Low Dose Radiotherapy in COVID-19 Pneumonia

Shahid Beheshti University of Medical Sciences

Status and phase: Unknown; Phase 2; Phase 1

Conditions: SARS (Severe Acute Respiratory Syndrome); COVID

Treatments: Radiation: Low Dose Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04390412

IRCT20200509047366N1 (Registry Identifier)

23568

Details and patient eligibility

About

Moderate to severe cases of SARS-associated ARDS based on inclusion/ exclusion criteria and the decision made in multi- disciplinary team are treated with 0.5 Gy whole lung radiation.

Full description

SARS-associated ARDS (acute respiratory distress syndrome) is the most fatal outcome of COVID-19 systemic infection. To overcome the uncontrolled inflammation leading to ARDS and respiratory failure, several drugs have been investigated in this situation with the most promising results coming from anti-inflammatory agents that directly or indirectly inhibit IL-6 and its counterparts of inflammation.

Low dose radiation, as opposed to high dose, has documented anti-inflammatory effects that are exercised through various mechanisms including decrease in pro-inflammatory cytokines such as IL-6.

In this pilot clinical trial, the patients are carefully selected according to inclusion /exclusion criteria and the clinical judgement of the multi- disciplinary team.Their diagnostic CT scan will be used to plan an AP/ PA radiotherapy treatment to both lungs and the set-up positioning information is obtained from anatomical landmarks. The patient will be referred for a fraction of 0.5 Gy to both lungs and for the next 28 days the clinical para-clinical and radiologic variables of disease severity will be monitored closely. Should the patient's clinical course indicate and the multi- disciplinary team approves, they may be subjected to another fraction of 0.5 Gy to a maximum of 1 Gy in two fractions at least 72 hours apart. All the patients will also receive the standard national protocol of COVID-19 management.

A total of 5 patients will be enrolled in the RT arm, providing favourable results seen in the first set of patients, the team will decide on recruiting a larger number for a phase II clinical trial.

Enrollment: 5 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed COVID-19 diagnosis ( PCR or serologic or radiographic)
• Presence of pulmonary involvement ( defined by P/F ratio or NIV need)
• Less than 3 days since the onset of ARDS
• Age > 60 years
• ↑ IL-6 ( if available)
• ↑ CRP

Exclusion criteria

• Lack of informed consent
• Inability to transfer to the radiation unit
• Hemodynamic instability
• Septic shock and organ dysfunction
• Severe ARDS P/F ratio ≤ 100 mmHg
• History of cardiac failure
• Contraindications to radiation

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Low Dose Radiotherapy

Experimental group

Description:

0.5 Gy radiation to both lungs in an AP/PA fashion

Treatment:

Radiation: Low Dose Radiotherapy