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Hemostasis in COVID-19: an Adaptive Clinical Trial | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Hemostasis in COVID-19: an Adaptive Clinical Trial

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

NCT04466670•University of Sao Paulo General Hospital

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+9 more criteria

Locations (1)

Vanderson Rocha

São Paulo, Brazil

Key Dates

Start Date

July 11, 2020

Primary Completion Date

December 30, 2021

Completion Date

May 30, 2022

Last Updated

June 9, 2021

Enrollment

379

ESTIMATED participants

Conditions

COVID-19

Interventions

acetylsalicylic acid

DRUG

Unfractionated heparin nebulized

DRUG

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COVID-19

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 9, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Hemostasis in COVID-19: an Adaptive Clinical Trial

Inclusion Criteria

Exclusion Criteria

A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes

Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments

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