Pilot Study of Antithrombin as Prophylaxis of Acute Respiratory Distress Syndrome in Patients With COVID-19
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Best available treatment + Antithrombin 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
The subject will be treated with Antithrombin (50 IU/Kg/12h) for 72 hours and the best available treatment for COVID-19.
|
| Active Comparator: Best available treatment The subject will be treated with the best available treatment for COVID-19. |
Drug: Best available treatment
The subject will be treated with the best available treatment for COVID-19.
|
Outcome Measures
Primary Outcome Measures
- 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)]
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) [At day 31 after randomization or hospital discharge (whichever occurs first)]
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. [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. [At day 31 after randomization or hospital discharge (whichever occurs first)]
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. [At day 31 after randomization or hospital discharge (whichever occurs first)]
Time until the absence of oxygen need to maintain a basal saturation >= 92%.
- Time to radiological improvement in radiological report. [At day 31 after randomization or hospital discharge (whichever occurs first)]
Time to radiological improvement in radiological report.
- Time (in days) of non-invasive mechanical ventilation. [At day 31 after randomization or hospital discharge (whichever occurs first)]
Time (in days) of non-invasive mechanical ventilation.
- Time (in days) of invasive mechanical ventilation. [At day 31 after randomization or hospital discharge (whichever occurs first)]
Time (in days) of invasive mechanical ventilation.
- Mortality rate in hospital and one month after pharmacological intervention. [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. [One month after pharmacological intervention.]
Percentage of patients who suffer any adverse effect related to pharmacological intervention.
- Incidence of adverse events related to medication and its administration. [At day 31 after randomization or hospital discharge (whichever occurs first)]
Incidence of adverse events related to medication and its administration.
- Incidence in the appearance of allergic type hypersensitivity [At day 31 after randomization or hospital discharge (whichever occurs first)]
Incidence in the appearance of Acne, Generalized urticaria, Chest tightness, Dyspnoea, Hypotension and/or Anaphylaxis.
- Incidence of B19 parvovirus infection [At day 31 after randomization or hospital discharge (whichever occurs first)]
Incidence of B19 parvovirus infection
- Bleeding [At day 31 after randomization or hospital discharge (whichever occurs first)]
Incidence of Bleeding
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Universitario Reina Sofía | Córdoba | Spain | 14004 |
Sponsors and Collaborators
- Maimónides Biomedical Research Institute of Córdoba
Investigators
- Principal Investigator: Ángel Salvatierra, MD, Hospital Universitario Reina Sofía
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ANTITROMBINA