Created at Source Raw Value Validated value
June 25, 2024, noon usa

1. severe background disease like severe cardiac or pulmonary insufficiency (who grade iii or iv), severe liver and kidney diseases, severe copd, severe neurological disease, or concurrent malignancy (other than non-melanoma skin cancer) which is uncontrolled or actively being treated 2. severe asthma on chronic therapy with biologics or steroids. 3. prior malignancy in which any thoracic radiotherapy was administered except for partial or tangent breast irradiation for early-stage (stages i or ii) breast cancer 4. d-dimer levels of \>2,000 ng/ml at screening 5. use of anti-pulmonary fibrosis drugs (e.g., imatinib, nintedanib, pirfenidone, penicillamine, colchicine, tumor necrosis factor alpha blocker) within 5 days of the first scheduled day of study intervention dosing 6. use of anti-cytokine release syndrome drugs (e.g., anakinra, sarilumab, siltuximab, tocilizumab and/or lenzilumab) within 5 days of the first scheduled day of study intervention dosing 7. use of systemic corticosteroids (e.g., prednisone, dexamethasone) within 5 days of the first scheduled day of study intervention dosing 8. an active infection or infection with a fever ≥ 38.5°c within 3 days of the first scheduled day of study intervention dosing 9. poorly controlled intercurrent illnesses, such as interstitial lung disease, uncontrolled hypertension; poorly controlled diabetes mellitus; unstable angina, myocardial infarction, acute coronary syndrome or cerebrovascular event within 6 months of screening; history of congestive heart failure (nyha class iii or iv); severe valvular heart disease; or poorly controlled cardiac arrhythmias not responding to medical therapy or a pacemaker 10. qtc with fridericia's correction that is unmeasurable, or ≥480 msec on screening ecg. the average qtc from the screening ecg (completed in triplicate) must be \<480 msec for the patient to be eligible for the study 11. patients taking any concomitant medication that may cause qtc prolongation, induce torsades de pointes (www.crediblemeds.org) are not eligible if qtc ≥460 msec 12. patients who have undergone thoracotomy within 4 weeks of day 1 of protocol therapy 13. patients that have a known allergy to any of the placebo components 14. psychiatric conditions, social situations or substance abuse that precludes the ability of the study participant to cooperate with the requirements of the trial and protocol therapy 15. pregnancy or currently on estrogen-based contraceptives 16. women who are breastfeeding 17. past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

1. severe background disease like severe cardiac or pulmonary insufficiency (who grade iii or iv), severe liver and kidney diseases, severe copd, severe neurological disease, or concurrent malignancy (other than non-melanoma skin cancer) which is uncontrolled or actively being treated 2. severe asthma on chronic therapy with biologics or steroids. 3. prior malignancy in which any thoracic radiotherapy was administered except for partial or tangent breast irradiation for early-stage (stages i or ii) breast cancer 4. d-dimer levels of \>2,000 ng/ml at screening 5. use of anti-pulmonary fibrosis drugs (e.g., imatinib, nintedanib, pirfenidone, penicillamine, colchicine, tumor necrosis factor alpha blocker) within 5 days of the first scheduled day of study intervention dosing 6. use of anti-cytokine release syndrome drugs (e.g., anakinra, sarilumab, siltuximab, tocilizumab and/or lenzilumab) within 5 days of the first scheduled day of study intervention dosing 7. use of systemic corticosteroids (e.g., prednisone, dexamethasone) within 5 days of the first scheduled day of study intervention dosing 8. an active infection or infection with a fever ≥ 38.5°c within 3 days of the first scheduled day of study intervention dosing 9. poorly controlled intercurrent illnesses, such as interstitial lung disease, uncontrolled hypertension; poorly controlled diabetes mellitus; unstable angina, myocardial infarction, acute coronary syndrome or cerebrovascular event within 6 months of screening; history of congestive heart failure (nyha class iii or iv); severe valvular heart disease; or poorly controlled cardiac arrhythmias not responding to medical therapy or a pacemaker 10. qtc with fridericia's correction that is unmeasurable, or ≥480 msec on screening ecg. the average qtc from the screening ecg (completed in triplicate) must be \<480 msec for the patient to be eligible for the study 11. patients taking any concomitant medication that may cause qtc prolongation, induce torsades de pointes (www.crediblemeds.org) are not eligible if qtc ≥460 msec 12. patients who have undergone thoracotomy within 4 weeks of day 1 of protocol therapy 13. patients that have a known allergy to any of the placebo components 14. psychiatric conditions, social situations or substance abuse that precludes the ability of the study participant to cooperate with the requirements of the trial and protocol therapy 15. pregnancy or currently on estrogen-based contraceptives 16. women who are breastfeeding 17. past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

Nov. 16, 2021, 6:30 p.m. usa

severe background disease like severe cardiac or pulmonary insufficiency (who grade iii or iv), severe liver and kidney diseases, severe copd, severe neurological disease, or concurrent malignancy (other than non-melanoma skin cancer) which is uncontrolled or actively being treated severe asthma on chronic therapy with biologics or steroids. prior malignancy in which any thoracic radiotherapy was administered except for partial or tangent breast irradiation for early-stage (stages i or ii) breast cancer d-dimer levels of >2,000 ng/ml at screening use of anti-pulmonary fibrosis drugs (e.g., imatinib, nintedanib, pirfenidone, penicillamine, colchicine, tumor necrosis factor alpha blocker) within 5 days of the first scheduled day of study intervention dosing use of anti-cytokine release syndrome drugs (e.g., anakinra, sarilumab, siltuximab, tocilizumab and/or lenzilumab) within 5 days of the first scheduled day of study intervention dosing use of systemic corticosteroids (e.g., prednisone, dexamethasone) within 5 days of the first scheduled day of study intervention dosing an active infection or infection with a fever ≥ 38.5°c within 3 days of the first scheduled day of study intervention dosing poorly controlled intercurrent illnesses, such as interstitial lung disease, uncontrolled hypertension; poorly controlled diabetes mellitus; unstable angina, myocardial infarction, acute coronary syndrome or cerebrovascular event within 6 months of screening; history of congestive heart failure (nyha class iii or iv); severe valvular heart disease; or poorly controlled cardiac arrhythmias not responding to medical therapy or a pacemaker qtc with fridericia's correction that is unmeasurable, or ≥480 msec on screening ecg. the average qtc from the screening ecg (completed in triplicate) must be <480 msec for the patient to be eligible for the study patients taking any concomitant medication that may cause qtc prolongation, induce torsades de pointes (www.crediblemeds.org) are not eligible if qtc ≥460 msec patients who have undergone thoracotomy within 4 weeks of day 1 of protocol therapy patients that have a known allergy to any of the placebo components psychiatric conditions, social situations or substance abuse that precludes the ability of the study participant to cooperate with the requirements of the trial and protocol therapy pregnancy or currently on estrogen-based contraceptives women who are breastfeeding past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

severe background disease like severe cardiac or pulmonary insufficiency (who grade iii or iv), severe liver and kidney diseases, severe copd, severe neurological disease, or concurrent malignancy (other than non-melanoma skin cancer) which is uncontrolled or actively being treated severe asthma on chronic therapy with biologics or steroids. prior malignancy in which any thoracic radiotherapy was administered except for partial or tangent breast irradiation for early-stage (stages i or ii) breast cancer d-dimer levels of >2,000 ng/ml at screening use of anti-pulmonary fibrosis drugs (e.g., imatinib, nintedanib, pirfenidone, penicillamine, colchicine, tumor necrosis factor alpha blocker) within 5 days of the first scheduled day of study intervention dosing use of anti-cytokine release syndrome drugs (e.g., anakinra, sarilumab, siltuximab, tocilizumab and/or lenzilumab) within 5 days of the first scheduled day of study intervention dosing use of systemic corticosteroids (e.g., prednisone, dexamethasone) within 5 days of the first scheduled day of study intervention dosing an active infection or infection with a fever ≥ 38.5°c within 3 days of the first scheduled day of study intervention dosing poorly controlled intercurrent illnesses, such as interstitial lung disease, uncontrolled hypertension; poorly controlled diabetes mellitus; unstable angina, myocardial infarction, acute coronary syndrome or cerebrovascular event within 6 months of screening; history of congestive heart failure (nyha class iii or iv); severe valvular heart disease; or poorly controlled cardiac arrhythmias not responding to medical therapy or a pacemaker qtc with fridericia's correction that is unmeasurable, or ≥480 msec on screening ecg. the average qtc from the screening ecg (completed in triplicate) must be <480 msec for the patient to be eligible for the study patients taking any concomitant medication that may cause qtc prolongation, induce torsades de pointes (www.crediblemeds.org) are not eligible if qtc ≥460 msec patients who have undergone thoracotomy within 4 weeks of day 1 of protocol therapy patients that have a known allergy to any of the placebo components psychiatric conditions, social situations or substance abuse that precludes the ability of the study participant to cooperate with the requirements of the trial and protocol therapy pregnancy or currently on estrogen-based contraceptives women who are breastfeeding past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

Aug. 23, 2021, 7 p.m. usa

1. severe background disease like severe cardiac or pulmonary insufficiency (who grade iii or iv), severe liver and kidney diseases, severe copd, severe neurological disease, or concurrent malignancy (other than non-melanoma skin cancer) which is uncontrolled or actively being treated 2. severe asthma on chronic therapy with biologics or steroids. 3. prior malignancy in which any thoracic radiotherapy was administered except for partial or tangent breast irradiation for early-stage (stages i or ii) breast cancer 4. d-dimer levels of >2,000 ng/ml at screening 5. use of anti-pulmonary fibrosis drugs (e.g., imatinib, nintedanib, pirfenidone, penicillamine, colchicine, tumor necrosis factor alpha blocker) within 5 days of the first scheduled day of study intervention dosing 6. use of anti-cytokine release syndrome drugs (e.g., anakinra, sarilumab, siltuximab, tocilizumab and/or lenzilumab) within 5 days of the first scheduled day of study intervention dosing 7. use of systemic corticosteroids (e.g., prednisone, dexamethasone) within 5 days of the first scheduled day of study intervention dosing 8. an active infection or infection with a fever ≥ 38.5°c within 3 days of the first scheduled day of study intervention dosing 9. poorly controlled intercurrent illnesses, such as interstitial lung disease, uncontrolled hypertension; poorly controlled diabetes mellitus; unstable angina, myocardial infarction, acute coronary syndrome or cerebrovascular event within 6 months of screening; history of congestive heart failure (nyha class iii or iv); severe valvular heart disease; or poorly controlled cardiac arrhythmias not responding to medical therapy or a pacemaker 10. qtc with fridericia's correction that is unmeasurable, or ≥480 msec on screening ecg. the average qtc from the screening ecg (completed in triplicate) must be <480 msec for the patient to be eligible for the study 11. patients taking any concomitant medication that may cause qtc prolongation, induce torsades de pointes (www.crediblemeds.org) are not eligible if qtc ≥460 msec 12. patients who have undergone thoracotomy within 4 weeks of day 1 of protocol therapy 13. patients that have a known allergy to any of the placebo components 14. psychiatric conditions, social situations or substance abuse that precludes the ability of the study participant to cooperate with the requirements of the trial and protocol therapy 15. pregnancy or currently on estrogen-based contraceptives 16. women who are breastfeeding 17. past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

1. severe background disease like severe cardiac or pulmonary insufficiency (who grade iii or iv), severe liver and kidney diseases, severe copd, severe neurological disease, or concurrent malignancy (other than non-melanoma skin cancer) which is uncontrolled or actively being treated 2. severe asthma on chronic therapy with biologics or steroids. 3. prior malignancy in which any thoracic radiotherapy was administered except for partial or tangent breast irradiation for early-stage (stages i or ii) breast cancer 4. d-dimer levels of >2,000 ng/ml at screening 5. use of anti-pulmonary fibrosis drugs (e.g., imatinib, nintedanib, pirfenidone, penicillamine, colchicine, tumor necrosis factor alpha blocker) within 5 days of the first scheduled day of study intervention dosing 6. use of anti-cytokine release syndrome drugs (e.g., anakinra, sarilumab, siltuximab, tocilizumab and/or lenzilumab) within 5 days of the first scheduled day of study intervention dosing 7. use of systemic corticosteroids (e.g., prednisone, dexamethasone) within 5 days of the first scheduled day of study intervention dosing 8. an active infection or infection with a fever ≥ 38.5°c within 3 days of the first scheduled day of study intervention dosing 9. poorly controlled intercurrent illnesses, such as interstitial lung disease, uncontrolled hypertension; poorly controlled diabetes mellitus; unstable angina, myocardial infarction, acute coronary syndrome or cerebrovascular event within 6 months of screening; history of congestive heart failure (nyha class iii or iv); severe valvular heart disease; or poorly controlled cardiac arrhythmias not responding to medical therapy or a pacemaker 10. qtc with fridericia's correction that is unmeasurable, or ≥480 msec on screening ecg. the average qtc from the screening ecg (completed in triplicate) must be <480 msec for the patient to be eligible for the study 11. patients taking any concomitant medication that may cause qtc prolongation, induce torsades de pointes (www.crediblemeds.org) are not eligible if qtc ≥460 msec 12. patients who have undergone thoracotomy within 4 weeks of day 1 of protocol therapy 13. patients that have a known allergy to any of the placebo components 14. psychiatric conditions, social situations or substance abuse that precludes the ability of the study participant to cooperate with the requirements of the trial and protocol therapy 15. pregnancy or currently on estrogen-based contraceptives 16. women who are breastfeeding 17. past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

Jan. 29, 2021, 12:31 a.m. usa

1. severe background disease like severe cardiac or pulmonary insufficiency (who grade iii or iv), severe liver and kidney diseases, severe copd, severe neurological disease, or concurrent malignancy (other than non-melanoma skin cancer) which is uncontrolled or actively being treated 2. severe asthma on chronic therapy with biologics or steroids. 3. prior malignancy in which any thoracic radiotherapy was administered except for partial or tangent breast irradiation for early-stage (stages i or ii) breast cancer 4. d-dimer levels of >2,000 ng/ml at screening 5. use of anti-pulmonary fibrosis drugs in the past 5 days, (e.g., imatinib, nintedanib, pirfenidone, penicillamine, colchicine, tumor necrosis factor alpha blocker) 6. use of anti-cytokine release syndrome drugs in the past 5 days (e.g., anakinra, sarilumab, siltuximab, tocilizumab and/or lenzilumab) 7. use of systemic corticosteroids (e.g., prednisone, dexamethasone) in the past 5 days 8. an active infection or infection with a fever ≥ 38.5°c within 3 days of the first scheduled day of dosing 9. poorly controlled intercurrent illnesses, such as interstitial lung disease, uncontrolled hypertension; poorly controlled diabetes mellitus; unstable angina, myocardial infarction, acute coronary syndrome or cerebrovascular event within 6 months of screening; history of congestive heart failure (nyha class iii or iv); severe valvular heart disease; or poorly controlled cardiac arrhythmias not responding to medical therapy or a pacemaker 10. qtc with fridericia's correction that is unmeasurable, or ≥480 msec on screening ecg. the average qtc from the screening ecg (completed in triplicate) must be <480 msec for the patient to be eligible for the study 11. patients taking any concomitant medication that may cause qtc prolongation, induce torsades de pointes (www.crediblemeds.org) are not eligible if qtc ≥460 msec 12. patients who have undergone thoracotomy within 4 weeks of day 1 of protocol therapy 13. patients that have a known allergy to any of the placebo components 14. psychiatric conditions, social situations or substance abuse that precludes the ability of the study participant to cooperate with the requirements of the trial and protocol therapy 15. pregnancy or currently on estrogen-based contraceptives 16. women who are breastfeeding 17. past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

1. severe background disease like severe cardiac or pulmonary insufficiency (who grade iii or iv), severe liver and kidney diseases, severe copd, severe neurological disease, or concurrent malignancy (other than non-melanoma skin cancer) which is uncontrolled or actively being treated 2. severe asthma on chronic therapy with biologics or steroids. 3. prior malignancy in which any thoracic radiotherapy was administered except for partial or tangent breast irradiation for early-stage (stages i or ii) breast cancer 4. d-dimer levels of >2,000 ng/ml at screening 5. use of anti-pulmonary fibrosis drugs in the past 5 days, (e.g., imatinib, nintedanib, pirfenidone, penicillamine, colchicine, tumor necrosis factor alpha blocker) 6. use of anti-cytokine release syndrome drugs in the past 5 days (e.g., anakinra, sarilumab, siltuximab, tocilizumab and/or lenzilumab) 7. use of systemic corticosteroids (e.g., prednisone, dexamethasone) in the past 5 days 8. an active infection or infection with a fever ≥ 38.5°c within 3 days of the first scheduled day of dosing 9. poorly controlled intercurrent illnesses, such as interstitial lung disease, uncontrolled hypertension; poorly controlled diabetes mellitus; unstable angina, myocardial infarction, acute coronary syndrome or cerebrovascular event within 6 months of screening; history of congestive heart failure (nyha class iii or iv); severe valvular heart disease; or poorly controlled cardiac arrhythmias not responding to medical therapy or a pacemaker 10. qtc with fridericia's correction that is unmeasurable, or ≥480 msec on screening ecg. the average qtc from the screening ecg (completed in triplicate) must be <480 msec for the patient to be eligible for the study 11. patients taking any concomitant medication that may cause qtc prolongation, induce torsades de pointes (www.crediblemeds.org) are not eligible if qtc ≥460 msec 12. patients who have undergone thoracotomy within 4 weeks of day 1 of protocol therapy 13. patients that have a known allergy to any of the placebo components 14. psychiatric conditions, social situations or substance abuse that precludes the ability of the study participant to cooperate with the requirements of the trial and protocol therapy 15. pregnancy or currently on estrogen-based contraceptives 16. women who are breastfeeding 17. past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

Nov. 19, 2020, 12:31 a.m. usa

1. severe background disease like severe cardiac or pulmonary insufficiency (who grade iii or iv), severe liver and kidney diseases, copd, neurological diseases, and cancer 2. severe asthma on chronic therapy with biologics or steroids. 3. prior malignancy in which any thoracic radiotherapy was administered except for partial or tangent breast irradiation for early-stage (stages i or ii) breast cancer 4. d-dimer levels of >2,000 ng/ml at screening 5. use of anti-pulmonary fibrosis drugs in the past 5 days, (e.g., imatinib, nintedanib, pirfenidone, penicillamine, colchicine, tumor necrosis factor alpha blocker) 6. use of anti-cytokine release syndrome drugs in the past 5 days (e.g., anakinra, sarilumab, siltuximab, tocilizumab and/or lenzilumab) 7. use of systemic corticosteroids (e.g., prednisone, dexamethasone) in the past 5 days 8. an active infection or infection with a fever ≥ 38.5°c within 3 days of the first scheduled day of dosing 9. poorly controlled intercurrent illnesses, such as interstitial lung disease, uncontrolled hypertension; poorly controlled diabetes mellitus; unstable angina, myocardial infarction, acute coronary syndrome or cerebrovascular event within 6 months of screening; history of congestive heart failure (nyha class iii or iv); severe valvular heart disease; or poorly controlled cardiac arrhythmias not responding to medical therapy or a pacemaker 10. qtc with fridericia's correction that is unmeasurable, or ≥480 msec on screening ecg. the average qtc from the screening ecg (completed in triplicate) must be <480 msec for the patient to be eligible for the study 11. patients taking any concomitant medication that may cause qtc prolongation, induce torsades de pointes (www.crediblemeds.org) are not eligible if qtc ≥460 msec 12. patients who have undergone thoracotomy within 4 weeks of day 1 of protocol therapy 13. patients that have a known allergy to any of the placebo components 14. psychiatric conditions, social situations or substance abuse that precludes the ability of the study participant to cooperate with the requirements of the trial and protocol therapy 15. pregnancy or currently on estrogen-based contraceptives 16. women who are breastfeeding 17. past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

1. severe background disease like severe cardiac or pulmonary insufficiency (who grade iii or iv), severe liver and kidney diseases, copd, neurological diseases, and cancer 2. severe asthma on chronic therapy with biologics or steroids. 3. prior malignancy in which any thoracic radiotherapy was administered except for partial or tangent breast irradiation for early-stage (stages i or ii) breast cancer 4. d-dimer levels of >2,000 ng/ml at screening 5. use of anti-pulmonary fibrosis drugs in the past 5 days, (e.g., imatinib, nintedanib, pirfenidone, penicillamine, colchicine, tumor necrosis factor alpha blocker) 6. use of anti-cytokine release syndrome drugs in the past 5 days (e.g., anakinra, sarilumab, siltuximab, tocilizumab and/or lenzilumab) 7. use of systemic corticosteroids (e.g., prednisone, dexamethasone) in the past 5 days 8. an active infection or infection with a fever ≥ 38.5°c within 3 days of the first scheduled day of dosing 9. poorly controlled intercurrent illnesses, such as interstitial lung disease, uncontrolled hypertension; poorly controlled diabetes mellitus; unstable angina, myocardial infarction, acute coronary syndrome or cerebrovascular event within 6 months of screening; history of congestive heart failure (nyha class iii or iv); severe valvular heart disease; or poorly controlled cardiac arrhythmias not responding to medical therapy or a pacemaker 10. qtc with fridericia's correction that is unmeasurable, or ≥480 msec on screening ecg. the average qtc from the screening ecg (completed in triplicate) must be <480 msec for the patient to be eligible for the study 11. patients taking any concomitant medication that may cause qtc prolongation, induce torsades de pointes (www.crediblemeds.org) are not eligible if qtc ≥460 msec 12. patients who have undergone thoracotomy within 4 weeks of day 1 of protocol therapy 13. patients that have a known allergy to any of the placebo components 14. psychiatric conditions, social situations or substance abuse that precludes the ability of the study participant to cooperate with the requirements of the trial and protocol therapy 15. pregnancy or currently on estrogen-based contraceptives 16. women who are breastfeeding 17. past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

Oct. 26, 2020, 11:31 p.m. usa

1. patients with severe background disease like severe cardiac or pulmonary insufficiency (who grade iii or iv), severe liver and kidney diseases, chronic obstructive pulmonary disease (copd), neurological diseases, and cancer 2. prior malignancy in which any thoracic radiotherapy was administered except for partial or tangent breast irradiation for early-stage (stages i or ii) breast cancer 3. d-dimer levels of >2,000 ng/ml at screening 4. use of anti-pulmonary fibrosis drugs in the past 14 days, (e.g., imatinib, nintedanib, pirfenidone, penicillamine, colchicine, tumor necrosis factor alpha blocker) 5. use of anti-cytokine release syndrome drugs in the past 5 days (anakinra, sarilumab, siltuximab, tocilizumab and/or lenzilumab) 6. use of biologics (omalizumab, mepolizumab, reslizumab, benralizumab and dupilumab) to treat asthma in the past 14 days 7. use of systemic corticosteroids (e.g., prednisone) in the past 5 days 8. an active infection or infection with a fever ≥ 38.5°c within 3 days of the first scheduled day of dosing 9. poorly controlled intercurrent illnesses, such as interstitial lung disease, uncontrolled hypertension; poorly controlled diabetes mellitus; unstable angina, myocardial infarction, acute coronary syndrome or cerebrovascular event within 6 months of screening; history of congestive heart failure (nyha class iii or iv); severe valvular heart disease; or poorly controlled cardiac arrhythmias not responding to medical therapy or a pacemaker 10. qtc with fridericia's correction that is unmeasurable, or ≥480 msec on screening ecg. the average corrected qt interval (qtc) from the screening ecg (completed in triplicate) must be <480 msec for the patient to be eligible for the study 11. participants taking any concomitant medication that may cause qtc prolongation, induce torsades de pointes are not eligible if qtc ≥460 msec 12. patients who have undergone thoracotomy within 4 weeks of day 1 of protocol therapy 13. patients that have a known allergy to any of the placebo components 14. psychiatric conditions, social situations or substance abuse that precludes the ability of the study participant to cooperate with the requirements of the trial and protocol therapy 15. pregnancy 16. women who are breastfeeding 17. past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

1. patients with severe background disease like severe cardiac or pulmonary insufficiency (who grade iii or iv), severe liver and kidney diseases, chronic obstructive pulmonary disease (copd), neurological diseases, and cancer 2. prior malignancy in which any thoracic radiotherapy was administered except for partial or tangent breast irradiation for early-stage (stages i or ii) breast cancer 3. d-dimer levels of >2,000 ng/ml at screening 4. use of anti-pulmonary fibrosis drugs in the past 14 days, (e.g., imatinib, nintedanib, pirfenidone, penicillamine, colchicine, tumor necrosis factor alpha blocker) 5. use of anti-cytokine release syndrome drugs in the past 5 days (anakinra, sarilumab, siltuximab, tocilizumab and/or lenzilumab) 6. use of biologics (omalizumab, mepolizumab, reslizumab, benralizumab and dupilumab) to treat asthma in the past 14 days 7. use of systemic corticosteroids (e.g., prednisone) in the past 5 days 8. an active infection or infection with a fever ≥ 38.5°c within 3 days of the first scheduled day of dosing 9. poorly controlled intercurrent illnesses, such as interstitial lung disease, uncontrolled hypertension; poorly controlled diabetes mellitus; unstable angina, myocardial infarction, acute coronary syndrome or cerebrovascular event within 6 months of screening; history of congestive heart failure (nyha class iii or iv); severe valvular heart disease; or poorly controlled cardiac arrhythmias not responding to medical therapy or a pacemaker 10. qtc with fridericia's correction that is unmeasurable, or ≥480 msec on screening ecg. the average corrected qt interval (qtc) from the screening ecg (completed in triplicate) must be <480 msec for the patient to be eligible for the study 11. participants taking any concomitant medication that may cause qtc prolongation, induce torsades de pointes are not eligible if qtc ≥460 msec 12. patients who have undergone thoracotomy within 4 weeks of day 1 of protocol therapy 13. patients that have a known allergy to any of the placebo components 14. psychiatric conditions, social situations or substance abuse that precludes the ability of the study participant to cooperate with the requirements of the trial and protocol therapy 15. pregnancy 16. women who are breastfeeding 17. past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.