Reconvalescent plasma/camostat mesylate in early SARS-CoV-2 Q-PCR positive high-risk individuals (RES-Q-HR): a structured summary of a study protocol for a randomized controlled trial

This study is a 4-arm (parallel group), multicenter, randomized (2:2:1:1 ratio), partly double-blind, controlled trial to evaluate the safety and efficacy of convalescent plasma (CP) or camostat mesylate with control or placebo in adult patients diagnosed with SARS-CoV-2 infection and high risk for progression to moderate/severe COVID-19. Superiority of the intervention arms will be tested.ParticipantsThe trial is conducted at 10 –15 tertiary care centers in Germany. Individuals aged 18 years or above with ability to provide written informed consent with SARS-CoV-2 infection, confirmed by PCR within 3 days or less before enrolment and the presence of at least one SARS-CoV-2 symptom (such as fever, cough, shortness of b reath, sore throat, headache, fatigue, smell/and or taste disorder, diarrhea, abdominal symptoms, exanthema) and symptom duration of not more than 3 days.Further inclusion criteria comprise:Presence of at least one of the following criteria indicating increased risk for severe COVID-19:Age>  75 yearsChronic obstructive pulmonary disease (COPD) and/or pulmonary fibrosisBMI>  40 kg/m2Age>  65 years with at least one other risk factor (BMI>  35 kg/m2, coronary artery disease (CAD), chronic kidney disease (CKD) with GFR<  60 ml/min but ≥ 30 ml/min, diabetes mellitus, active tumor disease)BMI>  35 kg/m2 with at least one other risk factor (CAD, CKD with GFR<  60 ml/min but ≥ 30 ml/min, diabetes mel...
Source: Trials - Category: Research Source Type: clinical trials