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

Pilot study of antithrombin as prophylaxis of acute respiratory distress syndrome in patients with COVID-19

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001659-42-ES

Enrollment

Registered

2020-04-20

Start date

2020-04-18

Completion date

Unknown

Last updated

2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Confirmed SARS-CoV-2 respiratory infection with poor prognostic factors MedDRA version: 20.0 Level: LLT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.1 Level: PT Classification code 10061982 Term: Severe acute respiratory syndrome System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Anbinex Product Name: HUMAN ANTITHROMBIN Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Antithrombin III Other descriptive name: HUMAN ANTITHROMBIN

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age = 18 and 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 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

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

Design outcomes

Primary

Measure	Time frame
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. - To evaluate the improvement in analytical risk parameters for ARDS at 24, 48 and 72 hours. - To evaluate the radiological improvement. - To evaluate the rate of need for non-invasive and invasive mechanical ventilation. - To evaluate the time of use of mechanical ventilation. - To evaluate the mortality rate in hospital and one month after the pharmacological intervention. - To reviews the safety profile of the established treatment. - 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.	—

Measure

Time frame

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. - To evaluate the improvement in analytical risk parameters for ARDS at 24, 48 and 72 hours. - To evaluate the radiological improvement. - To evaluate the rate of need for non-invasive and invasive mechanical ventilation. - To evaluate the time of use of mechanical ventilation. - To evaluate the mortality rate in hospital and one month after the pharmacological intervention. - To reviews the safety profile of the established treatment. - 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.

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Daily.;Secondary end point(s): EFFICACY VARIABLES 1. Time to clinical improvement (decreased risk of developing ARDS 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. 2. Evaluate the improvement of the oxygenation index - PaO2 / FiO2- at 24 and 48 hours. 3. 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. 4. 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%. 5. Time to radiological improvement in radiological report. 6. Time (in days) of non-invasive mechanical ventilation. 7. Time (in days) of invasive mechanical ventilation. 8. Mortality rate in hospital and one month after pharmacological intervention. 9. Percentage of patients who suffer any adverse effect related to pharmacological intervention. SAFETY VARIABLES 1. Incidence of adverse events related to medication and its administration. 2. Incidence in the appearance of allergic type hypersensitivity: 2.1. Acne 2.2. Generalized urticaria 2.3. Chest tightness 2.4. Dyspnoea 2.5. Hypotension 2.6. Anaphylaxis 3. Incidence of parvovirus B19 infection. 4. Bleeding.	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Daily.;Secondary end point(s): EFFICACY VARIABLES 1. Time to clinical improvement (decreased risk of developing ARDS 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. 2. Evaluate the improvement of the oxygenation index - PaO2 / FiO2- at 24 and 48 hours. 3. 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. 4. 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%. 5. Time to radiological improvement in radiological report. 6. Time (in days) of non-invasive mechanical ventilation. 7. Time (in days) of invasive mechanical ventilation. 8. Mortality rate in hospital and one month after pharmacological intervention. 9. Percentage of patients who suffer any adverse effect related to pharmacological intervention. SAFETY VARIABLES 1. Incidence of adverse events related to medication and its administration. 2. Incidence in the appearance of allergic type hypersensitivity: 2.1. Acne 2.2. Generalized urticaria 2.3. Chest tightness 2.4. Dyspnoea 2.5. Hypotension 2.6. Anaphylaxis 3. Incidence of parvovirus B19 infection. 4. Bleeding.

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Countries

Spain

Contacts

Public ContactAntonio Luque

Fundación para la Investigación Biomédica de Córdoba

uicec@imibic.org0034671596070

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026