Back to resultsPilot Study of Antithrombin as Prophylaxis of Acute Respiratory Distress Syndrome in Patients With COVID-19
Primary Purpose
Covid19, Severe Acute Respiratory Syndrome, Distress Respiratory Syndrome
Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Antithrombin + best available treatment
Best available treatment
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring Antithrombin, COVID-19, Distress Respiratory Syndrome
Eligibility Criteria
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:
- 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
Exclusion Criteria:
- Signs of active bleeding
- Immunosuppression by cancer or transplant
- Intolerance or allergy to AT or its components
- Pregnancy
Sites / Locations
- Hospital Universitario Reina Sofía
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Best available treatment + Antithrombin
Best available treatment
Arm Description
The subject will be treated with Antithrombin (50 IU/Kg/12h) for 72 hours and the best available treatment for COVID-19.
The subject will be treated with the best available treatment for COVID-19.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Time to clinical improvement (decreased risk of developing SARS 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.
Evaluate the improvement of the oxygenation index - PaO2 / FiO2- at 24 and 48 hours.
Evaluate the improvement of the oxygenation index - PaO2 / FiO2- 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.
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.
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%.
Time to radiological improvement in radiological report.
Time to radiological improvement in radiological report.
Time (in days) of non-invasive mechanical ventilation.
Time (in days) of non-invasive mechanical ventilation.
Time (in days) of invasive mechanical ventilation.
Time (in days) of invasive mechanical ventilation.
Mortality rate in hospital and one month after pharmacological intervention.
Mortality rate in hospital and one month after pharmacological intervention.
Percentage of patients who suffer any adverse effect related to pharmacological intervention.
Percentage of patients who suffer any adverse effect related to pharmacological intervention.
Incidence of adverse events related to medication and its administration.
Incidence of adverse events related to medication and its administration.
Incidence in the appearance of allergic type hypersensitivity
Incidence in the appearance of Acne, Generalized urticaria, Chest tightness, Dyspnoea, Hypotension and/or Anaphylaxis.
Incidence of B19 parvovirus infection
Incidence of B19 parvovirus infection
Bleeding
Incidence of Bleeding
Full Information
NCT ID
NCT04745442
First Posted
February 8, 2021
Last Updated
February 8, 2021
Sponsor
Maimónides Biomedical Research Institute of Córdoba
1. Study Identification
Unique Protocol Identification Number
NCT04745442
Brief Title
Pilot Study of Antithrombin as Prophylaxis of Acute Respiratory Distress Syndrome in Patients With COVID-19
Official Title
Pilot Study of Antithrombin as Prophylaxis of Acute Respiratory Distress Syndrome in Patients With COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
April 27, 2020 (Actual)
Primary Completion Date
December 20, 2020 (Actual)
Study Completion Date
January 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maimónides Biomedical Research Institute of Córdoba
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Severe Acute Respiratory Syndrome, Distress Respiratory Syndrome
Keywords
Antithrombin, COVID-19, Distress Respiratory Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Best available treatment + Antithrombin
Arm Type
Experimental
Arm Description
The subject will be treated with Antithrombin (50 IU/Kg/12h) for 72 hours and the best available treatment for COVID-19.
Arm Title
Best available treatment
Arm Type
Active Comparator
Arm Description
The subject will be treated with the best available treatment for COVID-19.
Intervention Type
Drug
Intervention Name(s)
Antithrombin + best available treatment
Intervention Description
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
Intervention Name(s)
Best available treatment
Intervention Description
The subject will be treated with the best available treatment for COVID-19.
Primary Outcome Measure Information:
Title
Combined variable: mortality or worsening rate with need for non-invasive mechanical ventilation or with need for invasive mechanical ventilation
Description
Combined variable: mortality or worsening rate with need for non-invasive mechanical ventilation or with need for invasive mechanical ventilation
Time Frame
At day 31 after randomization or hospital discharge (whichever occurs first)
Secondary Outcome Measure Information:
Title
Time to clinical improvement (decreased risk of developing SARS or death)
Description
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.
Time Frame
At day 31 after randomization or hospital discharge (whichever occurs first)
Title
Evaluate the improvement of the oxygenation index - PaO2 / FiO2- at 24 and 48 hours.
Description
Evaluate the improvement of the oxygenation index - PaO2 / FiO2- at 24 and 48 hours.
Time Frame
At 24 and 48 hours.
Title
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.
Description
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.
Time Frame
At day 31 after randomization or hospital discharge (whichever occurs first)
Title
Time (in days) until improvement in oxygenation: - Time until the SpO2 / FiO2 ratio exceeds the worst SpO2 / FiO2 prior to AT treatment.
Description
Time until the absence of oxygen need to maintain a basal saturation >= 92%.
Time Frame
At day 31 after randomization or hospital discharge (whichever occurs first)
Title
Time to radiological improvement in radiological report.
Description
Time to radiological improvement in radiological report.
Time Frame
At day 31 after randomization or hospital discharge (whichever occurs first)
Title
Time (in days) of non-invasive mechanical ventilation.
Description
Time (in days) of non-invasive mechanical ventilation.
Time Frame
At day 31 after randomization or hospital discharge (whichever occurs first)
Title
Time (in days) of invasive mechanical ventilation.
Description
Time (in days) of invasive mechanical ventilation.
Time Frame
At day 31 after randomization or hospital discharge (whichever occurs first)
Title
Mortality rate in hospital and one month after pharmacological intervention.
Description
Mortality rate in hospital and one month after pharmacological intervention.
Time Frame
One month after pharmacological intervention.
Title
Percentage of patients who suffer any adverse effect related to pharmacological intervention.
Description
Percentage of patients who suffer any adverse effect related to pharmacological intervention.
Time Frame
One month after pharmacological intervention.
Title
Incidence of adverse events related to medication and its administration.
Description
Incidence of adverse events related to medication and its administration.
Time Frame
At day 31 after randomization or hospital discharge (whichever occurs first)
Title
Incidence in the appearance of allergic type hypersensitivity
Description
Incidence in the appearance of Acne, Generalized urticaria, Chest tightness, Dyspnoea, Hypotension and/or Anaphylaxis.
Time Frame
At day 31 after randomization or hospital discharge (whichever occurs first)
Title
Incidence of B19 parvovirus infection
Description
Incidence of B19 parvovirus infection
Time Frame
At day 31 after randomization or hospital discharge (whichever occurs first)
Title
Bleeding
Description
Incidence of Bleeding
Time Frame
At day 31 after randomization or hospital discharge (whichever occurs first)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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
Exclusion Criteria:
Signs of active bleeding
Immunosuppression by cancer or transplant
Intolerance or allergy to AT or its components
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ángel Salvatierra, MD
Organizational Affiliation
Hospital Universitario Reina Sofía
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Reina Sofía
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
The information will be provided after the results are published in a journal.
IPD Sharing Access Criteria
Upon request to uicec@imibic.org
Learn more about this trial
Pilot Study of Antithrombin as Prophylaxis of Acute Respiratory Distress Syndrome in Patients With COVID-19
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