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Hemostasis in COVID-19: an Adaptive Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04466670
Recruitment Status : Recruiting
First Posted : July 10, 2020
Last Update Posted : June 9, 2021
Sponsor:
Information provided by (Responsible Party):
Vanderson Geraldo Rocha, University of Sao Paulo General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: acetylsalicylic acid Drug: Unfractionated heparin nebulized Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 379 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dynamics of Hemostatic Parameters in COVID-19 and Comparison of Intervention Strategies Through Adaptive Clinical Trial
Actual Study Start Date : July 11, 2020
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : May 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: phase 1
Observational arm
Experimental: phase 2A
Acetylsalicylic acid
 Drug: acetylsalicylic acid
acetylsalicylic acid (ASA) 100 mg daily PO up to 14 days OR arterial oxygen saturation greater than or equal to 92% on room air OR PaO2 to FiO2 ratio greater than 200 for 2 consecutive days, whichever is first.
Other Name: aspirin
Experimental: phase 2B
inhaled unfractionated heparin
 Drug: Unfractionated heparin nebulized
unfractionated heparin - 25,000 U/ 5 ml nebulized inhalation every 6 hours up to 14 days OR arterial oxygen saturation greater than or equal to 92% on room air OR PaO2 to FiO2 ratio greater than 200 for 2 consecutive days, whichever is first.
Placebo Comparator: Placebo
Placebo arm for Phase 2A
 Drug: acetylsalicylic acid
acetylsalicylic acid (ASA) 100 mg daily PO up to 14 days OR arterial oxygen saturation greater than or equal to 92% on room air OR PaO2 to FiO2 ratio greater than 200 for 2 consecutive days, whichever is first.
Other Name: aspirin


Outcome Measures
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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.


Eligibility Criteria
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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.

  • 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
Contacts and Locations
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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         
Sub-Investigator: Giancarlo Fatobene, MD         
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Vanderson Rocha University of Sao Paulo General Hospital
More Information
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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, Quere 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.

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: June 9, 2021
Last Verified: June 2021

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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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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Aspirin
Heparin
Calcium heparin
 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
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics