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)

Must not have

Age 49 or younger at time of enrollment

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

No Placebo-Only Group

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I need extra oxygen and haven't been able to stop using it for 24 hours before joining.

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I am 50 years or older and not pregnant.

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My chest scans show visible signs of infection or inflammation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am 49 years old or younger.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to follow-up day 14 after study start; this may be extended up to 28 days after preplanned interim analysis. for reporting.