Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pharming Technologies B.V.
Patients fulfilling all eligibility criteria will be randomized in a 2:1 ratio in an open-label controlled design to treatment with rhC1-INH in addition to SOC or SOC only starting on day 0. The first rhC1-INH treatment will be administered on the same day and continued for a total of 4 days.
Age
18–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age 18-85 years,
Admitted to the hospital because of confirmed positive SARS-CoV-2 (COVID-19 infection).
Evidence of pulmonary involvement on CT scan or X-Ray of the chest,
Symptom onset within the previous 10 days AND at least one additional risk factor for progression to mechanical ventilation: 1) arterial hypertension, 2) \>50 years, 3) obesity (BMI\>30.0 kg/m2), 4) history of cardiovascular disease, 5) chronic pulmonary disease, 7) chronic renal disease, 6) C-reactive protein of \>35mg/L, 7) oxygen saturation at rest in ambient air of \<94%
You may not be if
Contraindications to the class of drugs under study (C1 esterase inhibitor);
History or suspicion of allergy to rabbits;
Women who are of childbearing potential and not using methods of contraception during the entire study period;
Pregnant or breastfeeding females or has a positive serum β-human chorionic gonadotropin (hCG) pregnancy test at screening;
Chronic liver disease (any Child-Pugh score B or C);
Currently admitted to an ICU or expected admission within the next 24 hours; and
Currently receiving invasive or non-invasive ventilation
Clareo Health | Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19
