Created at Source Raw Value Validated value
Nov. 26, 2021, 10:30 p.m. oms

1.Patient with ordinal scale of â?¥5 at the time of hospital admission and randomization. <br/ >2.Pregnant and / or lactating female patients. <br/ >3.A family history of congenital or hereditary immunodeficiency. <br/ >4.Any disease condition requiring ICU admission or which in the judgment of the Investigator would compromise the patientâ??s health. <br/ >5.History of dialysis, silicosis, solid organ transplantation such as renal or cardiac transplants, and disorders of the heart, or nervous system, or other metabolic inflammatory conditions, psychiatric, occupational problems that make it unlikely that the patients will comply with the protocol as determined by the investigator. <br/ >6.History of administration of any immunoglobulins, any immunotherapy (antineoplastic chemotherapy, radiation therapy, immunosuppressants to induce tolerance to transplants, and corticosteroids use) and/or any blood products within the 3 months preceding study dosing, or planned future administrations during the study period. <br/ >7.History of allergic reactions or anaphylaxis to Mycobacterium w or its component. <br/ >8.Patients with generalized septic skin conditions. <br/ >9.Presence of any severe systemic/autoimmune disorders as determined by medical history and/or physical examination at the time of screening, which in the judgment of the Investigator would compromise the patientâ??s health or is likely to result in nonconformance to the protocol or a patientâ??s ability to give written informed consent. <br/ >

1.Patient with ordinal scale of â?¥5 at the time of hospital admission and randomization. <br/ >2.Pregnant and / or lactating female patients. <br/ >3.A family history of congenital or hereditary immunodeficiency. <br/ >4.Any disease condition requiring ICU admission or which in the judgment of the Investigator would compromise the patientâ??s health. <br/ >5.History of dialysis, silicosis, solid organ transplantation such as renal or cardiac transplants, and disorders of the heart, or nervous system, or other metabolic inflammatory conditions, psychiatric, occupational problems that make it unlikely that the patients will comply with the protocol as determined by the investigator. <br/ >6.History of administration of any immunoglobulins, any immunotherapy (antineoplastic chemotherapy, radiation therapy, immunosuppressants to induce tolerance to transplants, and corticosteroids use) and/or any blood products within the 3 months preceding study dosing, or planned future administrations during the study period. <br/ >7.History of allergic reactions or anaphylaxis to Mycobacterium w or its component. <br/ >8.Patients with generalized septic skin conditions. <br/ >9.Presence of any severe systemic/autoimmune disorders as determined by medical history and/or physical examination at the time of screening, which in the judgment of the Investigator would compromise the patientâ??s health or is likely to result in nonconformance to the protocol or a patientâ??s ability to give written informed consent. <br/ >

Nov. 13, 2021, 5:33 p.m. oms

N/A

N/A

Nov. 6, 2020, 11:45 p.m. oms

1.Patient with ordinal scale of â?¥5 at the time of hospital admission and randomization. <br/ >2.Pregnant and / or lactating female patients. <br/ >3.A family history of congenital or hereditary immunodeficiency. <br/ >4.Any disease condition requiring ICU admission or which in the judgment of the Investigator would compromise the patientâ??s health. <br/ >5.History of dialysis, silicosis, solid organ transplantation such as renal or cardiac transplants, and disorders of the heart, or nervous system, or other metabolic inflammatory conditions, psychiatric, occupational problems that make it unlikely that the patients will comply with the protocol as determined by the investigator. <br/ >6.History of administration of any immunoglobulins, any immunotherapy (antineoplastic chemotherapy, radiation therapy, immunosuppressants to induce tolerance to transplants, and corticosteroids use) and/or any blood products within the 3 months preceding study dosing, or planned future administrations during the study period. <br/ >7.History of allergic reactions or anaphylaxis to Mycobacterium w or its component. <br/ >8.Patients with generalized septic skin conditions. <br/ >9.Presence of any severe systemic/autoimmune disorders as determined by medical history and/or physical examination at the time of screening, which in the judgment of the Investigator would compromise the patientâ??s health or is likely to result in nonconformance to the protocol or a patientâ??s ability to give written informed consent. <br/ >

1.Patient with ordinal scale of â?¥5 at the time of hospital admission and randomization. <br/ >2.Pregnant and / or lactating female patients. <br/ >3.A family history of congenital or hereditary immunodeficiency. <br/ >4.Any disease condition requiring ICU admission or which in the judgment of the Investigator would compromise the patientâ??s health. <br/ >5.History of dialysis, silicosis, solid organ transplantation such as renal or cardiac transplants, and disorders of the heart, or nervous system, or other metabolic inflammatory conditions, psychiatric, occupational problems that make it unlikely that the patients will comply with the protocol as determined by the investigator. <br/ >6.History of administration of any immunoglobulins, any immunotherapy (antineoplastic chemotherapy, radiation therapy, immunosuppressants to induce tolerance to transplants, and corticosteroids use) and/or any blood products within the 3 months preceding study dosing, or planned future administrations during the study period. <br/ >7.History of allergic reactions or anaphylaxis to Mycobacterium w or its component. <br/ >8.Patients with generalized septic skin conditions. <br/ >9.Presence of any severe systemic/autoimmune disorders as determined by medical history and/or physical examination at the time of screening, which in the judgment of the Investigator would compromise the patientâ??s health or is likely to result in nonconformance to the protocol or a patientâ??s ability to give written informed consent. <br/ >