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

NCT04433949 | Unknown Phase 3 DMC FDA Device

• 4 other identifiers: STUDY00000781NCI-2020-04061RAD5049-20P30CA138292
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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 radiographic appearance of their lungs, or their laboratory blood tests.

Conditions

Pneumonia; Severe Acute Respiratory Syndrome; Symptomatic COVID-19 Infection Laboratory-Confirmed

Keywords

Radiotherapy; COVID-19; low dose radiotherapy; anti-inflammatory; cytokine storm

Outcome Measures

Primary Outcomes (1)

• Time to clinical recovery

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

  Up to follow-up day 14 after study start

Secondary Outcomes (36)

• Freedom from ICU admission

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

• Temperature

  Up to follow-up day 14 after study start

• Heart rate

  Up to follow-up day 14 after study start

• Systolic Blood pressure

  Up to follow-up day 14 after study start

• Oxygen saturation

  Up to follow-up day 14 after study start

Study Arms (2)

Arm I (physician choice)

ACTIVE COMPARATOR

Patients get best supportive care + physician choice of treatment

Other: Best Practice

Arm II (LDRT)

EXPERIMENTAL

Patients receive best supportive care + low dose RT (whole lung)

Radiation: Low Dose Radiation Therapy

Interventions

Best Practice OTHER

Receive standard of care

Also known as: standard of care, standard therapy

Arm I (physician choice)

Low Dose Radiation Therapy RADIATION

Undergo LDRT

Also known as: Low Dose Radiation

Arm II (LDRT)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Pregnant and/or planned to be pregnant within in next 6 months
• Age 49 or younger at time of enrollment
• Prior enrollment on a separate COVID-19-related therapeutric trial (subsequent co-enrollment is permitted for patinets randomized to the control arm).

Sponsors & Collaborators

• Emory University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Related Publications (2)

• 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.

  PMID: 32373721 BACKGROUND

• 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.

  PMID: 32437820 BACKGROUND

Related Links

• Interim Results from the phase 1, 2 pilot safety trial of LD-RT for COVID
• Article on Forbes

MeSH Terms

Conditions

Pneumonia; Severe Acute Respiratory Syndrome; COVID-19; Cytokine Release Syndrome

Interventions

Practice Guidelines as Topic; Standard of Care; Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Pneumonia, Viral; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Therapeutics; Physical Phenomena

Study Officials

• Mohammad K Khan, MD, PhD

  Emory University Hospital/Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: June 16, 2020
• Study Start: June 23, 2020
• Primary Completion: October 19, 2022
• Study Completion: May 30, 2024
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)