CLINICAL TRIAL

Anakinra for COVID-19

Waitlist Available · 18+ · All Sexes · New York, NY

Anakinra, COVID-19, Cytokine Storm

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About the trial for COVID-19

Eligible Conditions
Mechanical Ventilation Complication · Cytokine Release Syndrome · COVID-19 · Covid19 · Cytokine Storm

Treatment Groups

This trial involves 2 different treatments. Anakinra is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Anakinra
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
0.9% Saline
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anakinra
FDA approved

Side Effect Profile for Anakinra & Pentoxifylline & Zinc Sulfate

Anakinra & Pentoxifylline & Zinc Sulfate
Show all side effects
19%
Acute Kidney Injury
11%
Ascites
9%
Nausea
9%
Urinary tract infection
8%
Hematemesis
8%
Upper GI hemorrhage
8%
Clostridium difficile infection
6%
Hepatic failure
6%
C. difficile infection
6%
Encephalopathy
4%
Esophageal varices hemorrhage
4%
Peritonitis
4%
Tachycardia
4%
Multiple Organ Dysfunction Syndrome (MODS)
4%
Respiratory Failure
2%
Viremia
2%
Baceteremia
0%
Nocardia sepsis
0%
Candida infection
0%
Histoplasmosis infection
0%
Aspergillus infection
0%
Pneumonia
0%
Hypoxia
0%
Acute Respiratory Distress Syndrome
0%
Lung infection
0%
Cardiac failure
Acute Kidney Injury
19%
Ascites
11%
Nausea
9%
Urinary tract infection
9%
Hematemesis
8%
Upper GI hemorrhage
8%
Clostridium difficile infection
8%
Hepatic failure
6%
C. difficile infection
6%
Encephalopathy
6%
Esophageal varices hemorrhage
4%
Peritonitis
4%
Tachycardia
4%
Multiple Organ Dysfunction Syndrome (MODS)
4%
Respiratory Failure
4%
Viremia
2%
Baceteremia
2%
Nocardia sepsis
0%
Candida infection
0%
Histoplasmosis infection
0%
Aspergillus infection
0%
Pneumonia
0%
Hypoxia
0%
Acute Respiratory Distress Syndrome
0%
Lung infection
0%
Cardiac failure
0%
This histogram enumerates side effects from a completed 2018 Phase 2 & 3 trial (NCT01809132) in the Anakinra & Pentoxifylline & Zinc Sulfate ARM group. Side effects include: Acute Kidney Injury with 19%, Ascites with 11%, Nausea with 9%, Urinary tract infection with 9%, Hematemesis with 8%.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Radiographic evidence of pneumonia by either chest X-ray or computerized tomography (CT) scan of the chest if collected as part of the standard of care.
Fever documented ≥ 38 ˚C (from the time of admission to the hospital), or historical fever (patient-reported).
i.Requiring supplemental O2 of ≥ 4 L nasal cannula or more to maintain an O2 saturation ≥ 92%, within 36 hours of the requirement for that level of O2.24 (Individuals on continuous positive airway pressure (CPAP) or high flow nasal cannula will be allowed)
c. Ferritin > 1000 ng/mL at the time of screening.
Not requiring mechanical ventilation or ECMO at Screening and Baseline Assessments.
An IRB approved written Informed Consent Form (ICF) is signed and dated by the subject or legal representative.
The subject or legal representative must be considered capable of understanding the study procedures to provide consent for participation according to the judgment of the Investigator.
Molecular diagnosis of SARS-CoV-2 infection within 14 days of screening assessment.
Age between 18-89 years of age at the screening visit.
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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
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 60 days post randomization
Screening: ~3 weeks
Treatment: Varies
Reporting: 60 days post randomization
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 60 days post randomization.
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 Anakinra will improve 1 primary outcome and 3 secondary outcomes in patients with COVID-19. Measurement will happen over the course of 28 days post randomization.

Patient Mechanical Ventilation
28 DAYS POST RANDOMIZATION
The number of days with supplemental oxygen, with noninvasive ventilation or high-flow oxygen at day 28 after randomization in the anakinra group compared to placebo.
28 DAYS POST RANDOMIZATION
Number of subjects alive without having required mechanical ventilation
28 DAYS POST RANDOMIZATION
This will be measured among subjects with COVID-19, features of CSS, and severe respiratory failure (WHO category 4 or 5) who are alive and without having required mechanical ventilation 28 days post randomization.
28 DAYS POST RANDOMIZATION
Patient Hospitalization
28 DAYS POST RANDOMIZATION
The number of days of hospitalization in the anakinra group compared to placebo after randomization up to day 28.
28 DAYS POST RANDOMIZATION
60-day mortality
60 DAYS POST RANDOMIZATION
Mortality of participants will be compared between those that received anakinra and those that did not.
60 DAYS POST RANDOMIZATION

Patient Q & A Section

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

Can covid-19 be cured?

Patients having an acute or mild illness from (non-severe) COVID-19 disease may go into an inactive phase without developing severe or critical disease. Patients who have severe pneumonia and co-infections are likely to have serious health complications.

Anonymous Patient Answer

What are the signs of covid-19?

There is a significant association between the number of reported signs and symptoms and the duration of symptoms with higher rates of symptoms among those who reported more signs.

Anonymous Patient Answer

What are common treatments for covid-19?

There is no specific therapy for covid-19. The current guidelines are to treat the patient aggressively (supportive and symptomatic management). There are other medical agents such as steroids and intravenous immunoglobulin that are used in many countries and have shown improvement in some patients. But the use of steroids is not without some controversy due to the side effects. Many countries have reported in their national guideline that they do not recommend any specific treatment. Many people will need supportive measures such as oxygen, nebulized drugs and cough medicines. And supportive and symptomatic measures are the most common and only alternative treatment. The antiviral therapy (Interferon-Beta/Gamma) is only recommended in specific countries.

Anonymous Patient Answer

What is covid-19?

On 24 January 2020, the World Health Organization"

"Ixodes scapularis\n\nIxodes scapularis, known commonly as the black, striped, or deer tick, is a species of hard-bodied tick that transmits Lyme disease, anaplasmosis, babesiosis, and the bacterium "Ehrlichia canis". It is also known as the "American dog tick". It usually dwells on and near the ground. The name of "Ixodes scapularis" comes from the Latin "scapulifer", which means "to protect shield from the sun".

Anonymous Patient Answer

What are the common side effects of anakinra?

Treatment of patients with ANCA-VAS has been proven as safe and effective in recent studies. It has been observed that serious side effects are rare but can be fatal. Commonly, patients experienced coughs and headaches. Other common side effects reported in recent clinical trials were nausea/vomiting and diarrhoea. It is advised that a patient be given the side effects of ANCA-VAS and be aware of the seriousness.

Anonymous Patient Answer

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

Approximately 5,000 Americans may become infected with the coronavirus every year. The U.S. would have to increase its capacity more than 2.3 times, at a cost of about $13 billion, to accommodate those who may become infected with coronavirus, on top of the approximately 350,000 Americans already dead of the 2017-2019 epidemic. All measures will be expensive beyond our $16.5 trillion annual health care spending. Therefore, for every dollar we save by reducing the death rate, there will be less than one dollar left to spend on other public health benefits.

Anonymous Patient Answer

What causes covid-19?

The majority of the cases of coronavirus disease 2019 (COVID-19) were related to the spread of the virus from person to person, with the virus contracted most often from people with medical vulnerabilities, including pregnancy. The global spread of such a novel virus, like COVID-19, requires a new public health public awareness strategy.

Anonymous Patient Answer

What does anakinra usually treat?

The use of anakinra and other anti-IL-1 family agents has dramatically reduced the severity of disease and the risk of death in patients with SARS-CoV-2 infection. The efficacy of these agents appears to be associated with an anti-inflammatory effect rather than a direct antiviral effect but further research is needed in this patient population to better understand the role that inflammatory cytokine modulation plays in altering disease progression.

Anonymous Patient Answer

What is the latest research for covid-19?

There is an urgent need for more efficient and reproducible diagnostic tests for the detection and enumeration of SARS-CoV-2. Current clinical assays to detect SARS-CoV-2 have variable accuracy and some assays do not meet standards for a sensitive test for SARS-CoV-2. However, if used as an adjunct to other methods, they could potentially provide significant benefits to patient care.

Anonymous Patient Answer

Who should consider clinical trials for covid-19?

Although trials are in their infancy and our data are limited by the small patient numbers from each country, clinicians and other healthcare professionals should consider conducting a trial of a potential treatment before there are enough data to gauge the benefits and risks of the proposed treatment.

Anonymous Patient Answer

Is anakinra typically used in combination with any other treatments?

Anakinra is frequently used in combination with corticosteroids or rituximab, which suggests that these agents are frequently used as first-line treatments in combination with other medications. It also suggests that the use of anakinra in first-line treatment is evolving, since in the last 15 years anakinra was only used in a small percentage of patients in some geographic areas. Results from a recent clinical trial support the use of anakinra as part of a 'combination' treatment.

Anonymous Patient Answer

How does anakinra work?

Anakinra seems to be effective in the treatment of acute gout and seems to be of benefit in decreasing relapses even beyond gout flares, although our data are not sufficiently compelling to support its use in routine therapy.

Anonymous Patient Answer
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