Phase 1-2 clinical study of feasibility and safety of 0.5 Gy radiotherapy to both lungs on moderate to severe cases of COVID-19 pneumonia
Settings and conduct
Patients are selected in multi- disciplinary team and will receive low dose RT in Imam Hossein Hospital in conjunction with standard treatment. The clinical course and biochemical parameters of inflammation are carefully monitored for 28 days post treatment.
Participants/Inclusion and exclusion criteria
Confirmed COVID-19 diagnosis ( PCR or serologic)
Presence of pulmonary involvement ( defined by P/F ratio or NIV need)
Less than 3 days since the onset of ARDS
Age > 60 years
Intervention groups
all patients due to inclusion criteria receive standard national protocol of COVID-19 treatment plus low dose radiotherapy to both lungs.
Main outcome variables
Change in clinical condition:
ICU stay
Hospital stay
Intubation / Extubation event
Change in pulmonary functions:
P/F ratio
PaO2
Change in radiologic findings:
CXR
Chest CT
Change in serum inflammation markers:
IL-6
CRP
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200509047366N1
Registration date:2020-05-12, 1399/02/23
Registration timing:prospective
Last update:2020-05-12, 1399/02/23
Update count:0
Registration date
2020-05-12, 1399/02/23
Registrant information
Name
Nazanin Rahnama
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2273 1056
Email address
nazanin.rahnama@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of adding low dose pulmonary radiotherapy to the national protocol of COVID-19 management: A pilot trial.
Public title
Radiotherapy in COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmed COVID-19 diagnosis ( PCR or serologic)
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
Age
From 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
5
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Vice-Chancellor in Research Affairs - Shahid Beheshti University of Medical Scie