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Feb. 25, 2022, noon oms

Exclusion Criteria-Part A: <br/ > 1. Patients who cannot follow-up with study participation requirements <br/ > 2. Investigator considers patient is inappropriate to enroll in the trial <br/ > 3. Pre-existing chronic respiratory condition(s), obstructive or restrictive, for which the patient is actively taking concomitant medication are excluded. Patients with history of Idiopathic Pulmonary Fibrosis (IPF), lung cancer, pulmonary arterial hypertension, other interstitial lung diseases, severe cardiac insufficiency (grade IV) are excluded irrespective of whether they are actively being medicated for those conditions or not. <br/ > 4. Pre-existing co-morbid conditions preventing outcome assessments, e.g., neurological, medical, orthopedic injury/disability, disease or condition that would prevent ability to transfer and walk for 6 minutes, prior to confirmed COVID-19 diagnosis <br/ > 5. Co-morbid diagnosis of tuberculosis <br/ > 6. Unstable angina or myocardial infarction in the last month prior to screening <br/ > 7. Pre-existing co-morbidity associated with life expectancy less than 1 year <br/ > 8. Present life expectancy less than 3 days and/or LDH > 360 <br/ > 9. Body mass index â?¥ 45kg/m2 <br/ > 10. Resting heart rate of â?¥ 120 bpm, systolic blood pressure of > 180 mm Hg and a diastolic blood pressure of > 100 mm Hg and/or or a fall in pulse oximetry oxygen saturation (SpO2) to <80% upon ambulation <br/ > 11. Sepsis, septic/hypovolemic/cardiogenic/neurogenic shock <br/ > 12. Patients on MV, ECMO, NIV, HFNO or other high flow oxygen (FiO2 â?¥35% and flow rate â?¥ 8 lpm) within the last 72 hours prior to screening <br/ > 13. History of anaphylactic reaction (particularly reactions to general anesthetic agents), allergic reaction due to any drug which led to significant morbidity, prior allergic reaction to pirfenidone. <br/ > 14. Known symptoms of dysphagia or known difficulty in swallowing capsules and/or total gastrectomy <br/ > 15. Patients undergoing dialysis or hemoperfusion, or with a history of dialysis or hemoperfusion, or anticipated to require dialysis or hemoperfusion within 72 hours of screening or severe renal impairment (defined as creatinine clearance rate <30 mL/min) at the time of screening/baseline. <br/ > 16. Use of any of the following drugs: <br/ > a. Fluvoxamine, enoxacin, ciprofloxacin <br/ > b. Treatment with steroids under institutional protocols and guidelines to manage COVID-19 pneumonia/respiratory symptoms is allowed. Use of steroids off-label to treat non-COVID-19 related conditions is not allowed. <br/ > c. Any Investigational Agents (i.e., non-approved or nonauthorized drugs), with the exception of those used for COVID-19 respiratory diseases that the investigator deems clinically relevant in combination with the study drug, as described below: <br/ > i. Allowed agents <br/ > â?¢ Patients who had received prior investigational agents for COVID-19 but are no longer taking those drugs are allowed. <br/ > â?¢ Inhaled corticosteroids are allowed. <br/ > â?¢ Patients that received prior convalescent plasma are allowed, however, concomitant convalescent plasma is excluded. <br/ > ii. Excluded agents <br/ > â?¢ Patients on concomitant experimental anti-viral, anti-fibrotic or anti-inflammatory therapies are excluded. <br/ > â?¢ Any investigational agent not explicitly on this list should be reviewed by the medical monitor prior to initiating therapy or enrolling participant. <b

Exclusion Criteria-Part A: <br/ > 1. Patients who cannot follow-up with study participation requirements <br/ > 2. Investigator considers patient is inappropriate to enroll in the trial <br/ > 3. Pre-existing chronic respiratory condition(s), obstructive or restrictive, for which the patient is actively taking concomitant medication are excluded. Patients with history of Idiopathic Pulmonary Fibrosis (IPF), lung cancer, pulmonary arterial hypertension, other interstitial lung diseases, severe cardiac insufficiency (grade IV) are excluded irrespective of whether they are actively being medicated for those conditions or not. <br/ > 4. Pre-existing co-morbid conditions preventing outcome assessments, e.g., neurological, medical, orthopedic injury/disability, disease or condition that would prevent ability to transfer and walk for 6 minutes, prior to confirmed COVID-19 diagnosis <br/ > 5. Co-morbid diagnosis of tuberculosis <br/ > 6. Unstable angina or myocardial infarction in the last month prior to screening <br/ > 7. Pre-existing co-morbidity associated with life expectancy less than 1 year <br/ > 8. Present life expectancy less than 3 days and/or LDH > 360 <br/ > 9. Body mass index â?¥ 45kg/m2 <br/ > 10. Resting heart rate of â?¥ 120 bpm, systolic blood pressure of > 180 mm Hg and a diastolic blood pressure of > 100 mm Hg and/or or a fall in pulse oximetry oxygen saturation (SpO2) to <80% upon ambulation <br/ > 11. Sepsis, septic/hypovolemic/cardiogenic/neurogenic shock <br/ > 12. Patients on MV, ECMO, NIV, HFNO or other high flow oxygen (FiO2 â?¥35% and flow rate â?¥ 8 lpm) within the last 72 hours prior to screening <br/ > 13. History of anaphylactic reaction (particularly reactions to general anesthetic agents), allergic reaction due to any drug which led to significant morbidity, prior allergic reaction to pirfenidone. <br/ > 14. Known symptoms of dysphagia or known difficulty in swallowing capsules and/or total gastrectomy <br/ > 15. Patients undergoing dialysis or hemoperfusion, or with a history of dialysis or hemoperfusion, or anticipated to require dialysis or hemoperfusion within 72 hours of screening or severe renal impairment (defined as creatinine clearance rate <30 mL/min) at the time of screening/baseline. <br/ > 16. Use of any of the following drugs: <br/ > a. Fluvoxamine, enoxacin, ciprofloxacin <br/ > b. Treatment with steroids under institutional protocols and guidelines to manage COVID-19 pneumonia/respiratory symptoms is allowed. Use of steroids off-label to treat non-COVID-19 related conditions is not allowed. <br/ > c. Any Investigational Agents (i.e., non-approved or nonauthorized drugs), with the exception of those used for COVID-19 respiratory diseases that the investigator deems clinically relevant in combination with the study drug, as described below: <br/ > i. Allowed agents <br/ > â?¢ Patients who had received prior investigational agents for COVID-19 but are no longer taking those drugs are allowed. <br/ > â?¢ Inhaled corticosteroids are allowed. <br/ > â?¢ Patients that received prior convalescent plasma are allowed, however, concomitant convalescent plasma is excluded. <br/ > ii. Excluded agents <br/ > â?¢ Patients on concomitant experimental anti-viral, anti-fibrotic or anti-inflammatory therapies are excluded. <br/ > â?¢ Any investigational agent not explicitly on this list should be reviewed by the medical monitor prior to initiating therapy or enrolling participant. <b