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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-27

Study Completion Date

2021-01-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Covid19 Severe Acute Respiratory Syndrome Distress Respiratory Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Best available treatment + Antithrombin

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

Group Type EXPERIMENTAL

Antithrombin + best available treatment

Intervention Type DRUG

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

Best available treatment

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

Group Type ACTIVE_COMPARATOR

Best available treatment

Intervention Type DRUG

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

Interventions

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Antithrombin + best available treatment

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

Intervention Type DRUG

Best available treatment

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

Intervention Type DRUG

Eligibility Criteria

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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