Hemostasis in COVID-19: an Adaptive Clinical Trial

June 4, 2021 updated by: Vanderson Geraldo Rocha, University of Sao Paulo General Hospital

Dynamics of Hemostatic Parameters in COVID-19 and Comparison of Intervention Strategies Through Adaptive Clinical Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

379

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05403-000
        • Recruiting
        • Vanderson Rocha
        • Contact:
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • aspirin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital discharge - alive / death
Time Frame: 30 days
Number of COVID-19 positive patients who are alive within 30 days of symptoms onset
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of mechanical ventilation free days
Time Frame: 30 days
Comparison of length of mechanical ventilation free days between each treatment arm
30 days
Length of renal replacement therapy free days
Time Frame: 30 days
Comparison of length of renal replacement therapy free days between each treatment arm
30 days
Number of documented venous thromboembolism or arterial thrombosis
Time Frame: 3 months
Comparison of number of thrombosis events between each treatment arm.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Vanderson Rocha, University of Sao Paulo General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 11, 2020

Primary Completion (ANTICIPATED)

December 30, 2021

Study Completion (ANTICIPATED)

May 30, 2022

Study Registration Dates

First Submitted

July 8, 2020

First Submitted That Met QC Criteria

July 8, 2020

First Posted (ACTUAL)

July 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 9, 2021

Last Update Submitted That Met QC Criteria

June 4, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 33788820.9.0000.0068

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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