Study of antithrombin as prophylaxis of acute respiratory disease in patients with COVID-19

Phase 1

• Conditions: Confirmed SARS-CoV-2 respiratory infection with poor prognostic factors; MedDRA version: 20.0Level: LLTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.1Level: PTClassification code 10061982Term: Severe acute respiratory syndromeSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001659-42-ES
• Lead Sponsor: Fundación para la Investigación Biomédica de Córdoba

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-20
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

1. Age = 18 and <85 years
2. Diagnosis confirmed by COVID-19 PCR
3. Radiological image compatible with COVID-19
4. Present any of the following clinical-functional criteria considered RISK:
4.a. Respiratory distress: Tachypnea> 26 breaths / minute
4. b. PaO2 / FiO2 oxygenation index = 300
4.c. Alteration of one or more of the following parameters:
4.c.i. DD> 1,000 µg / L
4.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
4.c.vi. IL-6> 15 pg / mL
5. Direct or delegated verbal informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36

Exclusion Criteria

1. Signs of active bleeding
2. Immunosuppression by cancer or transplant
3. Intolerance or allergy to AT or its components
4. Pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Decrease the risk of developing ARDS and death in high-risk COVID-19 patients;Secondary Objective: - To evaluate the improvement in oxygenation at 12, 24, 48, 72 and 96 hours.<br>- To evaluate the improvement in analytical risk parameters for ARDS at 24, 48 and 72 hours.<br>- To evaluate the radiological improvement.<br>- To evaluate the rate of need for non-invasive and invasive mechanical ventilation.<br>- To evaluate the time of use of mechanical ventilation.<br>- To evaluate the mortality rate in hospital and one month after the pharmacological intervention.<br>- To reviews the safety profile of the established treatment.<br>- To Deepen in the anti-inflammatory mechanisms of AT.;Primary end point(s): Combined variable: mortality or worsening rate with need for non-invasive mechanical ventilation or with need for invasive mechanical ventilation.;Timepoint(s) of evaluation of this end point: Daily.