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PneumoniaPhase 3RESCUE1-19NCT04433949

Best Supportive Care With or Without Low Dose Whole Lung Radiation Therapy for the Treatment of COVID-19

A Phase 3 study testing Best Practice and Low Dose Radiation Therapy in people with Pneumonia and Severe Acute Respiratory Syndrome, run by Emory University at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This phase III trial compares low dose whole lung radiation therapy to best supportive care plus physicians choice in treating patients with COVID-19 infection. Low dose whole lung radiation therapy may work better than the current best supportive care and physician's choice in improving patients' clinical status, the… Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Best Practice and Low Dose Radiation Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteUnited States
Study dates
23 Jun 2020to 30 May 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Be age 50 or over; Not pregnant (will undergo pregnancy testing if below age 55);
  • Have had a positive PCR-based test confirming the diagnosis of COVID-19 within 5 days (+/-2 day)of study enrollment*
  • Have had clinical signs of severe acute respiratory syndrome or pneumonia (ie. dyspnea, cough,fever) that primary team feels like patient needs rescuing with LD-RT.**
  • Have visible bilateral consolidations/ground glass opacities on chest imaging
  • Require supplemental oxygen at the time of enrollment, defined by inability to wean from supplemental oxygen within 24 hours prior to enrollment.
  • Not require intubation within 12 hours of randomization (ie, not screen fail). Intubation after enrollment but within 12 hours of randomization will be defined as a screen failure for both the LD-RT and control cohorts.
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  • Be enrolled within 5 days (+/- 2) of first hospitalization for COVID-19. Prior hospitalization for COVID-19 will be an exclusion criteria (prior ED visits are permissible).
  • Willingness and ability of the subject to comply with scheduled visits, protocol-specified laboratory tests, other study procedures, and study restrictions
  • Evidence of a signed informed consent/assent indicating that the subject is aware of the infectious nature of the disease and has been informed of the procedures to be followed, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation

Who cannot join

  • Pregnant and/or planned to be pregnant within in next 6 months
  • Age 49 or younger at time of enrollment
  • Prior inpatient hospitalization for COVID-19 (prior emergency department [ED] visits are not an exclusion criteria)
  • Prior enrollment on a separate COVID-19-related therapeutric trial (subsequent co-enrollment is permitted for patinets randomized to the control arm).
  • Notably, concurrent use of COVID-directed therapies is no longer an exclusion criteria for this trial. This includes azithromycin, dexamethasone, remdesevir, convalescent plasma, or any other COVIDdirected drug therapy.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

Other trials in United States

About this study

Official title: Radiation Eliminates Storming Cytokines and Unchecked Edema as a 1-Day Treatment for COVID-19 (RESCUE 1-19): A Randomized Phase III Trial of Best Supportive Care Plus Provider's Choice of Pharmaceutical Treatment With or Without Whole Lung Low-Dose Radiation Therapy (LD-RT) in Hospitalized Patients With COVID-19

This phase III trial compares low dose whole lung radiation therapy to best supportive care plus physicians choice in treating patients with COVID-19 infection. Low dose whole lung radiation therapy may work better than the current best supportive care and physician's choice in improving patients' clinical status, the radiographic appearance of their lungs, or their laboratory blood tests.

Read the detailed description

PRIMARY OBJECTIVE:

  1. Intubation-free survival (IFS) and (2) time to clinical recovery (TTCR) based on weaning off supplementary oxygenation or hospital discharge in COVID 19 patients.

SECONDARY OBJECTIVES:

  1. To investigate (1) other clinical, (2) radiographic, (3) serologic markers, and (4) immune marker response to best supportive care plus provider's choice of pharmaceutical treatment either with or without whole-lung LD-RT

II. Secondary clinical improvements will look at time to hospital discharge, prevention of ICU admissions, and overall survival.

OUTLINE: Patients are blindly randomized to 1 of 2 arms.

ARM I: Patients receive best supportive care plus physician choice of treatment

ARM II: Patients receive best supportive care plus LDRT (experimental arm).

After completion of study, patients are followed up for 14 days.

Being tested
Best Practice, Low Dose Radiation Therapy
Keywords
Radiotherapy, COVID-19, low dose radiotherapy, anti-inflammatory, cytokine storm
Medical subject headings
Pneumonia, Severe Acute Respiratory Syndrome, COVID-19, Cytokine Release Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Best PracticeOther

    Also called standard of care, standard therapy

    Receive standard of care

  • Low Dose Radiation TherapyRadiation

    Also called Low Dose Radiation

    Undergo LDRT

Study groups in NCT04433949
Study groupRoleWhat they receive
Arm I (physician choice)Active comparatorPatients get best supportive care + physician choice of treatment
Receives: Other: Best Practice
Arm II (LDRT)ExperimentalPatients receive best supportive care + low dose RT (whole lung)
Receives: Radiation: Low Dose Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to clinical recovery

    Will be measured by improvements on oxygenation need prior to intervention compared with after intervention and/or hospital discharge.

    Measured: Up to follow-up day 14 after study start

Secondary outcomes (36)

  1. Freedom from ICU admission

    The rates from both cohort will be reported.

    Measured: Up to follow-up day 14 after study start; This may be extended up to 28 days after preplanned interim analysis.

  2. Temperature

    Temperature in degrees (F)

    Measured: Up to follow-up day 14 after study start

  3. Heart rate

    Heart rate in beats per minutes

    Measured: Up to follow-up day 14 after study start

  4. Systolic Blood pressure

    Systolic blood pressure in mm Hg

    Measured: Up to follow-up day 14 after study start

  5. Oxygen saturation

    Oxygen saturation in percentage

    Measured: Up to follow-up day 14 after study start

  6. Supplemental oxygenation need

    Oxygen saturation in percentage

    Measured: Up to follow-up day 14 after study start

  7. Respiratory rate

    Respiratory rate in breaths per minute.

    Measured: Up to follow-up day 14 after study start

  8. Glasgow Comma Scale from minimum of 3 to maximum of 15.

    Pre and post intervention; Minimum of 3 (poor) to best (15)

    Measured: Up to follow-up day 14 after study start

  9. Performance status

    Easter Cooperative Oncology Group (ECOG) Performance Status Scale from 0-5; 0 being best; 5 being dead;

    Measured: Up to follow-up day 14 after study start

  10. Survival

    Survival in percentage

    Measured: Up to follow-up day 14 after study start; This may be extended to 28 days after preplanned interim analysis.

  11. Serial chest x-rays severe acute respiratory syndrome (SARS) scoring

    Serial chest x-rays categorized using published scale into ordinal ranks 1-5 for SARS.

    Measured: Up to follow-up day 14 after study start;

  12. Changes on computed tomography (CT) scans pre and post RT

    CT scans with volume of consolidation measured in cubic centimeters.

    Measured: Baseline up to follow-up day 14 after study start

  13. CRP

    C-Reactive Protein in mg/L

    Measured: Up to follow-up day 14 after study start

  14. Serum chemistry + complete blood cell (CBC) with differential

    Will be summarized descriptively.

    Measured: Up to follow-up day 14 after study start

  15. Blood gases pH(when available)

    pH (no unit)

    Measured: Up to follow-up day 14 after study start

  16. Albumin

    Albumin in gm/dL

    Measured: Up to follow-up day 14 after study start

  17. Procalcitonin

    Procalcitonin in ng/mL

    Measured: Up to follow-up day 14 after study start

  18. Aspartate aminotransferase (AST)

    Asparatate Aminotransferase in units/L

    Measured: Up to follow-up day 14 after study start

  19. Creatine kinase

    Creatinine in mg/dL

    Measured: Up to follow-up day 14 after study start

  20. Prothrombin time (PT)/partial thromboplastin time (PTT)

    Coagulation pathway time in seconds

    Measured: Up to follow-up day 14 after study start

  21. Troponin

    Troponin-I in ng/mL

    Measured: Up to follow-up day 14 after study start

  22. Lactate

    Lactic Acid in mmol/L

    Measured: Up to follow-up day 14 after study start

  23. NT-pBNP (cardiac injury)

    B-Natriuretic Peptid in pg/mL

    Measured: Up to follow-up day 14 after study start

  24. Gamma-glutamyl transferase (GGT)

    Gamma-glutamyl transferase in units/L

    Measured: Up to follow-up day 14 after study start

  25. Triglycerides

    Trygliciericdes in mg/dL

    Measured: Up to follow-up day 14 after study start

  26. Fibrinogen

    Fibrinogen in mg/dL

    Measured: Up to follow-up day 14 after study start

  27. Changes in CD8 T cells

    Will be summarized descriptively.

    Measured: Up to follow-up day 14 after study start

  28. Changes in CD4 T cells

    Will be summarized descriptively.

    Measured: Up to follow-up day 14 after study start

  29. Changes in serum antibodies against COVID-19 epitope

    Will be summarized descriptively.

    Measured: Up to follow-up day 14 after study start

  30. LDH

    Lactate Dehydrogenase in units/L

    Measured: Up to follow-up day 14 after study start

  31. D-Dimer

    D-Dimer in ng/mL

    Measured: Up to follow-up day 14 after study start

  32. IL-6

    Interleukin-6 in pg/mL

    Measured: Up to follow-up day 14 after study start

  33. Myoglobin

    Myoglobin in ng/mL

    Measured: Up to follow-up day 14 after study start

  34. Potassium

    Potassium in mmol/L

    Measured: Up to follow-up day 14 after study start

  35. Ferritin

    Ferritin in ng/mL

    Measured: Up to follow-up day 14 after study start

  36. ALT

    Alanine Aminotransferase in units/L

    Measured: Up to follow-up day 14 after study start

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2020
  2. Study start23 Jun 2020
  3. Primary completion19 Oct 2022
  4. Study completion30 May 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04433949
Sponsor's protocol ID
STUDY00000781
Other IDs
NCI-2020-04061, RAD5049-20, P30CA138292
Acronym
RESCUE1-19
Status last verified
Aug 2023
First submitted
12 Jun 2020
Last updated
14 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: Results of the trial and not individual patient data will be shared. The study protocol, consent, and investigator's brochure will be available. The statistical plan is incorporated into the protocol, along with inclusion and exclusion criteria.

Publications

  • Lara PC, Burgos J, Macias D. Low dose lung radiotherapy for COVID-19 pneumonia. The rationale for a cost-effective anti-inflammatory treatment. Clin Transl Radiat Oncol. 2020 Apr 25;23:27-29. doi: 10.1016/j.ctro.2020.04.006. eCollection 2020 Jul.

    PubMed 32373721

  • Dhawan G, Kapoor R, Dhawan R, Singh R, Monga B, Giordano J, Calabrese EJ. Low dose radiation therapy as a potential life saving treatment for COVID-19-induced acute respiratory distress syndrome (ARDS). Radiother Oncol. 2020 Jun;147:212-216. doi: 10.1016/j.radonc.2020.05.002. Epub 2020 May 8.

    PubMed 32437820

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Best Practice and Low Dose Radiation Therapy in people with Pneumonia and Severe Acute Respiratory Syndrome, run by Emory University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to clinical recovery (time frame: Up to follow-up day 14 after study start). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04433949, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023; AzTrials last refreshed its copy on 31 Oct 2026.

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