A Clinical Trial of Convalescent Plasma Compared to Best Supportive Care for Treatment of Patients With Severe COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, prospective, multicenter, open label clinical trial of convalescent
      plasma compared to best supportive care for treatment of patients with severe COVID-19.

      The aim of the study is to explore the therapeutic effect of convalescent plasma transfusions
      on the survival and course of disease of patients with severe COVID-19. Convalescent plasma
      will be collected from recovered COVID-19 patients.

      Patients with severe COVID-19 will be randomly assigned to two groups. Patients in the
      treatment group will receive covalescent plasma (250 - 325 ml) on days 1, 3 and 5. Patients
      in the control group will receive best supportive care. Clinical condition in all patients
      will be evaluated on day 14. In case of progressive COVID-19 on day 14 compared to baseline,
      patients in the control group may be switched to treatment with convalescent plasma on days
      15, 17 and 19.

      Fifty-three patients will be included in each group. Data of each patient will be collected
      until discharge but nor longer than day 60.
    

Detailed description: 
      This is a randomized, prospective, multicentre, open label clinical trial of convalescent
      plasma compared to best supportive care for treatment of patients with severe COVID-19.

      The primary Endpoint is a dichotomous composite endpoint of survival and no longer fulfilling
      criteria of severe COVID-19 within 21 days after randomization. All criteria must be met in
      order to fulfil the primary endpoint.

      Key secondary endpoints are time to clinical improvement (defined as time from randomization
      to an improvement of two points on the WHO R&D Blueprint seven-category ordinal scale for
      clinical improvement), the frequency and severity of adverse events and the case fatality
      rate on day 21, 35 and 60. Further secondary endpoints refer to the course of anti-SARS-CoV-2
      antibodies in plasma donors and treated patients and the impact of donor criteria on the
      effectiveness of plasma units.

      Patients with severe COVID-19 defined by a respiratory rate ≥ 30 breaths / minute under
      ambient air or the requirement of any type of ventilation support or the need for ICU
      treatment can be included in the trial. It is planned to enrol 106 patients. Patients will be
      stratified according to ventilation support and/or extracorporeal oxygenation and/or ICU
      treatment and will be equally asigned to two groups. The treatment group receives
      convalescent plasma (250 - 325 ml) on day 1, 3 and 5 and the control group will receive best
      supportive care. Clinical condition in all patients will be evaluated on day 14. In case of
      progressive COVID-19 on day 14 compared to baseline (i.e. day 0), patients in the control
      group may be switched to treatment with convalescent plasma on days 15, 17 and 19. A patient
      switching from the control group to convalescent plasma group because of progressive COVID-19
      on day 14 will be considered as failure of the primary endpoint at final evaluation of the
      primary endpoint on day 21.
    

Intervention name(s): Convalesscent Plasma
Intervention type(s): Drug
Intervention description(s): Transfusion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: convalescent plasma