match the duration of the agent for TXA127, TRV027, and APN01.
Orange film-coated, plain, bioconvex tablets for fostamatinib.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fostamatinib
2010
Completed Phase 3
~1510
TXA127
2021
Completed Phase 3
~950
TRV027
2020
Completed Phase 3
~910
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
857 Previous Clinical Trials
671,326 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,698 Previous Clinical Trials
7,491,628 Total Patients Enrolled
Sean CollinsLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a body temperature of 100.4 degrees Fahrenheit or higher that has been recorded or confirmed.You have symptoms or signs of recent COVID-19 infection.You have chest pain.You are not willing or able to participate in the group that will receive TXA127/Ang(1-7).You are not able to or do not want to take the medication fostamatinib.You have trouble breathing.You have a cough.You have participated in another study testing fostamatinib in the last 30 days.Your liver enzymes (AST or ALT) are too high, or your bilirubin levels are too high.You are receiving care focused on managing end-of-life symptoms rather than extending life.You had COVID-19 symptoms more than 14 days before joining the study.Your body has too few infection-fighting white blood cells.You have a serious blockage in the blood vessels leading to your kidneys.You have severe kidney disease and need dialysis.You are currently in the hospital because of COVID-19.You have a known blockage in the pathway where blood leaves the heart.You have participated in a different trial testing RAAS modulation in the last 30 days.You have had a bad reaction to medication that affects the RAAS system or have other allergies that the doctor thinks would make it unsafe for you to be in the study.Unstable blood pressure or heart rate.Your blood oxygen level is low and you need extra oxygen to keep it at a healthy level.You have symptoms of acute COVID-19 like cough, high body temperature, difficulty breathing, chest pain, or abnormal chest imaging.Your blood pressure is too high at the time of screening and randomization.You have tested positive for COVID-19 and are showing signs of ongoing infection.You have tested positive for COVID-19 within 3 days before the study starts.You need to have a negative COVID-19 test within 3 days before joining the study. If you have symptoms of COVID-19, the study doctor will decide if you can still join. If you took a test that is as accurate as the standard test, it might also be accepted.You are expected to need a strong CYP3A inhibitor from the start of the study until 21 days after starting the study.
Research Study Groups:
This trial has the following groups:- Group 1: TRV027 (4/20/2022 Arm Closed to Accrual)
- Group 2: Placebo
- Group 3: Fostamatinib
- Group 4: TXA127 (4/20/2022 Arm Closed to Accrual)
Awards:
This trial has 0 awards, including: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.
Coronavirus Patient Testimony for trial: Trial Name: NCT04924660 — Phase 2 & 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many different hospitals are conducting this clinical trial?
"In total, there are 51 locations where this study is running, with the three main sites being Wake Forest University Health Sciences in Winston-Salem, North carolina, University of New mexico Health Sciences Center in Albuquerque, New Mexico, and Temple University Hospital in Philadelphia, Pennsylvania."
Answered by AI
Is the APN01 study an isolated incident?
"The original APN01 clinical trial took place in 2015 at Vanderbilt University. So far, 18270 similar studies have been completed. There are 12 more active ones, with a great concentration taking place in Winston-Salem, North carolina."
Answered by AI
Are there any patients that have yet to be enrolled in this trial?
"According to the latest update on clinicaltrials.gov, this medical trial is still looking for 1600 patients from 51 different sites. The trial was first posted on July 15th, 2021 and was last updated on September 28th, 2022."
Answered by AI
Who else is applying?
What state do they live in?
Arizona
Massachusetts
Georgia
How old are they?
18 - 65
What site did they apply to?
Chandler Regional Medical Center
Newton-Wellesley Hospital
Ponce de Leon Clinical Research Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
1
Why did patients apply to this trial?
In the name of research. I always love to help out with the advance of a new medication.
PatientReceived 2+ prior treatments
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