TrialX
Image

Hemostasis in COVID-19: an Adaptive Clinical Trial

Hemostasis in COVID-19: an Adaptive Clinical Trial

Recruiting
18 years and older
All
Phase 3

Overview

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.

Eligibility

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

Study details
    Covid 19

NCT04466670

University of Sao Paulo General Hospital

16 February 2024

Step 1 Get in touch with the nearest study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team


Email

View email

Phone

Phone country flag

View phone
Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.