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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Best available treatment + Antithrombin | Experimental | The subject will be treated with Antithrombin (50 IU/Kg/12h) for 72 hours and the best available treatment for COVID-19. |
|
| Best available treatment | Active Comparator | The subject will be treated with the best available treatment for COVID-19. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antithrombin + best available treatment | Drug | The subject will be treated with Antithrombin (50 IU/Kg/12h) for 72 hours and the best available treatment for COVID-19. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At day 31 after randomization or hospital discharge (whichever occurs first) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At day 31 after randomization or hospital discharge (whichever occurs first) |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Ángel Salvatierra, MD | Hospital General Universitario Reina Sofía de Murcia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Reina Sofía | Córdoba | 14004 | Spain |
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The information will be provided after the results are published in a journal.
Upon request to uicec@imibic.org
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| Best available treatment | Drug | The subject will be treated with the best available treatment for COVID-19. |
|
| 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. |
| 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. | At day 31 after randomization or hospital discharge (whichever occurs first) |
| 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%. | At day 31 after randomization or hospital discharge (whichever occurs first) |
| Time to radiological improvement in radiological report. | Time to radiological improvement in radiological report. | At day 31 after randomization or hospital discharge (whichever occurs first) |
| Time (in days) of non-invasive mechanical ventilation. | Time (in days) of non-invasive mechanical ventilation. | At day 31 after randomization or hospital discharge (whichever occurs first) |
| Time (in days) of invasive mechanical ventilation. | Time (in days) of invasive mechanical ventilation. | At day 31 after randomization or hospital discharge (whichever occurs first) |
| Mortality rate in hospital and one month after pharmacological intervention. | Mortality rate in hospital and one month after pharmacological intervention. | 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. | One month after pharmacological intervention. |
| Incidence of adverse events related to medication and its administration. | Incidence of adverse events related to medication and its administration. | At day 31 after randomization or hospital discharge (whichever occurs first) |
| Incidence in the appearance of allergic type hypersensitivity | Incidence in the appearance of Acne, Generalized urticaria, Chest tightness, Dyspnoea, Hypotension and/or Anaphylaxis. | At day 31 after randomization or hospital discharge (whichever occurs first) |
| Incidence of B19 parvovirus infection | Incidence of B19 parvovirus infection | At day 31 after randomization or hospital discharge (whichever occurs first) |
| Bleeding | Incidence of Bleeding | At day 31 after randomization or hospital discharge (whichever occurs first) |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D045169 | Severe Acute Respiratory Syndrome |
| D001261 | Pulmonary Atelectasis |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000991 | Antithrombins |
| ID | Term |
|---|---|
| D015842 | Serine Proteinase Inhibitors |
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000925 | Anticoagulants |
| D006401 | Hematologic Agents |
| D045506 | Therapeutic Uses |
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