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

Maimónides Biomedical Research Institute of Córdoba48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Covid19 Severe Acute Respiratory Syndrome Distress Respiratory Syndrome

Interventions

Antithrombin + best available treatmentDRUG

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

Best available treatmentDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital Universitario Reina Sofía

Córdoba, Spain

Outcomes

Primary Outcomes

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

Time frame: At day 31 after randomization or hospital discharge (whichever occurs first)

Secondary Outcomes

Time to clinical improvement (decreased risk of developing SARS or death)

Time (in days) to improvement in the National Early Warning (NEWS) Score 2. Defined as the time, in days, from the start of treatment a two-point improvement on this scale.

Time frame: At day 31 after randomization or hospital discharge (whichever occurs first)

Evaluate the improvement of the oxygenation index - PaO2 / FiO2- at 24 and 48 hours.

Time frame: At 24 and 48 hours.

Improvement of the analytical parameters: time (in days) until the tendency to normalization (decrease >= 20%) of DD, ferritin, LDH, PCR and IL-6; the criteria reached before will be used.

Improvement of the analytical parameters: time (in days) until the tendency to normalization (decrease \>= 20%) of DD, ferritin, LDH, PCR and IL-6; the criteria reached before will be used.

Time frame: At day 31 after randomization or hospital discharge (whichever occurs first)

Time (in days) until improvement in oxygenation: - Time until the SpO2 / FiO2 ratio exceeds the worst SpO2 / FiO2 prior to AT treatment.

Time until the absence of oxygen need to maintain a basal saturation \>= 92%.

Time frame: At day 31 after randomization or hospital discharge (whichever occurs first)

Data from ClinicalTrials.gov

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