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

1. inability to provide informed consent or to return to the investigator's site for scheduled infusions and evaluations. 2. exhibiting signs of moderate or severe pulmonary disease (such as copd, asthma, or pulmonary fibrosis). 3. ongoing requirement of oxygen therapy. 4. pulse oxygen saturation (spo2) of \<94% on room air at the time of screening. 5. thrombocytopenia (platelets \<100×109/l), anemia (hemoglobin \<9.0 g/dl), or leukopenia (wbc \<3×109/l) on screening labs 6. history of splenectomy. 7. known hypercoagulable state or at increased risk of thrombosis (e.g., due to immobility) 8. liver cirrhosis or patient showing signs of clinical jaundice at the time of screening. 9. transaminase (alt or ast) \>3x uln or total bilirubin \>2x uln at screening 10. chronic kidney disease stage 4 or requiring dialysis at the time of screening. 11. estimated gfr \<60 ml/min/1.73 m2 at the time of screening 12. nyha class iii or iv congestive heart failure (chf). 13. exhibiting signs of uncontrolled hypo-or hyper-thyroidism at the time of screening. 14. diagnosis of autoimmune disease (e.g., sle, rheumatoid arthritis, psoriasis) at the time of screening 15. uncontrolled rheumatologic disorders at the time of screening. 16. diagnosis of sleep apnea (central or obstructive) at the time of screening. 17. history of organ transplantation or are candidates for organ transplantation at the time of screening. 18. history of chronic fatigue syndrome prior to covid-19 infection. 19. history of fibromyalgia prior to covid-19 infection. 20. history of major psychiatric disorder including psychotic or melancholic features, bipolar disorders, schizophrenia of any subtype, schizoaffective disorder, major depression delusional disorders of any subtype, dementias of any subtype, anorexia nervosa or bulimia nervosa. 21. any malignancy within the past 5 years, excluding successfully treated basal cell carcinoma or squamous cell carcinoma without evidence of metastases. 22. any other clinically significant serious systemic diseases, chronic or intercurrent active medical disorder and other reasons which would interfere with study conduct or study results interpretation per the investigator. 23. chronic or intercurrent acute medical disorder or disease making implementation or interpretation of the protocol or results difficult or unsafe per the investigator. 24. therapy with interferons, interleukins, or other cytokines or investigational drugs within 6 weeks of beginning study medication. subjects must give written informed consent prior to discontinuation of investigational drugs. 25. treatment with any of the following therapies within the eight (8) weeks immediately preceding the start of study baseline or during baseline: systemic glucocorticoids (i.e., hydrocortisone, prednisone, etc.) or mineralocorticoids (i.e., fludrocortisone (florinef), etc.), interferons, interleukin-2, systemic antivirals, gamma globulin or investigational drugs or experimental agents not yet approved for use in the united states. 26. prior participation in an ampligen® study. 27. medical necessity, as determined by the patient's primary doctor or the principal investigator, to continue aspirin (asa) or non-steroidal anti-inflammatory (nsaid) drugs for 20 consecutive days or for more than 10% of the study duration. 28. history of congestive heart failure, suspected or known dissecting aneurysm, recent systemic or pulmonary embolus or myocardial infarction (≤ 6 months), severe valvular heart disease, ventricular aneurysm, active or suspected myocarditis or pericarditis, thrombophlebitis or intracardiac thrombi, or acute infection. 29. evidence of moderate or severe obstructive pulmonary disease. 30. resting diastolic blood pressure \> 115 mm hg or resting systolic blood pressure \> 200 mm hg. 31. uncontrolled metabolic disease (e.g., diabetes, thyrotoxicosis, or myxedema). 32. concurrent use of any beta blockers and/or bronchodilators which cannot remain at a stable dosage level during baseline and the study. 33. history of alcohol or other substance abuse within two (2) years before the onset of acute covid-19 or at any time afterward. 34. history of suicidal ideation, suicide attempt, or suicidal behavior within two (2) years of baseline. a score of 10 or greater on the phq-9 at baseline indicates symptoms of depression and will exclude subject. a score of greater than zero on question nine (9) of the phq-9 at baseline indicates suicidal ideation and will exclude subject. 35. pregnant or breast feeding. 36. participation in another study for an investigational treatment.

1. inability to provide informed consent or to return to the investigator's site for scheduled infusions and evaluations. 2. exhibiting signs of moderate or severe pulmonary disease (such as copd, asthma, or pulmonary fibrosis). 3. ongoing requirement of oxygen therapy. 4. pulse oxygen saturation (spo2) of \<94% on room air at the time of screening. 5. thrombocytopenia (platelets \<100×109/l), anemia (hemoglobin \<9.0 g/dl), or leukopenia (wbc \<3×109/l) on screening labs 6. history of splenectomy. 7. known hypercoagulable state or at increased risk of thrombosis (e.g., due to immobility) 8. liver cirrhosis or patient showing signs of clinical jaundice at the time of screening. 9. transaminase (alt or ast) \>3x uln or total bilirubin \>2x uln at screening 10. chronic kidney disease stage 4 or requiring dialysis at the time of screening. 11. estimated gfr \<60 ml/min/1.73 m2 at the time of screening 12. nyha class iii or iv congestive heart failure (chf). 13. exhibiting signs of uncontrolled hypo-or hyper-thyroidism at the time of screening. 14. diagnosis of autoimmune disease (e.g., sle, rheumatoid arthritis, psoriasis) at the time of screening 15. uncontrolled rheumatologic disorders at the time of screening. 16. diagnosis of sleep apnea (central or obstructive) at the time of screening. 17. history of organ transplantation or are candidates for organ transplantation at the time of screening. 18. history of chronic fatigue syndrome prior to covid-19 infection. 19. history of fibromyalgia prior to covid-19 infection. 20. history of major psychiatric disorder including psychotic or melancholic features, bipolar disorders, schizophrenia of any subtype, schizoaffective disorder, major depression delusional disorders of any subtype, dementias of any subtype, anorexia nervosa or bulimia nervosa. 21. any malignancy within the past 5 years, excluding successfully treated basal cell carcinoma or squamous cell carcinoma without evidence of metastases. 22. any other clinically significant serious systemic diseases, chronic or intercurrent active medical disorder and other reasons which would interfere with study conduct or study results interpretation per the investigator. 23. chronic or intercurrent acute medical disorder or disease making implementation or interpretation of the protocol or results difficult or unsafe per the investigator. 24. therapy with interferons, interleukins, or other cytokines or investigational drugs within 6 weeks of beginning study medication. subjects must give written informed consent prior to discontinuation of investigational drugs. 25. treatment with any of the following therapies within the eight (8) weeks immediately preceding the start of study baseline or during baseline: systemic glucocorticoids (i.e., hydrocortisone, prednisone, etc.) or mineralocorticoids (i.e., fludrocortisone (florinef), etc.), interferons, interleukin-2, systemic antivirals, gamma globulin or investigational drugs or experimental agents not yet approved for use in the united states. 26. prior participation in an ampligen® study. 27. medical necessity, as determined by the patient's primary doctor or the principal investigator, to continue aspirin (asa) or non-steroidal anti-inflammatory (nsaid) drugs for 20 consecutive days or for more than 10% of the study duration. 28. history of congestive heart failure, suspected or known dissecting aneurysm, recent systemic or pulmonary embolus or myocardial infarction (≤ 6 months), severe valvular heart disease, ventricular aneurysm, active or suspected myocarditis or pericarditis, thrombophlebitis or intracardiac thrombi, or acute infection. 29. evidence of moderate or severe obstructive pulmonary disease. 30. resting diastolic blood pressure \> 115 mm hg or resting systolic blood pressure \> 200 mm hg. 31. uncontrolled metabolic disease (e.g., diabetes, thyrotoxicosis, or myxedema). 32. concurrent use of any beta blockers and/or bronchodilators which cannot remain at a stable dosage level during baseline and the study. 33. history of alcohol or other substance abuse within two (2) years before the onset of acute covid-19 or at any time afterward. 34. history of suicidal ideation, suicide attempt, or suicidal behavior within two (2) years of baseline. a score of 10 or greater on the phq-9 at baseline indicates symptoms of depression and will exclude subject. a score of greater than zero on question nine (9) of the phq-9 at baseline indicates suicidal ideation and will exclude subject. 35. pregnant or breast feeding. 36. participation in another study for an investigational treatment.

Oct. 26, 2022, 8 a.m. usa

inability to provide informed consent or to return to the investigator's site for scheduled infusions and evaluations. exhibiting signs of moderate or severe pulmonary disease (such as copd, asthma, or pulmonary fibrosis). ongoing requirement of oxygen therapy. pulse oxygen saturation (spo2) of <94% on room air at the time of screening. thrombocytopenia (platelets <100×109/l), anemia (hemoglobin <9.0 g/dl), or leukopenia (wbc <3×109/l) on screening labs history of splenectomy. known hypercoagulable state or at increased risk of thrombosis (e.g., due to immobility) liver cirrhosis or patient showing signs of clinical jaundice at the time of screening. transaminase (alt or ast) >3x uln or total bilirubin >2x uln at screening chronic kidney disease stage 4 or requiring dialysis at the time of screening. estimated gfr <60 ml/min/1.73 m2 at the time of screening nyha class iii or iv congestive heart failure (chf). exhibiting signs of uncontrolled hypo-or hyper-thyroidism at the time of screening. diagnosis of autoimmune disease (e.g., sle, rheumatoid arthritis, psoriasis) at the time of screening uncontrolled rheumatologic disorders at the time of screening. diagnosis of sleep apnea (central or obstructive) at the time of screening. history of organ transplantation or are candidates for organ transplantation at the time of screening. history of chronic fatigue syndrome prior to covid-19 infection. history of fibromyalgia prior to covid-19 infection. history of major psychiatric disorder including psychotic or melancholic features, bipolar disorders, schizophrenia of any subtype, schizoaffective disorder, major depression delusional disorders of any subtype, dementias of any subtype, anorexia nervosa or bulimia nervosa. any malignancy within the past 5 years, excluding successfully treated basal cell carcinoma or squamous cell carcinoma without evidence of metastases. any other clinically significant serious systemic diseases, chronic or intercurrent active medical disorder and other reasons which would interfere with study conduct or study results interpretation per the investigator. chronic or intercurrent acute medical disorder or disease making implementation or interpretation of the protocol or results difficult or unsafe per the investigator. therapy with interferons, interleukins, or other cytokines or investigational drugs within 6 weeks of beginning study medication. subjects must give written informed consent prior to discontinuation of investigational drugs. treatment with any of the following therapies within the eight (8) weeks immediately preceding the start of study baseline or during baseline: systemic glucocorticoids (i.e., hydrocortisone, prednisone, etc.) or mineralocorticoids (i.e., fludrocortisone (florinef), etc.), interferons, interleukin-2, systemic antivirals, gamma globulin or investigational drugs or experimental agents not yet approved for use in the united states. prior participation in an ampligen® study. medical necessity, as determined by the patient's primary doctor or the principal investigator, to continue aspirin (asa) or non-steroidal anti-inflammatory (nsaid) drugs for 20 consecutive days or for more than 10% of the study duration. history of congestive heart failure, suspected or known dissecting aneurysm, recent systemic or pulmonary embolus or myocardial infarction (≤ 6 months), severe valvular heart disease, ventricular aneurysm, active or suspected myocarditis or pericarditis, thrombophlebitis or intracardiac thrombi, or acute infection. evidence of moderate or severe obstructive pulmonary disease. resting diastolic blood pressure > 115 mm hg or resting systolic blood pressure > 200 mm hg. uncontrolled metabolic disease (e.g., diabetes, thyrotoxicosis, or myxedema). concurrent use of any beta blockers and/or bronchodilators which cannot remain at a stable dosage level during baseline and the study. history of alcohol or other substance abuse within two (2) years before the onset of acute covid-19 or at any time afterward. history of suicidal ideation, suicide attempt, or suicidal behavior within two (2) years of baseline. a score of 10 or greater on the phq-9 at baseline indicates symptoms of depression and will exclude subject. a score of greater than zero on question nine (9) of the phq-9 at baseline indicates suicidal ideation and will exclude subject. pregnant or breast feeding. participation in another study for an investigational treatment.

inability to provide informed consent or to return to the investigator's site for scheduled infusions and evaluations. exhibiting signs of moderate or severe pulmonary disease (such as copd, asthma, or pulmonary fibrosis). ongoing requirement of oxygen therapy. pulse oxygen saturation (spo2) of <94% on room air at the time of screening. thrombocytopenia (platelets <100×109/l), anemia (hemoglobin <9.0 g/dl), or leukopenia (wbc <3×109/l) on screening labs history of splenectomy. known hypercoagulable state or at increased risk of thrombosis (e.g., due to immobility) liver cirrhosis or patient showing signs of clinical jaundice at the time of screening. transaminase (alt or ast) >3x uln or total bilirubin >2x uln at screening chronic kidney disease stage 4 or requiring dialysis at the time of screening. estimated gfr <60 ml/min/1.73 m2 at the time of screening nyha class iii or iv congestive heart failure (chf). exhibiting signs of uncontrolled hypo-or hyper-thyroidism at the time of screening. diagnosis of autoimmune disease (e.g., sle, rheumatoid arthritis, psoriasis) at the time of screening uncontrolled rheumatologic disorders at the time of screening. diagnosis of sleep apnea (central or obstructive) at the time of screening. history of organ transplantation or are candidates for organ transplantation at the time of screening. history of chronic fatigue syndrome prior to covid-19 infection. history of fibromyalgia prior to covid-19 infection. history of major psychiatric disorder including psychotic or melancholic features, bipolar disorders, schizophrenia of any subtype, schizoaffective disorder, major depression delusional disorders of any subtype, dementias of any subtype, anorexia nervosa or bulimia nervosa. any malignancy within the past 5 years, excluding successfully treated basal cell carcinoma or squamous cell carcinoma without evidence of metastases. any other clinically significant serious systemic diseases, chronic or intercurrent active medical disorder and other reasons which would interfere with study conduct or study results interpretation per the investigator. chronic or intercurrent acute medical disorder or disease making implementation or interpretation of the protocol or results difficult or unsafe per the investigator. therapy with interferons, interleukins, or other cytokines or investigational drugs within 6 weeks of beginning study medication. subjects must give written informed consent prior to discontinuation of investigational drugs. treatment with any of the following therapies within the eight (8) weeks immediately preceding the start of study baseline or during baseline: systemic glucocorticoids (i.e., hydrocortisone, prednisone, etc.) or mineralocorticoids (i.e., fludrocortisone (florinef), etc.), interferons, interleukin-2, systemic antivirals, gamma globulin or investigational drugs or experimental agents not yet approved for use in the united states. prior participation in an ampligen® study. medical necessity, as determined by the patient's primary doctor or the principal investigator, to continue aspirin (asa) or non-steroidal anti-inflammatory (nsaid) drugs for 20 consecutive days or for more than 10% of the study duration. history of congestive heart failure, suspected or known dissecting aneurysm, recent systemic or pulmonary embolus or myocardial infarction (≤ 6 months), severe valvular heart disease, ventricular aneurysm, active or suspected myocarditis or pericarditis, thrombophlebitis or intracardiac thrombi, or acute infection. evidence of moderate or severe obstructive pulmonary disease. resting diastolic blood pressure > 115 mm hg or resting systolic blood pressure > 200 mm hg. uncontrolled metabolic disease (e.g., diabetes, thyrotoxicosis, or myxedema). concurrent use of any beta blockers and/or bronchodilators which cannot remain at a stable dosage level during baseline and the study. history of alcohol or other substance abuse within two (2) years before the onset of acute covid-19 or at any time afterward. history of suicidal ideation, suicide attempt, or suicidal behavior within two (2) years of baseline. a score of 10 or greater on the phq-9 at baseline indicates symptoms of depression and will exclude subject. a score of greater than zero on question nine (9) of the phq-9 at baseline indicates suicidal ideation and will exclude subject. pregnant or breast feeding. participation in another study for an investigational treatment.