CLINICAL TRIAL

Unfractionated heparin for COVID-19

Recruiting · 18+ · All Sexes · New York, NY

This study is evaluating whether anticoagulation may help improve outcomes for individuals with a blood clotting disorder.

See full description

About the trial for COVID-19

Eligible Conditions
Critical Illness · COVID-19

Treatment Groups

This trial involves 2 different treatments. Unfractionated Heparin is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Unfractionated heparin
DRUG
Fondapariniux
DRUG
Enoxaparin sodium
DRUG
Argatroban
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Unfractionated heparin
DRUG
Fondapariniux
DRUG
Enoxaparin sodium
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Heparin
FDA approved
Enoxaparin
FDA approved
Argatroban
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
You must be at least 18 years old to donate blood. show original
An intensive care unit patient on invasive mechanical ventilation, BiPAP, 100% non-rebreather mask, or high flow oxygen or supplemental oxygen of at least 4 liters per minute nasal cannula is significantly more likely to be discharged to home than a non-ICU patient on invasive mechanical ventilation, BiPAP, 100% non-rebreather mask, or high flow oxygen or supplemental oxygen of at least 4 liters per minute nasal cannula. show original
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 6 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 6 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Unfractionated heparin will improve 1 primary outcome and 3 secondary outcomes in patients with COVID-19. Measurement will happen over the course of 30 days.

30-day mortality
30 DAYS
Comparison of number of COVID-19 positive patients who have died within 30 days of starting treatment on each treatment arm
Length of Intensive Care Unit (ICU) Stay in Days
6 MONTHS
Comparison of length of ICU stay in days between each treatment arm.
Number of major and clinically relevant non-major bleeding events
6 MONTHS
Comparison of major and clinically-relevant non-major bleeding events on each treatment arm, as defined by the International Society of Thrombosis and Haemostasis (ISTH) criteria.
Number of documented venous thromboembolism (VTE), arterial thrombosis (stroke, myocardial infarction, other) and microthrombosis events
6 MONTHS
Comparison of number of documented VTE, arterial thrombosis and microthrombosis events on each treatment arm

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the common side effects of unfractionated heparin?

Unfractionated heparin may cause side effects that may outweigh any benefit for some patients. It is therefore important to monitor and record the side effects of heparin therapy.

Anonymous Patient Answer

Has unfractionated heparin proven to be more effective than a placebo?

Unfractionated heparin does not appear to be more effective than a placebo for prevention of VTE in elective surgical patients in the immediate post-operative period.

Anonymous Patient Answer

How many people get covid-19 a year in the United States?

The National Center for Population Health Research at the National Institute of Health's Clinical Center in Bethesda states that the estimated 2019 U.S. community-acquired cases in adults and the total number of deaths from all of these cases are 8,000 and 2,500, respectively. The United States CDC estimates that in the U.S. about 1.9 million people (3%) will be infected, with about 100,000 of these becoming seriously ill, 1–7% of which dying of their illness. Based upon these numbers, one new case of covid-19 will occur per 10,000 people in the U.S. each year.

Anonymous Patient Answer

What is covid-19?

Covid-19 can cause fever, and people may have trouble breathing when breathing in or out. If you do not feel well, call a healthcare professional. Some people can catch the virus that causes it by having close contact with someone with the virus, like caring for someone at home with the virus. In those cases, they should contact their health professional as soon as possible.\n

Anonymous Patient Answer

What are the signs of covid-19?

There were high positivity rates in most patients in the group of clinical suspicion for SARS-CoV-2, with some being false-positive. The positive rates of patients with clinical suspicion, but with negative SARS-CoV-2 tests, were higher. This suggests that SARS-CoV-2 detection with real-time reverse transcription-polymerase chain reaction testing using sample collection from the nasopharynx and oropharyngeal area is useful in clinical practice.

Anonymous Patient Answer

What are common treatments for covid-19?

Treatment for coronavirus diseases may include home remedies such as rest, fever reduction, and anti-inflammatory medication such as ibuprofen, but other medications may be taken in order to manage symptoms such as high cholesterol, high blood pressure, dehydration, and/or heart problems. The effects of coronavirus and treatments for covid-19 will likely continue to change as new insights are developed.

Anonymous Patient Answer

Can covid-19 be cured?

Covid-19 can be very difficult to treat, and may be an incurable disease. There are no reported cures for this disease, but a few promising treatments have been reported.

Anonymous Patient Answer

What causes covid-19?

There are no conclusive observations supporting a link between people with underlying disease and their exposure to SARS-CoV-2. This virus may be harmless for the vast majority of people but may have a serious effect in select groups such as the elderly and those with pre-existing illnesses or health disturbances.

Anonymous Patient Answer

Have there been other clinical trials involving unfractionated heparin?

Unfractionated heparin has been used in a small number of experimental trials. The only well-designed trial reporting positive clinical impact is the HIGHER trial. One study is registered as uncontrolled (a study funded by the manufacturer), and there are no data published from studies other than HIGHER and a trial of enoxaparin. A single-patient study was registered, but it was never completed. Unfractionated heparin does appear to have some promise and deserves further evaluation.

Anonymous Patient Answer

What does unfractionated heparin usually treat?

Patients with acute lung injury or acute respiratory distress syndrome can be treated with UFH and dexamethasone. However, the only studies about the use of heparin in these patients are from the Netherlands and the Swiss; more research on these patients is needed. Patients with acute kidney injury can be treated with heparin and dexamethasone; there is no high quality evidence for treatment with only the other two medications.

Anonymous Patient Answer

What is the latest research for covid-19?

The research for COVID-19 focuses on viral pathogenesis; clinical and epidemiological research; therapeutic treatment for COVID-19; and developing vaccine candidates for vaccines against this pathogen. There has been a strong emphasis in studying the effects COVID-19 has on the human body for potential treatments to be found. Other research concerning this pathogen aims to examine the impacts of the virus on the respiratory apparatus, the brain and organs as well as how they relate.

Anonymous Patient Answer

Who should consider clinical trials for covid-19?

Clinical trials evaluating therapy for the management of covid-19 could help to find a cure or a vaccine. The need for innovative research on covid-19 warrants urgent consideration and funding of further clinical trials.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for COVID-19 by sharing your contact details with the study coordinator.