Reconvalescent Plasma/Camostat Mesylate Early in SARS-CoV-2 Q-PCR (COVID-19) Positive High-risk Individuals
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Corona Virus Infection
- SARS-CoV-2 Acute Respiratory Disease
- SARS CoV-2 Infection
- SARS-CoV-2 PCR Test Positive
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The study is a multicenter trial that will be conducted in approx. 10 - 15 centers in Germany. At each center, patients will be randomized into four groups: two treatment groups and two control groups. The randomization rate in this study is two to one (2:1) in favor to therapy, i.e. included patients have twice the chance to receive interventional therapy than placebo / SoC.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: The camostat mesylate and its placebo group will be double blinded while the CP and its placebo will be open label.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT04681430
- Collaborators
- The Federal Ministry of Health, Germany (Bundesministerium für Gesundheit, BMG)
- Investigators
- Principal Investigator: Verena Keitel-Anselmino, Prof.Dr.med. Klinik für Gastroenterologie, Hepatologie und Infektiologie Universitätsklinikum Düsseldorf
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