COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04433910

Hubert Schrezenmeier, Prof.Dr.

h.schrezenemeier@blutspende.de

2020-06-16

Completed

RCT

Randomized

Crossover

Open label

multi-center

Treatment

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: respiratory rate ≥ 30 breaths / minute under ambient air requirement of any type of ventilation support needs icu treatment written informed consent by patient or legally authorized representative

accompanying diseases other than covid-19 with an expected survival time of less than 12 months. previous treatment with any sars-cov-2-convalescent plasma 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 und severe emphysema chronic heart failure nyha >= 3 and/or pre-existing reduction of left ventricular ejection fraction to ≤ 30% shock of any type requiring ≥ 0.5 µg/kg/min noradrenaline (or equivalent) or requiring more than two types of vasopressor medication for more than 8 hours liver cirrhosis child c liver failure: bilirubin > 5xuln and elevation of alt /ast (at least one >10xuln). any history of adverse reactions to plasma proteins known deficiency of immunoglobulin a pregnancy breastfeeding women volume overload until sufficiently treated participation in another clinical trial with an investigational medicinal product

2

Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-Hessen

18

75

Germany

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

106

Composite endpoint of survival and no longer fulfilling criteria of severe COVID-19.

None

Phase 2

[{"arm_notes": "", "treatment_id": 322, "treatment_name": "Convalescent plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]