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 : June 9, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID-19 | Drug: acetylsalicylic acid Drug: Unfractionated heparin nebulized | Phase 2 |
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 |

Arm | Intervention/treatment |
---|---|
No Intervention: phase 1
Observational arm
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Experimental: phase 2A
Acetylsalicylic acid
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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 |
- Hospital discharge - alive / death [ Time Frame: 30 days ]Number of COVID-19 positive patients who are alive within 30 days of symptoms onset
- Length of mechanical ventilation free days [ Time Frame: 30 days ]Comparison of length of mechanical ventilation free days between each treatment arm
- Length of renal replacement therapy free days [ Time Frame: 30 days ]Comparison of length of renal replacement therapy free days between each treatment arm
- 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 |
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.
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Only at phase 2:
- onset of symptoms must not exceed 4 weeks
- ICU patients
- PaO2 to FiO2 ratio < 200
Exclusion Criteria:
-
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
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Exclusion criteria at phase 1
- Platelet count < 25,000/mm3
- Bacterial endocarditis
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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

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
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 |
Principal Investigator: | Vanderson Rocha | University of Sao Paulo General Hospital |
Other Publications:
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
SARS-CoV-2 Thrombosis Coagulopathy Anticoagulation Respiratory failure |
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 |