COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04681430

Verena Keitel-Anselmino, Prof.Dr.med.

keitelan@uni-duesseldorf.de

2020-12-23

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: individuals (female, male, diverse) ≥ 18 years with sars-cov-2 infection, confirmed by pcr before study enrollment sars-cov-2 positive pcr ≤ 3 days old (date of np swab) 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. ability to provide written informed consent 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, chronic kidney disease (ckd) with glomerular filtration rate (gfr) <60 ml/min but >= 30 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 but >= 30 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

age <18 years unable to give informed consent pregnant women or breast-feeding mothers previous transfusion reaction or other contraindication to a plasma transfusion known hypersensitivity to camostat mesylate and/or severe pancreatitis volume stress due to cp administration would be intolerable known iga deficiency life expectancy < 6 months duration sars-cov-2 typical symptoms > 3 days sars-cov-2 pcr detection older than 3 days 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). previously or currently hospitalized due to sars-cov-2 previous antiviral therapy for sars-cov-2 alanine aminotransferase (alt) or aspartate transferase (ast) > 5 times upper limit of normal (uln) at screening liver cirrhosis > child a (patients with child b/c cirrhosis are excluded from the trial) chronic kidney disease with gfr < 30 ml/min concurrent or planned anticancer treatment during trial period accommodation in an institution due to legal orders (§40(4) amg). any psycho-social condition hampering compliance with the study protocol. evidence of current drug or alcohol abuse. use of other investigational treatment within 5 half-lives of enrollment is prohibited previous use of convalescent plasma for covid-19 concomitant proven influenza a infection patients with organ or bone marrow transplant in the three months prior to screening visit

4

Heinrich-Heine University, Duesseldorf

18

100

Germany

Mild disease at enrollment

1: Mild disease at enrollment

22

WHO ordinal Covid-19 scale up to day 28

None

Phase 2

[{"arm_notes": "", "treatment_id": 322, "treatment_name": "Convalescent plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"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"}]