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. 2022 Mar 4;2022(3):CD013739. doi: 10.1002/14651858.CD013739.pub2

NCT04745442.

Study name Pilot study of antithrombin as prophylaxis of acute respiratory distress syndrome in patients with COVID‐19
Starting date 27 April 2020
Contact information Maimónides Biomedical Research Institute of Córdoba
Hospital Universitario Reina Sofía
Córdoba, Spain, 14004
Methods Single‐centre, open‐label, parallel‐assignment RCT
Participants 48 participants, ≥ 18 to ≤ 85 years, female and male
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: tachypnoea > 26 breaths/min

    • PaO2/FiO2 oxygenation index # 300

    • alteration of ≥ 1 of the following parameters:

      • D‐dimer > 1000 µg/L. Ferritin > 800 ng/mL. Lymphocytes < 800 cells/µL. PCR > 100 mg/L. LDH > 500 U/L. 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
Interventions Experimental: best available treatment + antithrombin

  • The participant will be treated with antithrombin (50 IU/kg/12 h) for 72 h and the best available treatment for COVID‐19


Active comparator: best available treatment

  • The participant will be treated with the best available treatment for COVID‐19
Outcomes Primary

  • 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 randomisation or hospital discharge, whichever occurs first)


Secondary

  • Time to clinical improvement (decreased risk of developing SARS or death) (time frame: at day 31 after randomisation or hospital discharge, whichever occurs first)

  • Evaluate the improvement of the oxygenation index ‐ PaO2/FiO2‐ at 24 and 48 h (time frame: at 24 and 48 h)

  • Improvement of the analytical parameters: time (in days) until the tendency to normalisation (decrease ≥ 20%) of D‐dimer, ferritin, LDH, PCR and IL‐6; the criteria reached before will be used (time frame: at day 31 after randomisation 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 antithrombin treatment. (time frame: at day 31 after randomisation or hospital discharge, whichever occurs first)

  • Time to radiological improvement in radiological report (time frame: at day 31 after randomisation or hospital discharge, whichever occurs first)

  • Time (in days) of non‐invasive mechanical ventilation (time frame: at day 31 after randomisation or hospital discharge, whichever occurs first)

  • Time (in days) of invasive mechanical ventilation. (time frame: at day 31 after randomisation or hospital discharge, whichever occurs first)

  • Mortality rate in hospital and 1 month after pharmacological intervention (time frame: 1 month after pharmacological intervention)

  • Percentage of participants who suffer any AE related to pharmacological intervention (time frame: 1 month after pharmacological intervention)

  • Incidence of AEs related to medication and its administration (time frame: at day 31 after randomisation or hospital discharge, whichever occurs first)

  • Incidence in the appearance of allergic type hypersensitivity (time frame: At day 31 after randomisation or hospital discharge (whichever occurs first) )

  • Incidence of B19 parvovirus infection (time frame: at day 31 after randomisation or hospital discharge, whichever occurs first) 

  • Bleeding (time frame: at day 31 after randomisation or hospital discharge, whichever occurs first)
Notes NCT04745442 | No data provided