COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04745442

Ángel Salvatierra, MD

Maimonides Biomedical Research Institute of Cordoba, uicec@imibic.org (PI email not reported)

2021-02-09

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: age >= 18 and < 85 years covid-19 diagnosis confirmed. radiological image compatible with covid-19 present any of the following clinical-functional criteria considered risk: respiratory distress: tachypnea > 26 breaths / minute pao2 / fio2 oxygenation index # 300 alteration of one or more of the following parameters: c.i. dd> 1,000 µg / l c.ii. ferritin> 800 ng / ml 4.c.iii. lymphocytes <800 cells / µl 4.c.iv. pcr> 100 mg / l 4.c.v. ldh> 500 u / l c.vi. il-6> 15 pg / ml direct or delegated verbal informed consent

- signs of active bleeding - immunosuppression by cancer or transplant - intolerance or allergy to at or its components - pregnancy

2

Maimónides Biomedical Research Institute of Córdoba

18

84

Spain

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

48

Combined variable: mortality or worsening rate with need for non-invasive mechanical ventilation or with need for invasive mechanical ventilation

None

Phase 2

[{"arm_notes": "", "treatment_id": 103, "treatment_name": "Antithrombin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]