CLINICAL TRIAL

APN01 for COVID-19

Recruiting · 18+ · All Sexes · Houston, TX

This study is evaluating whether a treatment that modulates the host tissue response can improve clinical outcomes in patients with COVID-19.

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About the trial for COVID-19

Eligible Conditions
Coronavirus Infection · Infections · Communicable Diseases · COVID-19 · Coronavirus Infections · Coronavirus Disease 2019 (COVID‑19)

Treatment Groups

This trial involves 5 different treatments. APN01 is the primary treatment being studied. Participants will be divided into 4 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

Experimental Group 1
APN01
DRUG
Experimental Group 2
Fostamatinib
DRUG
Experimental Group 3
TRV027
DRUG
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About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Angiotensin 1-7
Not yet FDA approved
TRV027
2020
Completed Early Phase 1
~30
Fostamatinib
FDA approved
Alunacedase alfa
Not yet FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Hospitalized for COVID-19
You are 18 years of age or older. show original
a nucleic acid test (NAT) or equivalent testing within 3 days prior to randomization OR documented by NAT or equivalent testing more than 3 days prior to randomization AND progressive disease suggestive of ongoing SARS-CoV-2 infection per the responsible investigator (For non-NAT tests, only those deemed with equivalent specificity to NAT by the protocol team will be allowed. A central list of allowed non- NAT tests is maintained in in the study protocol)
Hypoxemia, defined as SpO2 <92% on room air, new receipt of supplemental oxygen to maintain SpO2 ≥92%, or increased supplemental oxygen to maintain SpO2 ≥92% for a patient on chronic oxygen therapy
cough
You have a temperature of 100.4 degrees Fahrenheit or greater.\n show original
You have shortness of breath. show original
chest painTXA127-specific exclusion criter
A chest x-ray, CT scan, or lung ultrasound demonstrates pulmonary infiltrates. show original
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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: Day 1 to hospital discharge or Day 90 whichever comes first
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Day 1 to hospital discharge or Day 90 whichever comes first.
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 APN01 will improve 1 primary outcome, 16 secondary outcomes, and 16 other outcomes in patients with COVID-19. Measurement will happen over the course of Day 0 to Day 5 or hospital discharge whichever comes first.

Incident renal replacement therapy during hospitalization
DAY 0 TO DAY 5 OR HOSPITAL DISCHARGE WHICHEVER COMES FIRST
Proportion of participants requiring renal replacement therapy
RAAS pathway mechanistic biomarkers
DAY 0 TO DAY 5 OR HOSPITAL DISCHARGE WHICHEVER COMES FIRST
Proportion of participants with changes in RAAS mechanistic biomarkers (AngII, Ang(1-7), ACE activity and ACE2 activity) before, during and after therapy during hospitalization.
Changes in NT-proBNP (pending funding)
DAY 0 TO DAY 5 OR HOSPITAL DISCHARGE WHICHEVER COMES FIRST
Proportion of participants with changes in NTproBNP before, during and after therapy during hospitalization.
Allergic reaction
DAY 0 TO DAY 5 OR HOSPITAL DISCHARGE WHICHEVER COMES FIRST
Proportion of participants with allergic reaction, including rash and angioedema
Hypotension
DAY 0 TO DAY 5 OR HOSPITAL DISCHARGE WHICHEVER COMES FIRST
Proportion of participants with hypotension defined by low arterial blood pressure leading to either [1] initiation or increase in vasopressor therapy, [2] administration of a fluid bolus of 500 ml or more, or [3] modification of the dose or discontinuation of the study drug.
Myocardial injury
DAY 0 TO DAY 5 OR HOSPITAL DISCHARGE WHICHEVER COMES FIRST
Proportion of participants with Myocardial injury described by changes in troponin before, during and after therapy during hospitalization.
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Who is running the study

Principal Investigator
S. C.
Prof. Sean Collins, Professor, Emergency Medicine
Vanderbilt University Medical Center

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 common treatments for covid-19?

Covid-19 is predominantly treated by supportive measures including symptom management, anti-infection, anti-inflammation, oxygen therapy, anti-depressant medications, fluid or electrolyte replacement, bed rest, and treatment for associated co-morbidities. There is a need to develop targeted treatments against this virus as a significant number of patients in hospitals require treatment.

Anonymous Patient Answer

Can covid-19 be cured?

The current state of knowledge of the disease is still rather limited, and the effects from the vaccination are as yet unknown. Nevertheless, several groups are currently conducting clinical trials.

Anonymous Patient Answer

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

The data suggest a significant increase in the number of people infected with SARS-CoV-2 in the US, with a more recent increase in the rate of cases, and a large percentage of them were hospitalized in the first 9 weeks of their infection.

Anonymous Patient Answer

What is covid-19?

This article presents for the first time a review of available evidence regarding the epidemiology (including the clinical course and outcome) and the management of COVID-19 patients. The available evidence on COVID-19 suggests a high-fatality rate (i.e. >50%), particularly among elderly patients. It also suggests the possibility of a prolonged and more severe clinical manifestation of COVID-19 among the young and fit, which may affect the general public health policy.

Anonymous Patient Answer

What are the signs of covid-19?

Signs are often nonspecific. On imaging, the early stages of the disease may resemble the common flu, which may make the diagnosis of the virus difficult or even missed. In the last 4 months, several publications described the clinical manifestations of the disease and, consequently, of the image findings. In addition, the most recent reports suggest that the disease may occur at lower rates, potentially making it underdiagnosed. On the other hand, imaging may not always be able to detect the early stages of the disease, hence the importance of clinical assessment.

Anonymous Patient Answer

What causes covid-19?

Although various studies are currently being conducted to understand the cause of COVID-19, no clear conclusion can be drawn regarding its cause due to the lack of a definite conclusion. Currently it is assumed that the SARS virus of 2003 and 2019 has originated from bats. At present it is assumed that the SARS and COVID-19 viruses are different from one another but share one basic ancestor.

Anonymous Patient Answer

Have there been other clinical trials involving apn01?

We found several trials that involved apn01. At least one clinical trial was conducted using apn01 on a national or global population, with a high risk for SARS and influenza outbreaks. In all, these trials were not necessarily blinded; however, some used double arms. In contrast, one study using single-arm design was blinded, but had a small enrollment. There were one trial with apn01 using a double blind, but the clinical trial was halted early; therefore, no conclusions regarding efficacy could be drawn. Although there are no conclusions to be draw from a single study, given this information, we believe that the apn01 treatment regimen does appear to have potential therapeutic value.

Anonymous Patient Answer

What are the latest developments in apn01 for therapeutic use?

apn01 is a potential antiviral candidate for COVID-19. The study is based on the data from the first phase I human immunotransplant (HIT) clinical evaluation of apn01. More clinical studies to evaluate the effects on the clinical course of COVID-19 are necessary before any regulatory agency can consider apn01 for clinical evaluation. summary: This research study is examining whether an antiviral drug may be useful in the treatment of COVID-19.

Anonymous Patient Answer

How does apn01 work?

The mechanism by which [apn01] improves patient outcomes is still being studied. It appears to cause the body's immune system to attack and destroy infected cells [apn01] which would hinder the infectious spread of pneumonia.

Anonymous Patient Answer

What is apn01?

To evaluate whether apn01 might have a role in the pathogenesis of COVID-19 in human beings, we conducted a case-control study. In a recent study, findings of this study suggest that plasma apn01 levels might serve as a biomarker for COVID-19 infections.

Anonymous Patient Answer

Who should consider clinical trials for covid-19?

Current guidelines advise healthcare professionals to restrict clinical trial participation for patients with severe infection and/or acute lung involvement to those with high likelihood and high urgency for trial participation. This is not always the case however. In the setting of a community outbreak, the risk-to-benefit ratio cannot be assessed retrospectively and guidelines to restrict clinical trial participation are probably too restrictive. Clinical trials are urgently needed to reduce mortality in patients with severe infection and/or acute lung involvement. Oncovid-19 cases are likely to skew the sample toward the most serious cases (those with ICU admission and/or severe respiratory failure). If more clinical trials are performed, these cases will represent a smaller fraction of the whole population of people with ICU admission.

Anonymous Patient Answer

What are the common side effects of apn01?

Apn01, a subgroup of antiviral drugs currently used to treat coronavirus infections in China, has an excellent safety and tolerability profile with few common adverse effects.

Anonymous Patient Answer
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