Official Title
Assessment of Adding Low Dose Pulmonary Radiotherapy to the National Protocol of COVID-19 Management: A Pilot Trial
Brief Summary

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.

Detailed 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


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.

Active, not recruiting
SARS (Severe Acute Respiratory Syndrome)

Radiation: Low Dose Radiotherapy
0.5 Gy radiation to both lungs in an AP/PA treatment plan
Low Dose Radiotherapy

Eligibility Criteria

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

Eligibility Gender
Eligibility Age
Minimum: 60 Years
Iran, Islamic Republic of

Ahmad Ameri, Prof.
Study Chair
Shahid Beheshti University of Medical Sciences


Nazanin Rahnama, M.D.
Principal Investigator
Shahid Beheshti University of Medical Sciences

Shahid Beheshti University of Medical Sciences
NCT Number
Low Dose Lung Radiotherapy
MeSH Terms
Severe Acute Respiratory Syndrome
Coronavirus Infections