Reconvalescent Plasma/Camostat Mesylate Early in SARS-CoV-2 Q-PCR (COVID-19) Positive High-risk Individuals

Last updated: February 9, 2022
Sponsor: Heinrich-Heine University, Duesseldorf
Overall Status: Completed

Phase

2

Condition

Corona Virus

Covid-19

Treatment

N/A

Clinical Study ID

NCT04681430
RES-Q-HR
2020-004695-18
  • Ages > 18
  • All Genders

Study 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 adult patients diagnosed with SARS-CoV-2 and high risk for moderate/severe COVID-19. The working hypothesis to be tested in the RES-Q-HR study is that the early use of convalescent plasma (CP) or camostat mesylate (Foipan®) reduces the likelihood of disease progression to modified WHO stages 4b-8 in SARS-CoV-2 positive adult patients at high risk of moderate or severe COVID-19 progression. The primary endpoint of the study is the cumulative number of individuals who progressed to or beyond category 4b on the modified WHO (World Health Organization) COVID-19 ordinal scale within 28 days after randomization.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Individuals (female, male, diverse) ≥ 18 years with SARS-CoV-2 infection, confirmed byPCR 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, sorethroat, headache, fatigue, smell/and or taste disorder, diarrhea, abdominal symptoms,exanthema) and symptom duration <= 3 days.
  4. Ability to provide written 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, 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:

  1. Age <18 years
  2. Unable to give informed consent
  3. Pregnant women or breast-feeding mothers
  4. Previous transfusion reaction or other contraindication to a plasma transfusion
  5. Known hypersensitivity to camostat mesylate and/or severe pancreatitis
  6. Volume stress due to CP administration would be intolerable
  7. Known IgA deficiency
  8. Life expectancy < 6 months
  9. Duration SARS-CoV-2 typical symptoms > 3 days
  10. SARS-CoV-2 PCR detection older than 3 days
  11. 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).
  12. Previously or currently hospitalized due to SARS-CoV-2
  13. Previous antiviral therapy for SARS-CoV-2
  14. alanine aminotransferase (ALT) or aspartate transferase (AST) > 5 times upper limit ofnormal (ULN) at screening
  15. Liver cirrhosis > Child A (patients with Child B/C cirrhosis are excluded from thetrial)
  16. Chronic kidney disease with GFR < 30 ml/min
  17. Concurrent or planned anticancer treatment during trial period
  18. Accommodation in an institution due to legal orders (§40(4) AMG).
  19. Any psycho-social condition hampering compliance with the study protocol.
  20. Evidence of current drug or alcohol abuse.
  21. Use of other investigational treatment within 5 half-lives of enrollment is prohibited
  22. Previous use of convalescent plasma for COVID-19
  23. Concomitant proven influenza A infection
  24. 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

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 trial focusses on SARS-CoV-2 positive patients with pre-existing risk factors for a moderate or severe COVID-19 disease course. 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 adult patients diagnosed with SARS-CoV-2 and high risk for moderate/severe COVID-19. Camostat mesylate acts as an inhibitor of the host cell serine protease TMPRSS2 and prevents the virus from entering the cell. Convalescent plasma (CP) represents another antiviral strategy in terms of passive immunization. The working hypothesis to be tested in the RES-Q HR study is that the early use of convalescent plasma (CP) or camostat mesylate (Foipan®) reduces the likelihood of disease progression to modified WHO stages 4b-8 in SARS-CoV-2 positive adult patients at high risk of moderate or severe COVID-19 progression.

Connect with a study center

  • Abteilung Infektiologie Klinik für Innere Medizin II Department Innere Medizin Universitätsklinikum Freiburg

    Freiburg im Breisgau, Baden-Württemberg 79106
    Germany

    Site Not Available

  • Klinik und Poliklinik für Innere Medizin II Klinikum rechts der Isar Technische Universität München

    München, Bavaria 81675
    Germany

    Site Not Available

  • Universitätsklinikum Frankfurt Medizinische Klinik 2: Hämatologie, Onkologie, Hämostaseologie, Rheumatologie, Infektiologie/HIV

    Frankfurt am Main, Hessen 60590
    Germany

    Site Not Available

  • Universitätsklinikum Düsseldorf Klinik für Hepatologie und Infektiologie

    Duesseldorf, North Rhine Westphalia 40225
    Germany

    Site Not Available

  • Klinikum Dortmund

    Dortmund, North Rhine-Westphalia 44137
    Germany

    Site Not Available

  • Universitätsklinikum Essen

    Essen, North Rhine-Westphalia 45147
    Germany

    Site Not Available

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