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Completed

NCT Number: NCT04745442

Pilot Study of Antithrombin as Prophylaxis of Acute Respiratory Distress Syndrome in Patients With COVID-19

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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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Distress Respiratory Syndrome Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral Pulmonary Atelectasis RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Severe Acute Respiratory Syndrome Virus Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Universitario Reina Sofía

Córdoba, 14004, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Best Available Treatment

Drug

The subject will be treated with the best available treatment for COVID-19.

Primary outcomes

  1. 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 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 outcomes

  1. Time to clinical improvement (decreased risk of developing SARS or death)

    Time frame: 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.

  2. Evaluate the improvement of the oxygenation index - PaO2 / FiO2- at 24 and 48 hours.

    Time frame: At 24 and 48 hours.

    Evaluate the improvement of the oxygenation index - PaO2 / FiO2- at 24 and 48 hours.

  3. 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 frame: 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.

  4. Time (in days) until improvement in oxygenation: - Time until the SpO2 / FiO2 ratio exceeds the worst SpO2 / FiO2 prior to AT treatment.

    Time frame: At day 31 after randomization or hospital discharge (whichever occurs first)

    Time until the absence of oxygen need to maintain a basal saturation >= 92%.

  5. Time to radiological improvement in radiological report.

    Time frame: At day 31 after randomization or hospital discharge (whichever occurs first)

    Time to radiological improvement in radiological report.

  6. Time (in days) of non-invasive mechanical ventilation.

    Time frame: At day 31 after randomization or hospital discharge (whichever occurs first)

    Time (in days) of non-invasive mechanical ventilation.

  7. Time (in days) of invasive mechanical ventilation.

    Time frame: At day 31 after randomization or hospital discharge (whichever occurs first)

    Time (in days) of invasive mechanical ventilation.

  8. Mortality rate in hospital and one month after pharmacological intervention.

    Time frame: One month after pharmacological intervention.

    Mortality rate in hospital and one month after pharmacological intervention.

  9. Percentage of patients who suffer any adverse effect related to pharmacological intervention.

    Time frame: One month after pharmacological intervention.

    Percentage of patients who suffer any adverse effect related to pharmacological intervention.

  10. Incidence of adverse events related to medication and its administration.

    Time frame: At day 31 after randomization or hospital discharge (whichever occurs first)

    Incidence of adverse events related to medication and its administration.

  11. Incidence in the appearance of allergic type hypersensitivity

    Time frame: 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.

  12. Incidence of B19 parvovirus infection

    Time frame: At day 31 after randomization or hospital discharge (whichever occurs first)

    Incidence of B19 parvovirus infection

  13. Bleeding

    Time frame: At day 31 after randomization or hospital discharge (whichever occurs first)

    Incidence of Bleeding

Sponsors and collaborators

Lead sponsor

Maimónides Biomedical Research Institute of Córdoba

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Feb 9, 2021
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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