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

Maimónides Biomedical Research Institute of Córdoba

Status and phase: Completed; Phase 2

Conditions: Severe Acute Respiratory Syndrome; Covid19; Distress Respiratory Syndrome

Treatments: Drug: Best available treatment; Drug: Antithrombin + best available treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04745442

ANTITROMBINA

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

48 participants in 2 patient groups

Best available treatment + Antithrombin

Experimental group

Description:

The subject will be treated with Antithrombin (50 IU/Kg/12h) for 72 hours and the best available treatment for COVID-19.

Treatment:

Drug: Antithrombin + best available treatment

Best available treatment

Active Comparator group

Description:

The subject will be treated with the best available treatment for COVID-19.

Treatment:

Drug: Best available treatment