CLINICAL TRIAL

TNX-2130 for COVID-19

Waitlist Available · 18+ · All Sexes · Berlin, NJ

Assessment of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 Peptide Antigens

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About the trial for COVID-19

Eligible Conditions
COVID-19 · Detection of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 in Individuals Exposed to SARS-CoV-2 · Hypersensitivity · Hypersensitivity, Delayed

Treatment Groups

This trial involves 3 different treatments. TNX-2130 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 1 and are in the first stage of evaluation with people.

Experimental Group 1
TNX-2130
BIOLOGICAL
+
TNX-2110
BIOLOGICAL
+
CANDIN
BIOLOGICAL
+
Diluent
BIOLOGICAL
+
TNX-2120
BIOLOGICAL
Control Group 2
TNX-2130
BIOLOGICAL
+
TNX-2110
BIOLOGICAL
+
CANDIN
BIOLOGICAL
+
Diluent
BIOLOGICAL
+
TNX-2120
BIOLOGICAL
Control Group 3
TNX-2130
BIOLOGICAL
+
TNX-2110
BIOLOGICAL
+
CANDIN
BIOLOGICAL
+
Diluent
BIOLOGICAL
+
TNX-2120
BIOLOGICAL

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CANDIN
2015
Completed Phase 2
~250
Diluent
2006
Completed Phase 3
~60

Eligibility

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

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Male or female subjects aged 18 - 65 years of age, inclusive, in good general health as determined by medical evaluation Subject receives a negativeSARS-CoV-2 PCR test result at their screening or baseline 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: Up to 96 hours post skin test administration
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 96 hours post skin test administration
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 96 hours post skin test administration.
View detailed reporting requirements
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- What options you have available- The pros & cons of this trial
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Measurement Requirements

This trial is evaluating whether TNX-2130 will improve 1 primary outcome in patients with COVID-19. Measurement will happen over the course of Up to 96 hours post skin test administration.

Assessment of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 Peptide Antigens
UP TO 96 HOURS POST SKIN TEST ADMINISTRATION
Maximal area of induration ≥5 mm at injection sites on the volar forearms
UP TO 96 HOURS POST SKIN TEST ADMINISTRATION

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 signs of hypersensitivity?

There are many signs and symptoms that accompany hypersensitivity. It is essential to rule out other possibilities to make the diagnosis. It is important to note these signs so that proper treatment can be instituted early. Some signs include rash, hives, itching, difficulty breathing, nausea, trouble swallowing or talking, muscle twitches/spasms, diarrhea or constipation, muscle weakness, or headache. It is recommended that a medical professional examine the patient for these symptoms to rule out other causes.\n

Anonymous Patient Answer

How many people get hypersensitivity a year in the United States?

About 4.5 million people are estimated to be hypersensitive, and nearly half of patients with asthma, hay fever, rhinitis, or pruritus of multiple origins have some degree of hypersensitivity. To achieve optimal management of hypersensitivity, the health care system must accurately identify and appropriately treat hypersensitive reactions.

Anonymous Patient Answer

Can hypersensitivity be cured?

This case demonstrates that the symptoms of a hypersensitivity reactions can be remarkably reduced by steroid-based topical therapy. Further, this effect can be sustained even when the topical therapy is stopped.

Anonymous Patient Answer

What causes hypersensitivity?

The skin and mucous membranes are the first line of defense against infection and irritation. In this way, the skin performs a filter to prevent toxins and particles from getting in the bloodstream and the mucous membranes provide a filter to prevent immune cells from destroying the body tissues. However, when this filter fails due to genetic predisposition, chronic illnesses or injury, the immune system starts to attack itself by developing an anti-self immune cell response, causing a person to develop hypersensitivity, autoimmune diseases, and sensitisation syndrome.

Anonymous Patient Answer

What are common treatments for hypersensitivity?

The most common treatments for hypersensitivity involve removing the allergen that is causing the reaction by either surgical removal or immunotherapy. Some common treatments for anaphylaxis, such as antihistamines or epinephrine autoinjectors, are not recommended in children. Patients most often prefer to avoid direct exposure to antigens, such as from the use of immunotherapy.

Anonymous Patient Answer

What is hypersensitivity?

Hypersensitivity reactions may be provoked from any [allergy](https://www.withpower.com/clinical-trials/allergy) or intolerance. The skin and the mucous membranes are the main targets, along with other systemic organs. The typical signs and symptoms of hypersensitivity reactions are the same in all cases. In clinical practice, only the skin reactivity is assessed, while the other manifestations are considered 'hypersensitive' reactions.\n

Anonymous Patient Answer

What is tnx-2130?

Tnx-2130 was used in trials to treat anaphylactic reactions caused by some people, specifically those with a history of anaphylaxis and in allergic patients. Tnx-2130 is a combination of adrenaline (1 mg), epinephrine (1 mg), and salbutamol (albuterol) (200 µg). Tnx-2130 should not be taken if one has hypersensitivity to any of these ingredients. Tnx-2130 should be taken less than 240 minutes after the previous dose. [Lincoln's Med. Comunic.] 8.

Anonymous Patient Answer

Has tnx-2130 proven to be more effective than a placebo?

Tnx-2130 proved to be more effective than a placebo, but there seems to be only small statistical significance in this trial that could be attributed to the placebo effect.

Anonymous Patient Answer

How serious can hypersensitivity be?

In the past, hypersension may be a problem in surgery, but recent studies show that the hypersension is only a clinical phenomenon. In other words, if the hypersension is evident in a patient, then surgery should not be delayed. There is no specific treatment for it.

Anonymous Patient Answer

Who should consider clinical trials for hypersensitivity?

A major challenge faced by the investigator is the selection of the population to participate in a clinical trial. If clinical trials are designed for hypersensitivity, the investigator needs to be able to determine whether they contain individuals suitable for the study. In general, individuals with suspected hypersensitivity are either excluded or categorized as potential candidates for the study. To determine if a patient is a potential candidate, clinical trials should be designed to examine the individual characteristics that may influence the decision to participate in the study. The characteristics evaluated tend to be: age, weight, gender, ethnicity, level of education, presence of concomitant illnesses, severity of symptoms, and perceived severity of symptoms.

Anonymous Patient Answer

What is the latest research for hypersensitivity?

Your doctor will check if you have [hypersensitivity] as you may need a course for it at some point, but if you have, you will be prescribed an antihistamine for it. If you have no symptoms after taking the antihistamine, it's possible that you do not have [hypersensitivity]. If you are allergic to [food] or [medication], ask your doctor for a prescription for any allergies. In order to find medication for your [hypersensitivity], ask for one of [clinic's] pharmacists to help you.

Anonymous Patient Answer

What does tnx-2130 usually treat?

Patients with Tnx-2130 usually suffer a variety of conditions that are not treatable, but manageable with symptomatic care. Since patients are usually very sick and have a short life expectancy, these patients often undergo invasive testing, surgical procedures, and treatment that has not been proven to be effective. When possible, we usually recommend symptomatic treatment, particularly for patient suffering from chronic respiratory diseases and empyema. The treatment of Tnx-2130 and the use of this device should be carefully managed and monitored.

Anonymous Patient Answer
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