Last updated: February 9, 2022
Sponsor: Heinrich-Heine University, Duesseldorf
Overall Status: Completed
Phase
2
Condition
Corona Virus
Covid-19
Treatment
N/AClinical Study ID
NCT04681430
RES-Q-HR
2020-004695-18
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Individuals (female, male, diverse) ≥ 18 years with SARS-CoV-2 infection, confirmed byPCR 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, sorethroat, 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, coronaryartery 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 withGFR <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 pulmonaryfibrosis
Exclusion
Exclusion Criteria:
- 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 forother reasons than COVID-19 may be included if they fulfill all inclusion and none ofthe 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 ofnormal (ULN) at screening
- Liver cirrhosis > Child A (patients with Child B/C cirrhosis are excluded from thetrial)
- 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 ScreeningVisit
Study Design
Total Participants: 22
Study Start date:
January 08, 2021
Estimated Completion Date:
October 29, 2021
Study Description
Connect with a study center
Abteilung Infektiologie Klinik für Innere Medizin II Department Innere Medizin Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Württemberg 79106
GermanySite Not Available
Klinik und Poliklinik für Innere Medizin II Klinikum rechts der Isar Technische Universität München
München, Bavaria 81675
GermanySite Not Available
Universitätsklinikum Frankfurt Medizinische Klinik 2: Hämatologie, Onkologie, Hämostaseologie, Rheumatologie, Infektiologie/HIV
Frankfurt am Main, Hessen 60590
GermanySite Not Available
Universitätsklinikum Düsseldorf Klinik für Hepatologie und Infektiologie
Duesseldorf, North Rhine Westphalia 40225
GermanySite Not Available
Klinikum Dortmund
Dortmund, North Rhine-Westphalia 44137
GermanySite Not Available
Universitätsklinikum Essen
Essen, North Rhine-Westphalia 45147
GermanySite Not Available

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