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

participants will be excluded from the study if 1 or more of the following criteria are applicable at screening: 1. age \< 18 years; 2. require immediate intubation due to advanced respiratory failure - including continuous positive airway pressure (cpap) and bi-level positive airway pressure (bipap); 3. require immediate admission to an intensive care unit (icu) for any reason; 4. on therapy with approved tnf inhibitor (eg: infliximab, etanercept, adalimumab, certolizumab pegol, golimumab, thalidomide, etc) in the last 6 months; 5. being treated with dexamethasone (iv or po) at a dose of \>15mg per day or solumedrol or equivalent corticosteroid at a dose of \>75mg per day; 6. taking any medication known to be ccr5 receptor antagonist (eg: leronlimab, aplaviroc, vicriviroc or maraviroc) in the last 6 months; 7. taking any medication known to inhibit the cytokine pathway (eg: anakinra, tocilizumab, siltuximab, etc) in the last 6 months; 8. known to be pregnant; 9. has known hiv, hcv or hbv infection; 10. has known mycobacterium tuberculosis infection or evidence of infection on chest x-ray; 11. significant hepatic disease (alt/ast\> 4 times the uln); 12. on therapy for cancer in the last 6 months; 13. on therapy for organ transplant in the last 6 months or on a waiting list for organ transplant, including patients on renal replacement therapy for any reason; 14. known hypersensitivity to investigational product or its excipients; 15. participating in an investigational drug or device trial; 16. congestive heart failure (chf) or myocardial infarction (mi) diagnosed in the last 2 months.

participants will be excluded from the study if 1 or more of the following criteria are applicable at screening: 1. age \< 18 years; 2. require immediate intubation due to advanced respiratory failure - including continuous positive airway pressure (cpap) and bi-level positive airway pressure (bipap); 3. require immediate admission to an intensive care unit (icu) for any reason; 4. on therapy with approved tnf inhibitor (eg: infliximab, etanercept, adalimumab, certolizumab pegol, golimumab, thalidomide, etc) in the last 6 months; 5. being treated with dexamethasone (iv or po) at a dose of \>15mg per day or solumedrol or equivalent corticosteroid at a dose of \>75mg per day; 6. taking any medication known to be ccr5 receptor antagonist (eg: leronlimab, aplaviroc, vicriviroc or maraviroc) in the last 6 months; 7. taking any medication known to inhibit the cytokine pathway (eg: anakinra, tocilizumab, siltuximab, etc) in the last 6 months; 8. known to be pregnant; 9. has known hiv, hcv or hbv infection; 10. has known mycobacterium tuberculosis infection or evidence of infection on chest x-ray; 11. significant hepatic disease (alt/ast\> 4 times the uln); 12. on therapy for cancer in the last 6 months; 13. on therapy for organ transplant in the last 6 months or on a waiting list for organ transplant, including patients on renal replacement therapy for any reason; 14. known hypersensitivity to investigational product or its excipients; 15. participating in an investigational drug or device trial; 16. congestive heart failure (chf) or myocardial infarction (mi) diagnosed in the last 2 months.

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

participants will be excluded from the study if 1 or more of the following criteria are applicable at screening: age < 18 years; require immediate intubation due to advanced respiratory failure - including continuous positive airway pressure (cpap) and bi-level positive airway pressure (bipap); require immediate admission to an intensive care unit (icu) for any reason; on therapy with approved tnf inhibitor (eg: infliximab, etanercept, adalimumab, certolizumab pegol, golimumab, thalidomide, etc) in the last 6 months; being treated with dexamethasone (iv or po) at a dose of >15mg per day or solumedrol or equivalent corticosteroid at a dose of >75mg per day; taking any medication known to be ccr5 receptor antagonist (eg: leronlimab, aplaviroc, vicriviroc or maraviroc) in the last 6 months; taking any medication known to inhibit the cytokine pathway (eg: anakinra, tocilizumab, siltuximab, etc) in the last 6 months; known to be pregnant; has known hiv, hcv or hbv infection; has known mycobacterium tuberculosis infection or evidence of infection on chest x-ray; significant hepatic disease (alt/ast> 4 times the uln); on therapy for cancer in the last 6 months; on therapy for organ transplant in the last 6 months or on a waiting list for organ transplant, including patients on renal replacement therapy for any reason; known hypersensitivity to investigational product or its excipients; participating in an investigational drug or device trial; congestive heart failure (chf) or myocardial infarction (mi) diagnosed in the last 2 months.

participants will be excluded from the study if 1 or more of the following criteria are applicable at screening: age < 18 years; require immediate intubation due to advanced respiratory failure - including continuous positive airway pressure (cpap) and bi-level positive airway pressure (bipap); require immediate admission to an intensive care unit (icu) for any reason; on therapy with approved tnf inhibitor (eg: infliximab, etanercept, adalimumab, certolizumab pegol, golimumab, thalidomide, etc) in the last 6 months; being treated with dexamethasone (iv or po) at a dose of >15mg per day or solumedrol or equivalent corticosteroid at a dose of >75mg per day; taking any medication known to be ccr5 receptor antagonist (eg: leronlimab, aplaviroc, vicriviroc or maraviroc) in the last 6 months; taking any medication known to inhibit the cytokine pathway (eg: anakinra, tocilizumab, siltuximab, etc) in the last 6 months; known to be pregnant; has known hiv, hcv or hbv infection; has known mycobacterium tuberculosis infection or evidence of infection on chest x-ray; significant hepatic disease (alt/ast> 4 times the uln); on therapy for cancer in the last 6 months; on therapy for organ transplant in the last 6 months or on a waiting list for organ transplant, including patients on renal replacement therapy for any reason; known hypersensitivity to investigational product or its excipients; participating in an investigational drug or device trial; congestive heart failure (chf) or myocardial infarction (mi) diagnosed in the last 2 months.

Feb. 8, 2021, 12:31 a.m. usa

participants will be excluded from the study if 1 or more of the following criteria are applicable at screening: 1. age < 18 years; 2. require immediate intubation due to advanced respiratory failure - including continuous positive airway pressure (cpap) and bi-level positive airway pressure (bipap); 3. require immediate admission to an intensive care unit (icu) for any reason; 4. on therapy with approved tnf inhibitor (eg: infliximab, etanercept, adalimumab, certolizumab pegol, golimumab, thalidomide, etc) in the last 6 months; 5. being treated with dexamethasone (iv or po) at a dose of >15mg per day or solumedrol or equivalent corticosteroid at a dose of >75mg per day; 6. taking any medication known to be ccr5 receptor antagonist (eg: leronlimab, aplaviroc, vicriviroc or maraviroc) in the last 6 months; 7. taking any medication known to inhibit the cytokine pathway (eg: anakinra, tocilizumab, siltuximab, etc) in the last 6 months; 8. known to be pregnant; 9. has known hiv, hcv or hbv infection; 10. has known mycobacterium tuberculosis infection or evidence of infection on chest x-ray; 11. significant hepatic disease (alt/ast> 4 times the uln); 12. on therapy for cancer in the last 6 months; 13. on therapy for organ transplant in the last 6 months or on a waiting list for organ transplant, including patients on renal replacement therapy for any reason; 14. known hypersensitivity to investigational product or its excipients; 15. participating in an investigational drug or device trial; 16. congestive heart failure (chf) or myocardial infarction (mi) diagnosed in the last 2 months.

participants will be excluded from the study if 1 or more of the following criteria are applicable at screening: 1. age < 18 years; 2. require immediate intubation due to advanced respiratory failure - including continuous positive airway pressure (cpap) and bi-level positive airway pressure (bipap); 3. require immediate admission to an intensive care unit (icu) for any reason; 4. on therapy with approved tnf inhibitor (eg: infliximab, etanercept, adalimumab, certolizumab pegol, golimumab, thalidomide, etc) in the last 6 months; 5. being treated with dexamethasone (iv or po) at a dose of >15mg per day or solumedrol or equivalent corticosteroid at a dose of >75mg per day; 6. taking any medication known to be ccr5 receptor antagonist (eg: leronlimab, aplaviroc, vicriviroc or maraviroc) in the last 6 months; 7. taking any medication known to inhibit the cytokine pathway (eg: anakinra, tocilizumab, siltuximab, etc) in the last 6 months; 8. known to be pregnant; 9. has known hiv, hcv or hbv infection; 10. has known mycobacterium tuberculosis infection or evidence of infection on chest x-ray; 11. significant hepatic disease (alt/ast> 4 times the uln); 12. on therapy for cancer in the last 6 months; 13. on therapy for organ transplant in the last 6 months or on a waiting list for organ transplant, including patients on renal replacement therapy for any reason; 14. known hypersensitivity to investigational product or its excipients; 15. participating in an investigational drug or device trial; 16. congestive heart failure (chf) or myocardial infarction (mi) diagnosed in the last 2 months.

Oct. 27, 2020, 11:31 p.m. usa

1. age < 18 years; 2. require immediate intubation due to advanced respiratory failure - including continuous positive airway pressure (cpap) and bi-level positive airway pressure (bipap); 3. require immediate admission to an intensive care unit (icu) for any reason; 4. on therapy with approved tnf inhibitor (eg: infliximab, aducanumab, thalidomide, etc) in the last 6 months; 5. being treated with dexamethasone (iv or po) at a dose of >6mg per day or methyl prednisolone (iv) at a dose of >32mg per day; 6. taking any medication known to be ccr5 receptor antagonist (eg: leronlimab, aplaviroc, vicriviroc or maraviroc) in the last 6 months; 7. taking any medication known to inhibit the cytokine pathway (eg: anakinra, tocilizumab, siltuximab, etc) in the last 6 months; 8. known to be pregnant; 9. has known hiv, hcv or hbv infection; 10. has known mycobacterium tuberculosis infection or evidence of infection on chest x-ray; 11. significant hepatic disease (alt/ast> 4 times the uln); 12. on therapy for cancer in the last 6 months; 13. on therapy for organ transplant in the last 6 months or on a waiting list for organ transplant, including patients on renal replacement therapy for any reason; 14. known hypersensitivity to investigational product or its excipients; 15. participating in an investigational drug or device trial.

1. age < 18 years; 2. require immediate intubation due to advanced respiratory failure - including continuous positive airway pressure (cpap) and bi-level positive airway pressure (bipap); 3. require immediate admission to an intensive care unit (icu) for any reason; 4. on therapy with approved tnf inhibitor (eg: infliximab, aducanumab, thalidomide, etc) in the last 6 months; 5. being treated with dexamethasone (iv or po) at a dose of >6mg per day or methyl prednisolone (iv) at a dose of >32mg per day; 6. taking any medication known to be ccr5 receptor antagonist (eg: leronlimab, aplaviroc, vicriviroc or maraviroc) in the last 6 months; 7. taking any medication known to inhibit the cytokine pathway (eg: anakinra, tocilizumab, siltuximab, etc) in the last 6 months; 8. known to be pregnant; 9. has known hiv, hcv or hbv infection; 10. has known mycobacterium tuberculosis infection or evidence of infection on chest x-ray; 11. significant hepatic disease (alt/ast> 4 times the uln); 12. on therapy for cancer in the last 6 months; 13. on therapy for organ transplant in the last 6 months or on a waiting list for organ transplant, including patients on renal replacement therapy for any reason; 14. known hypersensitivity to investigational product or its excipients; 15. participating in an investigational drug or device trial.

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

1. age < 18 years; 2. require immediate intubation due to advanced respiratory failure - including cpap and bipap; 3. require immediate admission to an icu for any reason; 4. on current therapy with approved tnf inhibitor (eg: thalidomide); 5. being treated with corticosteroids dose of >10mg per day; 6. taking any medication known to be ccr5 receptor antagonist (eg: leronlimab, aplaviroc, vicriviroc or maraviroc); 7. taking any medication known to inhibit the cytokine pathway (eg: anakinra, tocilizumab, siltuximab, etc); 8. known to be pregnant; 9. has known hiv, hcv or hbv infection; 10. has known mycobacterium tuberculosis infection or evidence of infection on chest x-ray; 11. significant hepatic disease (alt/ast> 4 times the uln); 12. on current therapy for cancer; 13. known hypersensitivity to investigational product or its excipients; 14. participating in an investigational drug or device trial.

1. age < 18 years; 2. require immediate intubation due to advanced respiratory failure - including cpap and bipap; 3. require immediate admission to an icu for any reason; 4. on current therapy with approved tnf inhibitor (eg: thalidomide); 5. being treated with corticosteroids dose of >10mg per day; 6. taking any medication known to be ccr5 receptor antagonist (eg: leronlimab, aplaviroc, vicriviroc or maraviroc); 7. taking any medication known to inhibit the cytokine pathway (eg: anakinra, tocilizumab, siltuximab, etc); 8. known to be pregnant; 9. has known hiv, hcv or hbv infection; 10. has known mycobacterium tuberculosis infection or evidence of infection on chest x-ray; 11. significant hepatic disease (alt/ast> 4 times the uln); 12. on current therapy for cancer; 13. known hypersensitivity to investigational product or its excipients; 14. participating in an investigational drug or device trial.