COVID, SARS (Severe Acute Respiratory Syndrome)
Conditions
Keywords
Low Dose Lung Radiotherapy, COVID-19, anti-inflammatory
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.
Interventions
RADIATIONLow Dose Radiotherapy
0.5 Gy radiation to both lungs in an AP/PA treatment plan
Sponsors
Shahid Beheshti University of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of intubation events | 28 days | Total number of intubations performed after the treatment |
| Change from baseline blood oxygenation | 28 days | O2 saturation |
| Number of Hospital stay days | 28 days | Total days the patient is admitted to hospital |
| Number of ICU stay days | 28 days | Total days the patient is admitted to ICU |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| WBC | 28 days | Changes in WBC count if base-line is abnormal |
| Platelets | 28 days | Changes in Platelets count if base-line is abnormal |
| CRP | Day 1 | Changes in CRP serum level |
| IL-6 | Day 1 | Changes in IL-6 serum level |
Countries
Iran
Outcome results
None listed