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Low Dose Radiation Therapy for COVID-19 (RESCUE1-19 Trial)
Phase 3
Waitlist Available
Led By Mohammad K Khan, MD, PhD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Require supplemental oxygen at the time of enrollment, defined by inability to wean from supplemental oxygen within 24 hours prior to enrollment
Be age 50 or over; Not pregnant (will undergo pregnancy testing if below age 55)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to follow-up day 14 after study start; this may be extended to 28 days after preplanned interim analysis.
Awards & highlights
RESCUE1-19 Trial Summary
This trial compares low dose whole lung radiation therapy to best supportive care and physician's choice in treating patients with COVID-19 infection. Low dose whole lung radiation therapy may work better in improving patients' clinical status, the radiographic appearance of their lungs, or their laboratory blood tests.
Who is the study for?
This trial is for adults aged 50 or older with a confirmed COVID-19 diagnosis, showing severe respiratory symptoms but not requiring intubation within 12 hours of joining. They must be hospitalized for the first time due to COVID-19 and able to follow the study procedures. Pregnant individuals or those previously hospitalized for COVID-19 are excluded.Check my eligibility
What is being tested?
The trial compares low dose whole lung radiation therapy (LD-RT) with best supportive care determined by physicians in improving clinical status, lung appearance on X-rays, and blood tests in patients with COVID-19.See study design
What are the potential side effects?
While specific side effects aren't listed here, low dose radiation may cause fatigue, skin redness at treatment site, mild hair loss over treated area, and could potentially lead to longer-term risks like development of other lung conditions.
RESCUE1-19 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need extra oxygen and haven't been able to stop using it for 24 hours before joining.
Select...
I am 50 years or older and not pregnant.
Select...
My chest scans show visible signs of infection or inflammation.
RESCUE1-19 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to follow-up day 14 after study start; this may be extended up to 28 days after preplanned interim analysis.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to follow-up day 14 after study start; this may be extended up to 28 days after preplanned interim analysis.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to clinical recovery
Secondary outcome measures
ALT
Albumin
Aspartate aminotransferase (AST)
+33 moreRESCUE1-19 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (LDRT)Experimental Treatment1 Intervention
Patients receive best supportive care + low dose RT (whole lung)
Group II: Arm I (physician choice)Active Control1 Intervention
Patients get best supportive care + physician choice of treatment
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,636 Previous Clinical Trials
2,560,559 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,139 Total Patients Enrolled
18 Trials studying COVID-19 Infection
77,456 Patients Enrolled for COVID-19 Infection
Mohammad K Khan, MD, PhDPrincipal InvestigatorEmory University Hospital/Winship Cancer Institute
1 Previous Clinical Trials
10 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I need extra oxygen and haven't been able to stop using it for 24 hours before joining.I am willing and able to follow the study's schedule and procedures.You tested positive for COVID-19 within 5 days before or after joining the study.I can join this trial even if I'm taking treatments for COVID.I am being hospitalized for COVID-19 for the first time within 7 days.I was hospitalized for COVID-19 before, but ED visits don't count.I am 50 years or older and not pregnant.I have severe symptoms like difficulty breathing, coughing, and fever that require urgent treatment.I am 49 years old or younger.My chest scans show visible signs of infection or inflammation.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (physician choice)
- Group 2: Arm II (LDRT)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the most recent opinion from the FDA on Low Dose Radiation Therapy?
"Low Dose Radiation Therapy has been deemed safe by our team, as it is a Phase 3 trial. This means that there is evidence of efficacy as well as multiple rounds of data supporting safety."
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