Low Dose Radiotherapy in COVID-19 Pneumonia
- Conditions
- COVIDSARS (Severe Acute Respiratory Syndrome)
- Interventions
- Radiation: Low Dose Radiotherapy
- Registration Number
- NCT04390412
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 5
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Low Dose Radiotherapy Low Dose Radiotherapy 0.5 Gy radiation to both lungs in an AP/PA fashion
- Primary Outcome Measures
Name Time Method 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
Number of intubation events 28 days Total number of intubations performed after the treatment
- Secondary Outcome Measures
Name Time Method WBC 28 days Changes in WBC count if base-line is abnormal
CRP Day 5 Changes in CRP serum level
IL-6 Day 5 Changes in IL-6 serum level
Platelets 28 days Changes in Platelets count if base-line is abnormal
Trial Locations
- Locations (1)
Imam Hossein Hospital
🇮🇷Tehran, Iran, Islamic Republic of