Clinical trial NCT04745442: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Covid19
Severe Acute Respiratory Syndrome
Distress Respiratory Syndrome
Keywords: Antithrombin
COVID-19
Distress Respiratory Syndrome
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

  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

Primary outcomes:
measure: Combined variable: mortality or worsening rate with need for non-invasive mechanical ventilation or with need for invasive mechanical ventilation
timeFrame: At day 31 after randomization or hospital discharge (whichever occurs first)
Secondary outcomes:
measure: Time to clinical improvement (decreased risk of developing SARS or death)
timeFrame: At day 31 after randomization or hospital discharge (whichever occurs first)
measure: Evaluate the improvement of the oxygenation index - PaO2 / FiO2- at 24 and 48 hours.
timeFrame: At 24 and 48 hours.
measure: 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.
timeFrame: At day 31 after randomization or hospital discharge (whichever occurs first)
measure: Time (in days) until improvement in oxygenation: - Time until the SpO2 / FiO2 ratio exceeds the worst SpO2 / FiO2 prior to AT treatment.
timeFrame: At day 31 after randomization or hospital discharge (whichever occurs first)
measure: Time to radiological improvement in radiological report.
timeFrame: At day 31 after randomization or hospital discharge (whichever occurs first)
measure: Time (in days) of non-invasive mechanical ventilation.
timeFrame: At day 31 after randomization or hospital discharge (whichever occurs first)
measure: Time (in days) of invasive mechanical ventilation.
timeFrame: At day 31 after randomization or hospital discharge (whichever occurs first)
measure: Mortality rate in hospital and one month after pharmacological intervention.
timeFrame: One month after pharmacological intervention.
measure: Percentage of patients who suffer any adverse effect related to pharmacological intervention.
timeFrame: One month after pharmacological intervention.
measure: Incidence of adverse events related to medication and its administration.
timeFrame: At day 31 after randomization or hospital discharge (whichever occurs first)
measure: Incidence in the appearance of allergic type hypersensitivity
timeFrame: At day 31 after randomization or hospital discharge (whichever occurs first)
measure: Incidence of B19 parvovirus infection
timeFrame: At day 31 after randomization or hospital discharge (whichever occurs first)
measure: Bleeding
timeFrame: At day 31 after randomization or hospital discharge (whichever occurs first)
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
Study officials:
affiliation: Hospital Universitario Reina Sofía
name: Ángel Salvatierra, MD
role: PRINCIPAL_INVESTIGATOR
References: