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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04745442
• Other study ID #: ANTITROMBINA
• Status: Completed
• Phase: Phase 2
• Start date: April 27, 2020
• Est. completion date: January 15, 2021

Study information

• Verified date: February 2021
• Source: Maimónides Biomedical Research Institute of Córdoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 15, 2021
• Est. primary completion date: December 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Coronavirus Infections
• Covid19
• Distress Respiratory Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Severe Acute Respiratory Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitario Reina Sofía	Córdoba

Sponsors (1)

Lead Sponsor	Collaborator
Maimónides Biomedical Research Institute of Córdoba

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	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)
Secondary	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.
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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.
Secondary	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.
Secondary	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)
Secondary	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)
Secondary	Incidence of B19 parvovirus infection	Incidence of B19 parvovirus infection	At day 31 after randomization or hospital discharge (whichever occurs first)
Secondary	Bleeding	Incidence of Bleeding	At day 31 after randomization or hospital discharge (whichever occurs first)