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.
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.
Radiation: Low Dose Radiotherapy
0.5 Gy radiation to both lungs in an AP/PA treatment plan
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
Imam Hossein Hospital
Tehran, Iran, Islamic Republic of