Pilot Study of Antithrombin as Prophylaxis of Acute Respiratory Distress Syndrome in Patients With COVID-19

• Status: Completed
• Trial end date: 2021-01-15
• Target enrollment: 0
• Participant gender: All

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 safety of human Antithrombin in patients with confirmed COVID-19 disease and criteria high risk to develop SARS.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maimónides Biomedical Research Institute of Córdoba
• Treatments: Antithrombin III; Antithrombins

Criteria

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:

1. Respiratory distress: Tachypnea > 26 breaths / minute

2. PaO2 / FiO2 oxygenation index # 300

3. 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 Criteria:

• Signs of active bleeding

• Immunosuppression by cancer or transplant

• Intolerance or allergy to AT or its components

• Pregnancy