As an infrastructure at the German Center for Infection Research (DZIF), the Clinical Trial Unit tracks DZIF's study activities in the “Healex Site Management System (SMS)”. Studies are sorted by indication and are continuously updated.

The study register has recently been expanded to include the category “COVID-19”. For the first time, not only DZIF study activities are presented here: In order to provide a comprehensive overview in the current pandemic situation of planned and already active COVID-19 studies in Germany, the Clinical Trial Unit is cooperating with researchers from various German Centers for Health Research and other networks.

For researchers: If your study is not yet included in our portal, please contact the project management of the Clinical Trial Unit (angela.steinbach@uk-koeln.de or vassiliki.dimitriou@uk-koeln.de).

CAPSID

AcronymISRCTNEudraCTNCT (clinicaltrials.gov)DRKS
CAPSID2020-DRK-BSD2020-001310-38

A randomized, prospective, open label clinical trial on the use of convalescent plasma compared to best supportive care in patients with severe COVID-19

Status: Active

Purpose / Objectives

Primary Outcome

To improve survival

AND

remove criteria of severe COVID-19 (CoV-2 infection) within 21 days after randomization

 

Secondary Outcomes

  • Time to clinical improvement on WHO R&D Blueprint seven-category ordinal scale by 2
  • Adverse events
  • Case fatality rate on days 21, 35 and 60
  • Length of hospital stay
  • Length of ICU stay
  • Duration of ventilation Support / ECMO
  • Time until negative SARS-CoV-2 PCR
  • Predictive value of comorbidities and inflammation markers
  • Feasibility of collection of plasma units
  • Kinetics of anti-SARS-CoV-2 antibodies in plasma of patients = plasma donors who recovered from a SARS-CoV-2 infection
  • Titer of anti-SARS-CoV-2 in transfused plasma units
  • Impact of donor characteristics on anti-SARS-CoV-2 humoral response
  • Course of anti-SARS-CoV-2 titer in patients
  • Effect of timing of plasma transfusions on outcome

 

Diagnosis

Patient attributes

Age

18-75

Inclusion criteria

Patients with SARS-CoV-2 infection and:

  1. Age ≥ 18 years and ≤ 75 years
  2. SARS-CoV-2 infection confirmed by PCR (BAL, sputum, nasal and/or pharyngeal swap)
  3. severe disease defined by at least one of the following:
    a. respiratory rate ≥ 30 breaths / minute under ambient air
    b. requirement of any type of ventilation support
    c. needs ICU Treatment
  4. Written informed consent by patient or legally authorized representative

 

Exclusion criteria

  1. Accompanying diseases other than COVID-19 with an expected survival time of
    less than 12 months
  2. In the opinion of the clinical team, progression to death is imminent and
    inevitable within the next 48 hours, irrespective of the provision of treatment
  3. Interval > 72 hours since start of ventilation support
  4. Not considered eligible for extracorporeal oxygenation support (even in case of
    severe ARDS according to Berlin classification with Horovitz-Index < 100 mg Hg)
  5. Chronic obstructive lung disease (COPD), stage 4
  6. Lung fibrosis with UIP pattern in CT and severe emphysema
  7. Chronic heart failure NYHA ≥ 3 and/or pre-existing reduction of left ventricular
    ejection fraction to ≤ 30%
  8. Cardiovascular failure requiring ≥ 0.5 µg/kg/min noradrenaline (or equivalent) or requiring more than two types of vasopressor medication
  9. Liver cirrhosis Child C
  10. Liver failure: Bilirubin > 5 x ULN and elevation of ALT or AST (> 10 x ULN)
  11. Any history of adverse reactions to plasma proteins
  12. Known deficiency of immunoglobulin A
  13. Pregnancy
  14. Breastfeeding women
  15. Volume overload until sufficiently treated
  16. Pulmonary edema
  17. Participation in another clinical trial for treatment of COVID-19

 

Trial design

  • Phase II
  • Multicenter
  • Prospective
  • Two-arm
  • Open Label

Intervention

Clinical Study to assess positive value of blood plasma from donors having built immunity against the new corona virus (SARS-CoV-2) transfused to patients suffering from SARS-CoV-2 infection.

 

Documents (password protected)

Responsibilities in overall trial

National Coordinating Investigator

Dr. med. Sixten Körper