Status:
COMPLETED
Reconvalescent Plasma/Camostat Mesylate Early in SARS-CoV-2 Q-PCR (COVID-19) Positive High-risk Individuals
Lead Sponsor:
Heinrich-Heine University, Duesseldorf
Collaborating Sponsors:
The Federal Ministry of Health, Germany (Bundesministerium für Gesundheit, BMG)
Conditions:
Corona Virus Infection
SARS-CoV-2 Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is a 4-arm, multicenter, randomized, partly double- blind, controlled trial to evaluate the safety and efficacy of convalescent serum (CP) or camostat mesylate with control or placebo in ad...
Detailed Description
The novel coronavirus designated SARS CoV-2, and the disease caused by this virus designated COVID-19. No treatment is available for early disease stages and non-hospitalized patients to date. This tr...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 29 2021
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04681430
Start Date
January 8 2021
End Date
October 29 2021
Last Update
February 10 2022
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Abteilung Infektiologie Klinik für Innere Medizin II Department Innere Medizin Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
2
Klinik und Poliklinik für Innere Medizin II Klinikum rechts der Isar Technische Universität München
München, Bavaria, Germany, 81675
3
Universitätsklinikum Frankfurt Medizinische Klinik 2: Hämatologie, Onkologie, Hämostaseologie, Rheumatologie, Infektiologie/HIV
Frankfurt am Main, Hesse, Germany, 60590
4
Klinikum Dortmund
Dortmund, North Rhine-Westphalia, Germany, 44137