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

NCT04745442 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2021-02-09

No results posted yet for this study

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.

Conditions

  • Covid19
  • Severe Acute Respiratory Syndrome
  • Distress Respiratory Syndrome

Interventions

DRUG

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.

DRUG

Best available treatment

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

Sponsors & Collaborators

  • Maimónides Biomedical Research Institute of Córdoba

    lead OTHER

Principal Investigators

  • Ángel Salvatierra, MD · Hospital Universitario Reina Sofía

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-27
Primary Completion
2020-12-20
Completion
2021-01-15

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04745442 on ClinicalTrials.gov