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Hemostasis in COVID-19: an Adaptive Clinical Trial

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ClinicalTrials.gov Identifier: NCT04466670
Recruitment Status : Recruiting
First Posted : July 10, 2020
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
Vanderson Geraldo Rocha, University of Sao Paulo General Hospital

Brief Summary:
Hypercoagulability has been demonstrated in COVID-19, leading to respiratory distress and increased mortality. This is adaptive clinical trial to compare effectiveness and safety of four therapeutic strategies in hospital mortality in patients with COVID-19: standard prophylaxis, therapeutic dose anticoagulation, inhaled UFH associated with standard prophylaxis and ASA associated with standard prophylaxis.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: unfractionated Heparin Drug: Unfractionated heparin nebulized Drug: acetylsalicylic acid Drug: Enoxaparin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 310 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dynamics of Hemostatic Parameters in COVID-19 and Comparison of Intervention Strategies Through Adaptive Clinical Trial
Estimated Study Start Date : July 8, 2020
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : April 30, 2021

Arm Intervention/treatment
No Intervention: phase 1
Experimental: phase 2A Drug: unfractionated Heparin
Unfractionated heparin dosed to target anti-Xa level 0.3 - 0.7 IU/mL (if creatinine clearance less than 30ml/min), during at least 5 days AND arterial oxygen saturation greater than or equal to 92% or PaO2 to FiO2 ratio greater than 200 for 2 consecutive days.

Drug: Enoxaparin
Enoxaparin 1 mg/kg subcutaneously every 12 hours (if creatinine clearance greater than or equal to 30ml/min) during at least 5 days AND arterial oxygen saturation greater than or equal to 92% or PaO2 to FiO2 ratio greater than 200 for 2 consecutive days.

Experimental: phase 2B Drug: Unfractionated heparin nebulized
unfractionated heparin - 25,000 U/ 5 ml nebulized inhalation every 6 hours during at least 5 days AND arterial oxygen saturation greater than or equal to 92% or PaO2 to FiO2 ratio greater than 200 for 2 consecutive days associated to thromboprophylaxis institutional protocol.

Experimental: phase 2C Drug: acetylsalicylic acid
Aspirin (ASA) 100 mg daily PO during at least 5 days AND arterial oxygen saturation greater than or equal to 92% or PaO2 to FiO2 ratio greater than 200 for 2 consecutive days associated to thromboprophylaxis institutional protocol.




Primary Outcome Measures :
  1. Hospital discharge - alive / death [ Time Frame: 30 days ]
    Number of COVID-19 positive patients who are alive within 30 days of symptoms onset


Secondary Outcome Measures :
  1. Length of mechanical ventilation free days [ Time Frame: 30 days ]
    Comparison of length of mechanical ventilation free days between each treatment arm

  2. Length of renal replacement therapy free days [ Time Frame: 30 days ]
    Comparison of length of renal replacement therapy free days between each treatment arm

  3. Number of documented venous thromboembolism or arterial thrombosis [ Time Frame: 3 months ]
    Comparison of number of thrombosis events between each treatment arm.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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
    • Known allergy to UFH or LMWH
    • History of heparin-induced thrombocytopenia (HIT) within the past 6 months
    • Bacterial endocarditis
  2. Exclusion criteria at phase 1

    • Platelets < 25,000

  3. Exclusion criteria at phase 2

    • Platelets < 50,000
    • History of surgery in the last 30 days
    • Intervention C: allergy to ASS and long-term use of antiplatelet drug

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04466670


Locations
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Brazil
Vanderson Rocha Recruiting
Sao Paulo, Brazil, 05403-000
Contact: Vanderson Rocha, MD.PhD    +55-11-26617575    vanderson.rocha@hc.fm.usp.br   
Contact: Yeh-Li Ho, MD.PhD    +55-11-26616045    ho.yeh@hc.fm.usp.br   
Sub-Investigator: Yeh-Li Ho, MD.PhD         
Sub-Investigator: Elbio A D'Amico, MD.PhD         
Sub-Investigator: Paula R Villaca, MD.PhD         
Sub-Investigator: Cynthia Rotschild, MD         
Sub-Investigator: Erica Okazaki, MD         
Sub-Investigator: Tania RF Rocha, MPharm         
Sponsors and Collaborators
University of Sao Paulo General Hospital
Publications of Results:
Bikdeli B, Madhavan MV, Jimenez D, Chuich T, Dreyfus I, Driggin E, Nigoghossian C, Ageno W, Madjid M, Guo Y, Tang LV, Hu Y, Giri J, Cushman M, Quéré I, Dimakakos EP, Gibson CM, Lippi G, Favaloro EJ, Fareed J, Caprini JA, Tafur AJ, Burton JR, Francese DP, Wang EY, Falanga A, McLintock C, Hunt BJ, Spyropoulos AC, Barnes GD, Eikelboom JW, Weinberg I, Schulman S, Carrier M, Piazza G, Beckman JA, Steg PG, Stone GW, Rosenkranz S, Goldhaber SZ, Parikh SA, Monreal M, Krumholz HM, Konstantinides SV, Weitz JI, Lip GYH; Global COVID-19 Thrombosis Collaborative Group, Endorsed by the ISTH, NATF, ESVM, and the IUA, Supported by the ESC Working Group on Pulmonary Circulation and Right Ventricular Function. COVID-19 and Thrombotic or Thromboembolic Disease: Implications for Prevention, Antithrombotic Therapy, and Follow-Up: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Jun 16;75(23):2950-2973. doi: 10.1016/j.jacc.2020.04.031. Epub 2020 Apr 17. Review.

Other Publications:
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Responsible Party: Vanderson Geraldo Rocha, Full professor, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT04466670    
Other Study ID Numbers: 33788820.9.0000.0068
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vanderson Geraldo Rocha, University of Sao Paulo General Hospital:
SARS-CoV-2
Thrombosis
Coagulopathy
Anticoagulation
Respiratory failure
Additional relevant MeSH terms:
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Aspirin
Heparin
Calcium heparin
Enoxaparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics