Created at Source Raw Value Validated value
Oct. 26, 2020, 7:26 a.m. eu

Patients are eligible to be included in the study only if they meet all the following criteria: 1. Age ≥18 years 2. Confirmed laboratory diagnosis of SARS-CoV2 by standard approved RT-PCR assay (local labs) within 7 days of enrollment. 3. Currently hospitalized. 4. Informed consent. 5. Has symptoms of severe COVID-19 as demonstrated by: a. At least one of the following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath at rest or with exertion, confusion, or symptoms of severe lower respiratory symptoms including dyspnea at rest or respiratory distress. AND b. Clinical signs indicative of lower respiratory infection with COVID-19, with at least one of the following: SpO2 <92% on room air in last 12 hours or requires ≥4 LPM oxygen by nasal canula, non-rebreather/Ventimask (or similar device) or high flow nasal canula in order to maintain SpO2 ≥92%, PaO2/FiO2 <300 mm/hg. Patients with COPD or chronic lung disease must demonstrate evidence of increased oxygen needs above baseline. 6. Elevated CRP > 2 x ULN. 7. Concurrent anti-viral and/or anti-inflammatory agents (e.g., biologics) are permitted. If in the physician’s judgement, it is in the best interest of the patient to use anti-viral or anti-inflammatory treatments, these treatments are to be documented in the patient’s chart and entered in the electronic case report form. Note: Patients who may have received plasma convalescent therapy > 48 hours prior to enrollment with no clinical improvement and who still meet criteria for severe COVID-19 may enroll. On study plasma convalescent therapy is not permitted. Patients who receive plasma convalescent therapy within 48 hours may be permitted to enroll based on discussion with sponsor. 8. Female patients of childbearing potential must have a negative serum pregnancy test at Screening. Female patients of childbearing potential and fertile male patients must use highly effective methods of contraception throughout the study and for 3 months following the last dose of study treatment. Highly effective methods of contraception are listed in Section 8.3.1. of the protocol.

Patients are eligible to be included in the study only if they meet all the following criteria: 1. Age ≥18 years 2. Confirmed laboratory diagnosis of SARS-CoV2 by standard approved RT-PCR assay (local labs) within 7 days of enrollment. 3. Currently hospitalized. 4. Informed consent. 5. Has symptoms of severe COVID-19 as demonstrated by: a. At least one of the following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath at rest or with exertion, confusion, or symptoms of severe lower respiratory symptoms including dyspnea at rest or respiratory distress. AND b. Clinical signs indicative of lower respiratory infection with COVID-19, with at least one of the following: SpO2 <92% on room air in last 12 hours or requires ≥4 LPM oxygen by nasal canula, non-rebreather/Ventimask (or similar device) or high flow nasal canula in order to maintain SpO2 ≥92%, PaO2/FiO2 <300 mm/hg. Patients with COPD or chronic lung disease must demonstrate evidence of increased oxygen needs above baseline. 6. Elevated CRP > 2 x ULN. 7. Concurrent anti-viral and/or anti-inflammatory agents (e.g., biologics) are permitted. If in the physician’s judgement, it is in the best interest of the patient to use anti-viral or anti-inflammatory treatments, these treatments are to be documented in the patient’s chart and entered in the electronic case report form. Note: Patients who may have received plasma convalescent therapy > 48 hours prior to enrollment with no clinical improvement and who still meet criteria for severe COVID-19 may enroll. On study plasma convalescent therapy is not permitted. Patients who receive plasma convalescent therapy within 48 hours may be permitted to enroll based on discussion with sponsor. 8. Female patients of childbearing potential must have a negative serum pregnancy test at Screening. Female patients of childbearing potential and fertile male patients must use highly effective methods of contraception throughout the study and for 3 months following the last dose of study treatment. Highly effective methods of contraception are listed in Section 8.3.1. of the protocol.