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

NCT04745442 | Completed Phase 2

• 1 other identifier: ANTITROMBINA
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Antithrombin; COVID-19; Distress Respiratory Syndrome

Outcome Measures

Primary Outcomes (1)

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

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

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

Secondary Outcomes (13)

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

  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.

  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.

  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.

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

• Time to radiological improvement in radiological report.

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

Study Arms (2)

Best available treatment + Antithrombin

EXPERIMENTAL

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

Drug: Antithrombin + best available treatment

Best available treatment

ACTIVE COMPARATOR

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

Drug: Best available treatment

Interventions

Antithrombin + best available treatment 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 + Antithrombin

Best available treatment DRUG

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

Best available treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Respiratory distress: Tachypnea \> 26 breaths / minute
• PaO2 / FiO2 oxygenation index # 300
• 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

You may not qualify if:

• Signs of active bleeding
• Immunosuppression by cancer or transplant
• Intolerance or allergy to AT or its components
• Pregnancy

Sponsors & Collaborators

• Maimónides Biomedical Research Institute of Córdoba: lead

Study Sites (1)

Hospital Universitario Reina Sofía

Córdoba, 14004, Spain

Location

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome; Pulmonary Atelectasis

Interventions

Antithrombins

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Serine Proteinase Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Anticoagulants; Hematologic Agents; Therapeutic Uses

Study Officials

• Ángel Salvatierra, MD

  Hospital Universitario Reina Sofía

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 9, 2021
• Study Start: April 27, 2020
• Primary Completion: December 20, 2020
• Study Completion: January 15, 2021
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The information will be provided after the results are published in a journal.
• Access Criteria: Upon request to uicec@imibic.org

Locations

ES (1)