Status:
COMPLETED
Pilot Study of Antithrombin as Prophylaxis of Acute Respiratory Distress Syndrome in Patients With COVID-19
Lead Sponsor:
Maimónides Biomedical Research Institute of Córdoba
Conditions:
Covid19
Severe Acute Respiratory Syndrome
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
Pilot clinical trial, with a marketed drug -natural component of human plasma-, not approved for this indication, single-center, exploratory, open, randomized, controlled, to study the efficacy and sa...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Signs of active bleeding
- Immunosuppression by cancer or transplant
- Intolerance or allergy to AT or its components
- Pregnancy
Key Trial Info
Start Date :
April 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2021
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04745442
Start Date
April 27 2020
End Date
January 15 2021
Last Update
February 9 2021
Active Locations (1)
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1
Hospital Universitario Reina Sofía
Córdoba, Spain, 14004