Clinical trial NCT04466670: Hemostasis in COVID-19: an Adaptive Clinical Trial
Official title: Dynamics of Hemostatic Parameters in COVID-19 and Comparison of Intervention Strategies Through Adaptive Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: COVID-19
Keywords: SARS-CoV-2
Thrombosis
Coagulopathy
Anticoagulation
Respiratory failure
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2020-07-10
Enrollment: 379
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Hypercoagulability has been demonstrated in COVID-19, leading to respiratory distress and increased mortality. This is an adaptive clinical trial to compare the efficacy and safety of two experimental strategies in patients with COVID-19: ASA or inhaled UFH associated with standard VTE prophylaxis.


Eligibility criteria: Inclusion Criteria:

* Adult ≥18 years of age at time of enrollment
* Subjects with a positive COVID-19 diagnosis by RT-PCR or serologic testing
* Subject (or legally authorized representative) must be willing, understanding and able to provide written informed consent.
* Only at phase 2:

  * onset of symptoms must not exceed 4 weeks
  * ICU patients
  * PaO2 to FiO2 ratio \< 200

Exclusion Criteria:

1. General

   * Indications for therapeutic anticoagulation
   * History of chronic lung disease oxygen dependent
   * Pregnancy
   * Death considered imminent and inevitable within 24 hours
   * Patients under exclusive palliative care
   * Participation in another trial of investigational drug
   * Body weight \< 40 Kg
   * Total bilirubin \> 20 mg/dL
   * Severe active bleeding
   * Persistent GI bleeding
   * Known allergy to UFH or LMWH
   * History of heparin-induced thrombocytopenia (HIT) within the past 6 months
2. Exclusion criteria at phase 1

   * Platelet count \< 25,000/mm3
   * Bacterial endocarditis
3. Exclusion criteria at phase 2

   * Platelet count \< 50,000/mm3
   * History of surgery in the last 30 days
   * Intervention A: allergy to ASA and long-term use of antiplatelet drug
   * Intervention B: inhaled nitric oxide use

Primary outcomes:
measure: Hospital discharge - alive / death
timeFrame: 30 days
Secondary outcomes:
measure: Length of mechanical ventilation free days
timeFrame: 30 days
measure: Length of renal replacement therapy free days
timeFrame: 30 days
measure: Number of documented venous thromboembolism or arterial thrombosis
timeFrame: 3 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Vanderson Rocha
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Vanderson Rocha
role: PRINCIPAL_INVESTIGATOR
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