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

Phase 2

Completed

• Conditions: Covid19; Severe Acute Respiratory Syndrome; Distress Respiratory Syndrome
• Interventions: Drug: Antithrombin + best available treatment; Drug: Best available treatment

• Registration Number: NCT04745442
• Lead Sponsor: Maimónides Biomedical Research Institute of Córdoba

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-27
• Primary Completion: 2020-12-20
• Study Completion: 2021-01-15
• Status Verified: 2021-02
• Study First Submitted: 2021-02-08
• Study First Submitted QC: 2021-02-08
• Last Update Submitted: 2021-02-08
• Study First Posted: 2021-02-09
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Best available treatment + Antithrombin	Antithrombin + 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.
Best available treatment	Best available treatment	The subject will be treated with the best available treatment for COVID-19.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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 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.
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
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.
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.
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%.
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.

Trial Locations

Locations (1)

Hospital Universitario Reina Sofía; 🇪🇸 Córdoba, Spain