COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001549-38/DE

Gesundheit Nord gGmbH - Institut für Pharmakologie

i.puentmann@pharmakologie-bremen.de

2020-04-06

Terminated

RCT

Randomized

Parallel

Open label

multi-center

Treatment

Patients 18 years and older SARS-CoV-2 infection confirmed by PCR in any specimen < 9 days prior to randomization Admitted to the hospital ward or the ICU due to COVID-19 SpO2 ≤ 94% on room air OR oxygen demand OR breathing support Written informed consent obtained

Patient's non-consent or inability to informed consent Pregnant or breastfeeding women Subjects pretreated with one of the active study drugs in the past 29 days Anticipated transfer within 72 hours to a non-study hospital Severe co-morbidity with life expectancy < 3 months according to investigators opinion AST or ALT > 5 times the upper limit of normal Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30 mL/min) Contraindications to any of the active study drugs Subjects participating in a potentially confounding drug or device trial during the course of the study in the last 29 days Any reason why, in the opinion of the investigators, the patient should not participate

2

Gesundheit Nord gGmbH

18

100

Germany

Severe disease at enrollment

6: Severe disease at enrollment

400

improvement of the clinical status on the ordinal 7-point severity-scale at day 15: 1. Not hospitalized, no limitations on activities, 2. Not hospitalized, limitation on activities, 3. Hospitalized, not requiring supplemental oxygen, 4. Hospitalized, requiring supplemental oxygen, 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices, 6. Hospitalized, on invasive mechanical ventilation or ECMO, 7. Death

Declared number of arm (2.0) differs from found arms (1.0)

Phase 3

[{"arm_notes": "", "treatment_id": 1099, "treatment_name": "Remdesivir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]