Created at Source Raw Value Validated value
March 6, 2021, 1:30 a.m. eu

1. Trial subjects are in 18-75 years of age. 2. Severe COVID-19 infected patient (criteria applicable as one of the following): - Respiratory rate >30 breaths/min or rapidly worsening respiratory gas exchange (PaO2 <80 Hgmm on room air) OR - Evidence of rales/crackles on physical examination and SpO2 93% on room air, OR - increasing need for O2 supplementation greater than >50% Venturi mask, including use of non-invasive mechanical ventilation (NIMV) or High Flow Nasal Cannula, OR - Acute Lung Injury physiology confirmed by PaO2/FiO2 ratio of 300 Hgmm, OR - CT scan of the chest: presence of bilateral pulmonary infiltrates or 50% progression within 48 hours OR - COVID-19 infection associated secondary hemophagocytic lymphohistiocytosis (sHLH)/ macrophage activation syndrome (MAS) - HS scores greater than 169 3. Confirmed SARS-CoV2 infection, by specific lab results at least one positive rt-PCR or IgA/IgM test (1x SARS-CoV-2 PCR positive or if SARS-CoV-2 PCR negative, within 48 hours must have the 2. test SARS-CoV-2 PCR positive) 4. Female subjects: with childbearing potential are under efficient contraception, or in post-menopause. 5. The trial subject has the willingness to comply with study procedures and to give voluntary written informed consent signed and dated prior to enrolment.

1. Trial subjects are in 18-75 years of age. 2. Severe COVID-19 infected patient (criteria applicable as one of the following): - Respiratory rate >30 breaths/min or rapidly worsening respiratory gas exchange (PaO2 <80 Hgmm on room air) OR - Evidence of rales/crackles on physical examination and SpO2 93% on room air, OR - increasing need for O2 supplementation greater than >50% Venturi mask, including use of non-invasive mechanical ventilation (NIMV) or High Flow Nasal Cannula, OR - Acute Lung Injury physiology confirmed by PaO2/FiO2 ratio of 300 Hgmm, OR - CT scan of the chest: presence of bilateral pulmonary infiltrates or 50% progression within 48 hours OR - COVID-19 infection associated secondary hemophagocytic lymphohistiocytosis (sHLH)/ macrophage activation syndrome (MAS) - HS scores greater than 169 3. Confirmed SARS-CoV2 infection, by specific lab results at least one positive rt-PCR or IgA/IgM test (1x SARS-CoV-2 PCR positive or if SARS-CoV-2 PCR negative, within 48 hours must have the 2. test SARS-CoV-2 PCR positive) 4. Female subjects: with childbearing potential are under efficient contraception, or in post-menopause. 5. The trial subject has the willingness to comply with study procedures and to give voluntary written informed consent signed and dated prior to enrolment.