COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-004695-18/DE

University Hospital Center Düsseldorf - Clinic for Gastroenterology, Hepato

verena.keitel@med.uni-duesseldorf.de

2020-10-15

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

1. Individuals ≥ 18 years with SARS-CoV-2 infection, confirmed by PCR before study enrollment 2. SARS-CoV-2 positive PCR ≤ 3 days old (date of NP swab) 3. Presence of ≥ 1 SARS-CoV-2 typical symptom (fever, cough, shortness of breath, sore throat, headache, fatigue, smell/and or taste disorder, diarrhea, abdominal symptoms, exanthema) and symptom duration ≤ 3 days. 4. Ability to provide written informed consent, or presence of appointed legal guardian or authorized representative who can be informed in the patient's interest and can provided informed consent 5. Presence of at least one of the following criteria: - Patients > 75 years - Patients > 65 years with at least one other risk factor (BMI >35 kg/m2, coronary artery disease, CKD with GFR <60 ml/min, diabetes mellitus, active tumor disease) - Patients with a BMI >35 kg/m2 with at least one other risk factor (CAD, CKD with GFR <60 ml/min, diabetes mellitus, active tumor disease) - Patients with a BMI >40 kg/m2 - Patients with chronic obstructive pulmonary disease (COPD) and/or pulmonary fibrosis - Patients with CKD and a GFR <30 ml/min - Patients with chronic liver disease defined as liver cirrhosis child B or C

1. Age <18 years 2. Pregnant women or breast-feeding mothers 3. Previous transfusion reaction or other contraindication to a plasma transfusion 4. Known hypersensitivity to camostat mesylate and/or severe pancreatitis 5. Volume stress due to CP administration would be intolerable 6. Known IgA deficiency 7. Life expectancy < 6 months 8. Duration SARS-CoV-2 typical symptoms > 3 days 9. SARS-CoV-2 PCR detection older than 3 days 10. SARS-CoV-2 associated clinical condition ≥ WHO stage 3 (patients hospitalized for other reasons than COVID-19 may be included if they fulfill all inclusion and none of the exclusion criteria) 11. Previously or currently hospitalized due to SARS-CoV-2 12. Previous antiviral therapy for SARS-CoV-2 13. ALT or AST > 5 x ULN at screening 14. Accommodation in an institution due to legal orders (§40(4) AMG). 15. Any psycho-social condition hampering compliance with the study protocol. 16. Evidence of current drug or alcohol abuse.

3

Heinrich-Heine-University Düsseldorf

18

100

Germany

Mild disease at enrollment

1: Mild disease at enrollment

994

The primary endpoint of the study is the number of individuals whose clinical status is on the COVID-19 modified WHO ordinal scale ≥ 4b up to and including day 28.

Declared number of arm (5.0) differs from found arms (3.0)

Phase 2

[{"arm_notes": "", "treatment_id": 322, "treatment_name": "Convalescent plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 245, "treatment_name": "Camostat mesilate", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]