Covid19, Distress Respiratory Syndrome, Severe Acute Respiratory Syndrome
Conditions
Keywords
Antithrombin, COVID-19, Distress Respiratory Syndrome
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.
Interventions
DRUGAntithrombin + 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.
The subject will be treated with the best available treatment for COVID-19.
Sponsors
Maimónides Biomedical Research Institute of Córdoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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: 1. Respiratory distress: Tachypnea \> 26 breaths / minute 2. PaO2 / FiO2 oxygenation index # 300 3. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 |
| 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. |
Countries
Spain
Outcome results
None listed