PneumoniaPhase 1/2RESCUE 1-19NCT04366791
Radiation Eliminates Storming Cytokines and Unchecked Edema as a 1-Day Treatment for COVID-19
A Phase 1/2 study testing Low Dose Radiation Therapy in people with Pneumonia and Coronavirus Infection in 2019 (COVID-19), run by Emory University at 2 sites in United States.
Trial summary
This phase I/II trial studies low-dose radiation therapy as a focal anti-inflammatory treatment for patients with pneumonia or SARS associated with COVID-19 infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Coronavirus Infection in 2019 (COVID-19), Severe Acute Respiratory Syndrome (SARS) Pneumonia
- What is being tested?
- Low Dose Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Apr 2020to 11 Mar 2022
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have had a positive test confirming the diagnosis of COVID-19
- Have had clinical signs of severe acute respiratory syndrome or pneumonia (dyspnea, cough, with need for oxygen support at the time of enrollment)
- Have visible consolidations/ground glass opacities on chest x-ray or computed tomography
- Have received pre-intubation respiratory support or undergone endotracheal intubation and have been on ventilator support for no longer than 5 (five) calendar days prior to the schedule date of delivery of low-dose radiation therapy.
- 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
- No use of disallowed medications 1 day prior to delivery of LDRT: Azithromycin, chloroquine, hydrochloroquine, COVID-targeted antiviral medications
- Pregnant and/or planned to be pregnant within in next 6 months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory University Hospital Midtown/Winship Cancer Institute
Atlanta, Georgia, 30308
Emory Saint Joseph's Hosptial
Atlanta, Georgia, 30342
About this study
Official title: The RESCUE 1-19 Trial: Radiation Eliminates Storming Cytokines and Unchecked Edema as a 1-Day Treatment for COVID-19
This phase I/II trial studies low-dose radiation therapy as a focal anti-inflammatory treatment for patients with pneumonia or SARS associated with COVID-19 infection.
Read the detailed description
PRIMARY OBJECTIVE:
- To compare treatment of COVID-19 between best supportive care plus provider's treatment choice versus best supportive care plus low-dose, whole-lung radiation therapy
OUTLINE:
Patients undergo 1 fraction of low-dose radiation therapy.
After completion of study treatment, patients are followed up at days 1-7, and 14 after last dose of intervention.
- Conditions
- Pneumonia, Coronavirus Infection in 2019 (COVID-19), Severe Acute Respiratory Syndrome (SARS) Pneumonia
- Being tested
- Low Dose Radiation Therapy
- Medical subject headings
- Pneumonia, COVID-19, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose Radiation TherapyRadiation
Also called Low Dose Radiation
Undergo low-dose radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (low-dose radiation therapy) | Experimental | Patients undergo 1 fraction of low-dose radiation therapy. Receives: Radiation: Low Dose Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of extubation (for intubated patients)
The rate will be reported, along with a two-sided 95% exact binomial confidence interval, using the Clopper-Pearson method. The observed extubation rate will be compared to the null rate of 20% using a two-sided binomial test. Statistical significance is assessed at the 0.05 level.
Measured: Screening up to 28 days after radiation therapy
Secondary outcomes (41)
Clinical outcome - Temperature
Temperature in degrees (F)
Measured: Screening up to 28 days after radiation therapy
Clinical outcome - Heart Rate
Heart rate in beats per minutes
Measured: Screening up to 28 days after radiation therapy
Clinical outcome - Systolic blood pressure
Systolic blood pressure in mm Hg
Measured: Screening up to 28 days after radiation therapy
Clinical outcome - Oxygenation
Oxygen saturation in percentage
Measured: Screening up to 28 days after radiation therapy
Clinical outcome - Respirations
Respiratory rate in breaths per minute
Measured: Screening up to 28 days after radiation therapy
Clinical outcome - FiO2
FI02 in percentage
Measured: Screening up to 28 days after radiation therapy
Clinical outcome - PEEP
Positive end expiratory pressure (PEEP) in cm H20
Measured: Screening up to 28 days after radiation therapy
Clinical outcome - Tidal volume
Tidal volume in mL
Measured: Screening up to 28 days after radiation therapy
Clinical outcome - Intubation/Extubation events
Extubation/intubation events in percentage
Measured: Screening up to 28 days after radiation therapy
Clinical outcome - Overall survival
Survival in percentage
Measured: Screening up to 28 days after radiation therapy
Radiographic outcome - Chest xray
Serial chest x-rays categorized using published scale into ordinal ranks 1-5 for SARS.
Measured: Screening up to 28 days after radiation therapy
Radiographic outcome - CT can
CT scans with volume of consolidation measured in cubic centimeters.
Measured: Screening up to 28 days after radiation therapy
Serologic outcome - WBC
White blood cell count in cell count x 10^3/mcL
Measured: Screening up to 28 days after radiation therapy
Serologic outcome - Hgb
Hemoglobin in gm/dL
Measured: Screening up to 28 days after radiation therapy
Serologic outcome - Procalcitonin
Procalcitonin in ng/mL
Measured: Screening up to 28 days after radiation therapy
Serologic outcome - ANC
Absolute neutrophil count in cell count x 10^3/mcL
Measured: Screening up to 28 days after radiation therapy
Serologic outcome - Creatine kinase
Creatine kinase in units/L
Measured: Screening up to 28 days after radiation therapy
Serologic outcome - Myoglobin
Myoglobin in ng/mL
Measured: Screening up to 28 days after radiation therapy
Serologic outcome - Albumin
Albumin in gm/dL
Measured: Screening up to 28 days after radiation therapy
Serologic outcome - PT/PTT
Coagulation pathway time in seconds
Measured: Screening up to 28 days after radiation therapy
Serologic outcome - D-Dimer
D-Dimer in ng/mL
Measured: Screening up to 28 days after radiation therapy
Serologic outcome - GGT
Gamma-glutamyl transferase in units/L
Measured: Screening up to 28 days after radiation therapy
Serologic outcome -Triglycerides
Trygliciericdes in mg/dL
Measured: Screening up to 28 days after radiation therapy
Serologic outcome -Ferritin
Ferritin in ng/mL
Measured: Screening up to 28 days after radiation therapy
Serologic outcome -Fibrinogen
Fibrinogen in mg/dL
Measured: Screening up to 28 days after radiation therapy
Serologic Immune markers flow cytometry
Immune marker flow cytometry (refractive index)
Measured: Screening up to 28 days after radiation therapy
Serologic outcome -Bilirubin
Bilirubin in mg/dL
Measured: Screening up to 28 days after radiation therapy
Serologic outcome - LDH
Lactate Dehydrogenase in units/L
Measured: Screening up to 28 days after radiation therapy
Serologic outcome - Creatinine
Creatinine in mg/dL
Measured: Screening up to 28 days after radiation therapy
Serologic outcome - EGFR
Estimated Glomerular Filtration Rate in mL/min/m2
Measured: Screening up to 28 days after radiation therapy
Serologic outcome - CRP
C-Reactive Protein in mg/L
Measured: Screening up to 28 days after radiation therapy
Serologic outcome - ALT
Alanine Aminotransferase in units/L
Measured: Screening up to 28 days after radiation therapy
Serologic outcome - AST
Asparatate Aminotransferase in units/L
Measured: Screening up to 28 days after radiation therapy
Serologic outcome - Troponin-I
Troponin-I in ng/mL
Measured: Screening up to 28 days after radiation therapy
Serologic outcome - BNP
B-Natriuretic Peptid in pg/mL
Measured: Screening up to 28 days after radiation therapy
Serologic outcome - Blood Gases pH
pH (no unit)
Measured: Screening up to 28 days after radiation therapy
Serologic outcome - Blood Gases pO2
pressure of O2 in mm Hg
Measured: Screening up to 28 days after radiation therapy
Serologic outcome - Blood Gases pCO2
pressure of CO2 in mm Hg
Measured: Screening up to 28 days after radiation therapy
Serologic outcome - Lactic Acid
Lactic Acid in mmol/L
Measured: Screening up to 28 days after radiation therapy
Serologic outcome - IL-6
Interleukin-6 in pg/mL
Measured: Screening up to 28 days after radiation therapy
Serologic outcome - Potassium
Potassium in mmol/L
Measured: Screening up to 28 days after radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start24 Apr 2020
- Primary completion11 Mar 2022
- Study completion11 Mar 2022
Why it stopped: PI does not plan on putting any new patients on study. All patients completed this trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Mohammad K. Khan, Emory University
- Investigators
- Mohammad Khan, MD, PhD, Principal investigator, Emory University Hospital/Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366791
- Sponsor's protocol ID
- STUDY00000476
- Other IDs
- NCI-2020-02676, RAD5002-20, P30CA138292
- Acronym
- RESCUE 1-19
- Status last verified
- Mar 2022
- First submitted
- 24 Apr 2020
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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
Hess CB, Eng TY, Nasti TH, Dhere VR, Kleber TJ, Switchenko JM, Weinberg BD, Rouphael N, Tian S, Rudra S, Taverna LS, Daisson AP, Ahmed R, Khan MK. Whole-lung low-dose radiation therapy (LD-RT) for non-intubated oxygen-dependent patients with COVID-19-related pneumonia receiving dexamethasone and/or remdesevir. Radiother Oncol. 2021 Dec;165:20-31. doi: 10.1016/j.radonc.2021.10.003. Epub 2021 Oct 13.
PubMed 34653525
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The RESCUE 1-19 Trial: Radiation Eliminates Storming Cytokines and Unchecked Edema as a 1-Day Treatment for COVID-19
- ClinicalTrials.gov ID
- NCT04366791
- Acronym / sponsor ID
- RESCUE 1-19 / STUDY00000476
- Conditions
- Pneumonia, Coronavirus Infection in 2019 (COVID-19), Severe Acute Respiratory Syndrome (SARS) Pneumonia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI does not plan on putting any new patients on study. All patients completed this trial.
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 Apr 2020 (actual)
- Primary completion
- 11 Mar 2022 (actual)
- Study completion
- 11 Mar 2022 (actual)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase I/II trial studies low-dose radiation therapy as a focal anti-inflammatory treatment for patients with pneumonia or SARS associated with COVID-19 infection.
Detailed description
PRIMARY OBJECTIVE:
- To compare treatment of COVID-19 between best supportive care plus provider's treatment choice versus best supportive care plus low-dose, whole-lung radiation therapy
OUTLINE:
Patients undergo 1 fraction of low-dose radiation therapy.
After completion of study treatment, patients are followed up at days 1-7, and 14 after last dose of intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (low-dose radiation therapy) | Experimental | Radiation: Low Dose Radiation TherapyPatients undergo 1 fraction of low-dose radiation therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have had a positive test confirming the diagnosis of COVID-19
- Have had clinical signs of severe acute respiratory syndrome or pneumonia (dyspnea, cough, with need for oxygen support at the time of enrollment)
- Have visible consolidations/ground glass opacities on chest x-ray or computed tomography
- Have received pre-intubation respiratory support or undergone endotracheal intubation and have been on ventilator support for no longer than 5 (five) calendar days prior to the schedule date of delivery of low-dose radiation therapy.
- Willingness and ability of the subject to comply with scheduled visits, protocol-specified laboratory tests, other study procedures, and study restrictions
Key exclusion criteria (2 listed)
- No use of disallowed medications 1 day prior to delivery of LDRT: Azithromycin, chloroquine, hydrochloroquine, COVID-targeted antiviral medications
- Pregnant and/or planned to be pregnant within in next 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Dose Radiation TherapyAlso: Low Dose RadiationUndergo low-dose radiation therapy | Radiation | Supportive care (low-dose radiation therapy) |
Primary outcome
Rate of extubation (for intubated patients)
Time frame: Screening up to 28 days after radiation therapy
The rate will be reported, along with a two-sided 95% exact binomial confidence interval, using the Clopper-Pearson method. The observed extubation rate will be compared to the null rate of 20% using a two-sided binomial test. Statistical significance is assessed at the 0.05 level.
41 secondary outcomes
Clinical outcome - Temperature
Time frame: Screening up to 28 days after radiation therapy
Clinical outcome - Heart Rate
Time frame: Screening up to 28 days after radiation therapy
Clinical outcome - Systolic blood pressure
Time frame: Screening up to 28 days after radiation therapy
Clinical outcome - Oxygenation
Time frame: Screening up to 28 days after radiation therapy
Clinical outcome - Respirations
Time frame: Screening up to 28 days after radiation therapy
Clinical outcome - FiO2
Time frame: Screening up to 28 days after radiation therapy
Clinical outcome - PEEP
Time frame: Screening up to 28 days after radiation therapy
Clinical outcome - Tidal volume
Time frame: Screening up to 28 days after radiation therapy
Clinical outcome - Intubation/Extubation events
Time frame: Screening up to 28 days after radiation therapy
Clinical outcome - Overall survival
Time frame: Screening up to 28 days after radiation therapy
Radiographic outcome - Chest xray
Time frame: Screening up to 28 days after radiation therapy
Radiographic outcome - CT can
Time frame: Screening up to 28 days after radiation therapy
Serologic outcome - WBC
Time frame: Screening up to 28 days after radiation therapy
Serologic outcome - Hgb
Time frame: Screening up to 28 days after radiation therapy
Serologic outcome - Procalcitonin
Time frame: Screening up to 28 days after radiation therapy
Serologic outcome - ANC
Time frame: Screening up to 28 days after radiation therapy
Serologic outcome - Creatine kinase
Time frame: Screening up to 28 days after radiation therapy
Serologic outcome - Myoglobin
Time frame: Screening up to 28 days after radiation therapy
Serologic outcome - Albumin
Time frame: Screening up to 28 days after radiation therapy
Serologic outcome - PT/PTT
Time frame: Screening up to 28 days after radiation therapy
Serologic outcome - D-Dimer
Time frame: Screening up to 28 days after radiation therapy
Serologic outcome - GGT
Time frame: Screening up to 28 days after radiation therapy
Serologic outcome -Triglycerides
Time frame: Screening up to 28 days after radiation therapy
Serologic outcome -Ferritin
Time frame: Screening up to 28 days after radiation therapy
Serologic outcome -Fibrinogen
Time frame: Screening up to 28 days after radiation therapy
Serologic Immune markers flow cytometry
Time frame: Screening up to 28 days after radiation therapy
Serologic outcome -Bilirubin
Time frame: Screening up to 28 days after radiation therapy
Serologic outcome - LDH
Time frame: Screening up to 28 days after radiation therapy
Serologic outcome - Creatinine
Time frame: Screening up to 28 days after radiation therapy
Serologic outcome - EGFR
Time frame: Screening up to 28 days after radiation therapy
Serologic outcome - CRP
Time frame: Screening up to 28 days after radiation therapy
Serologic outcome - ALT
Time frame: Screening up to 28 days after radiation therapy
Serologic outcome - AST
Time frame: Screening up to 28 days after radiation therapy
Serologic outcome - Troponin-I
Time frame: Screening up to 28 days after radiation therapy
Serologic outcome - BNP
Time frame: Screening up to 28 days after radiation therapy
Serologic outcome - Blood Gases pH
Time frame: Screening up to 28 days after radiation therapy
Serologic outcome - Blood Gases pO2
Time frame: Screening up to 28 days after radiation therapy
Serologic outcome - Blood Gases pCO2
Time frame: Screening up to 28 days after radiation therapy
Serologic outcome - Lactic Acid
Time frame: Screening up to 28 days after radiation therapy
Serologic outcome - IL-6
Time frame: Screening up to 28 days after radiation therapy
Results and safety
The study was stopped early (reason given: PI does not plan on putting any new patients on study. All patients completed this trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Derived from this study: PubMed 34653525Hess CB, Eng TY, Nasti TH, Dhere VR, Kleber TJ, Switchenko JM, Weinberg BD, Rouphael N, Tian S, Rudra S, Taverna LS, Daisson AP, Ahmed R, Khan MK. Whole-lung low-dose radiation therapy (LD-RT) for non-intubated oxygen-dependent patients with COVID-19-related pneumonia receiving dexamethasone and/or remdesevir. Radiother Oncol. 2021 Dec;165:20-31. doi: 10.1016/j.radonc.2021.10.003. Epub 2021 Oct 13.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad Khan, MD, PhD principal investigator
Emory University Hospital/Winship Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Low Dose Radiation Therapy in people with Pneumonia and Coronavirus Infection in 2019 (COVID-19), run by Emory University at 2 sites 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 6 inclusion and 2 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: stopped early, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: PI does not plan on putting any new patients on study. All patients completed this trial.). 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?
Rate of extubation (for intubated patients) (time frame: Screening up to 28 days after radiation therapy). 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 NCT04366791, which also lists 1 linked publication.
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 29 Mar 2022.