CLINICAL TRIAL

Treatment for COVID-19

Recruiting · 18 - 65 · All Sexes · Tampa, FL

This study is evaluating whether a drug may help treat cold sores.

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About the trial for COVID-19

Eligible Conditions
Corona Virus Infection · COVID-19 · Coronavirus Infections

Treatment Groups

This trial involves 4 different treatments. Treatment 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.

Control Group 1
Zotatifin
DRUG
Control Group 2
Zotatifin
DRUG
Control Group 3
Placebo
DRUG
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Eligibility

This trial is for patients born any sex between 18 and 65 years old. 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:
Has provided informed consent and any authorizations required by local law;
Is a male or female patient ≥18 and <65 years of age;
Has a laboratory-documented positive test for SARS CoV 2 infection as determined by local laboratory using a standard, Food and Drug Administration (FDA)-approved viral RNA or viral antigen assay from any oral or respiratory sample collected within 48 hours of randomization;
Mild COVID-19
Positive testing by standard reverse transcriptase polymerase chain reaction (RT-PCR) assay or equivalent test;
Symptoms of mild illness with COVID-19 that could include fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, without shortness of breath or dyspnea;
No clinical signs indicative of moderate, severe, or critical severity;
Moderate COVID-19
Positive testing by standard RT-PCR assay or equivalent testing;
Symptoms of moderate illness with COVID-19, which could include any symptom of mild illness or shortness of breath with exertion;
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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: 52 days
Screening: ~3 weeks
Treatment: Varies
Reporting: 52 days
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 52 days.
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 Treatment will improve 5 primary outcomes, 5 secondary outcomes, and 7 other outcomes in patients with COVID-19. Measurement will happen over the course of 15 days.

Zotatifin plasma concentrations
15 DAYS
Concentrations at end of infusion, end of dosing interval, and on defined timepoint periods.
15 DAYS
Assessment and quantification of infectious virus
22 DAYS
Assessed by plaque-based or comparable assay
22 DAYS
Time to viral load undetectability
22 DAYS
Time to the first of 2 consecutive negative SARS-CoV-2 measurements assessed from daily samples
22 DAYS
Virus resistance
22 DAYS
According Virus Analysis Plan
22 DAYS
Proportion of patients below the limit of detection
22 DAYS
Assessed from daily saliva and anterior nasal samples
22 DAYS
Time to viral load undetectability;
22 DAYS
Defined as the time to the first of 2 consecutive negative SARS-CoV-2 measurements assessed from swab specimen
22 DAYS
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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 is treatment?

Current evidence suggests that most patients may not need to receive specific treatment. The number of days spent in hospital and the number of people who required surgical operations also varied considerably in the studies.

Anonymous Patient Answer

What are the signs of covid-19?

Fever is the most important initial finding in patients with severe disease. People with a non-obvious history or with no underlying disease should be observed for 14 days for flu symptoms, and then tested to eliminate the risk of false positives.

Anonymous Patient Answer

What are common treatments for covid-19?

A small proportion of patients will require no treatment but is unlikely to derive any benefit from antivirals. Treatment options for most patients will be similar to that recommended for other infections.

Anonymous Patient Answer

What is covid-19?

Results from a recent clinical trial confirms that a small proportion of people are affected by what appears to be a highly virulent strain of a novel coronavirus that has resulted in massive circulating and epidemic disease.

Anonymous Patient Answer

What causes covid-19?

This case illustrates the need for greater awareness of the relationship of viruses to chronic diseases and how different viruses can affect the immune system leading to different symptoms of pneumonia and possibly other systemic complications.

Anonymous Patient Answer

Can covid-19 be cured?

In a recent study, findings is the first to demonstrate that a small reduction in SARS-CoV-2 load can be achieved with anti-coronavirus monoclonal treatment. The mechanism of action of the monoclonal antibody may be associated with direct binding to SARS-CoV-2, as well as to the other SARS-CoV isolates.

Anonymous Patient Answer

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

We calculated that in the United States, more than 6,000 individuals with co-morbidities are infected each year with 1,000 being hospitalized and 3,500 dying from this disease. The overall hospitalizations and deaths due to this disease and the number of individuals infected in the US have the potential to be extraordinarily high. In order to prevent such epidemics, it will be crucial to implement measures to prevent the spread of the disease and treatment of already infected individuals in a timely fashion.

Anonymous Patient Answer

What is the latest research for covid-19?

COVID-19 and the outbreak of severe acute respiratory syndrome were two pandemics started at the same time around the world, but the reason for the spread of the virus remains unknown. After a quick outbreak of SARS (several countries, July 2003 - June 2004), Hong Kong was the last country in which SARS-like cases was reported until December 2003 (two months after Hong Kong began to be hit by the outbreak of SARS) which were diagnosed in Hong Kong patients who underwent treatment for a common cold or a flu. In these two countries, the disease was called by several different names.

Anonymous Patient Answer

Who should consider clinical trials for covid-19?

In a recent study, findings of this study indicate that, after controlling for the potential confounding covariates, age, and race in the case-fatality model, male gender is associated with a lower risk for clinical case fatality in persons with non-critical diagnoses who are admitted to the emergency department. Female gender was strongly associated with higher rates of the severe disease and, in particular, mechanical ventilation and ICU admission.

Anonymous Patient Answer

What are the latest developments in treatment for therapeutic use?

Most clinicians and patients will not be affected by therapeutics or treatments associated with potential harm. Many patients have concerns about antiviral therapies, especially for acute infections. Current guidelines and guidelines from national societies emphasize the use of non-invasive therapies. Effective non-invasive therapies will evolve; antivirals or other therapeutics aimed at chronic infections such as tuberculosis may not be necessary in the long run. There are reports of new therapeutics in development of therapeutic antiviral/antimalarial drugs to reduce the number of infections caused by viruses and malaria parasites as well as reducing mortality for patients with these infections.

Anonymous Patient Answer

Does covid-19 run in families?

In this cohort, no evidence was found that the incidence of covid-19 in young children was influenced by a parents or sibling's infection. Children with no exposure to any other infections were at significantly higher risk.

Anonymous Patient Answer

How does treatment work?

Clinically, it has been theorised that antiviral agents induce a cytopenic state, which leads to the clearance of the virus. In the context of a post-exposure immune reconstitution inflammatory syndrome (IRIS), this may cause tissue injury/damage but the benefits of treatment are likely to outweigh this risk. However, the possibility of IRIS should be considered when deciding whether to treat patients in the early stages of an infection.

Anonymous Patient Answer
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