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

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.

Active, not recruiting
COVID
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
All
Eligibility Age
Minimum: 60 Years
Countries
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
Keywords
Low Dose Lung Radiotherapy
Covid-19
Anti-inflammatory
MeSH Terms
Severe Acute Respiratory Syndrome
Coronavirus Infections