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.

CAPSID

Overall study

Acronym	ISRCTN	EudraCT	NCT (clinicaltrials.gov)	DRKS
CAPSID2020-DRK-BSD		2020-001310-38

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

COVID-19 infection

Target population

Age

18-75

Inclusion criteria

Patients with SARS-CoV-2 infection and:

Age ≥ 18 years and ≤ 75 years
SARS-CoV-2 infection confirmed by PCR (BAL, sputum, nasal and/or pharyngeal swap)
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
Written informed consent by patient or legally authorized representative

Exclusion criteria

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

Study 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.

Clinical Trials