Pfizer-BioNTech COVID-19 Vaccine for COVID-19

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University Health Network, Toronto, Canada
COVID-19+3 More
Pfizer-BioNTech COVID-19 Vaccine - Biological
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new vaccine might help people with chronic kidney disease and dialysis to respond to a COVID-19 vaccine.

See full description

Eligible Conditions

  • COVID-19
  • Chronic Kidney Disease (CKD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Pfizer-BioNTech COVID-19 Vaccine will improve 1 primary outcome and 7 secondary outcomes in patients with COVID-19. Measurement will happen over the course of 12 months.

1 months
Number of mononuclear cells in peripheral blood (PBMC)
Proportion of B and T-cell lymphocyte subsets in peripheral blood mononuclear cells (PBMC) in a subset of participants
12 months
Death
Hospitalization
Number of patients with COVID-19 infections
Serum Level of SARS-CoV-2 Antibodies (Spike, RBD-Receptor Binding Domain, NP- nucleocapsid protein)
One month
Serum Level of Anti-RBD ( Anti Receptor Binding Domain )
one month
Adverse Event

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

4 Treatment Groups

Patients who received two doses MODERNA vaccine, Arm 2
1 of 4
Patients who received two doses Pfizer-BioNTech vaccine ,Arm 3
1 of 4
Patients who received two doses Pfizer-BioNTech vaccine, Arm 1
1 of 4
Patients who received two doses MODERNA vaccine, Arm 4
1 of 4
Experimental Treatment

This trial requires 268 total participants across 4 different treatment groups

This trial involves 4 different treatments. Pfizer-BioNTech COVID-19 Vaccine is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

Patients who received two doses MODERNA vaccine, Arm 2
Biological
Patients who received two doses Pfizer-BioNTech vaccine ,Arm 3
Biological
Patients who received two doses Pfizer-BioNTech vaccine, Arm 1
Biological
Patients who received two doses MODERNA vaccine, Arm 4
Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pfizer-BioNTech COVID-19 Vaccine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 months for reporting.

Closest Location

University Health Network - Toronto, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients with Chronic Kidney Disease (CKD) who have an eGFR of less than 45ml/min/1.73m2 will be eligible show original
The study enrolment is open to anyone over the age of 18. show original

Patient Q&A Section

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

"In the United States, the annual incidence rate for symptomatic infections with SARS-CoV infection and virus RNA detected in whole-blood (i.e., SARS-CoV RNA in RT-qPCR samples of whole blood specimens) has been about 0.35% during the period 2000-2018 (n = 5,919), with higher levels for the period 2012-2017 (0.37%, n = 4,051) and very low levels (less than zero) for the periods 1990-1996 (0.08%, n = 148) and 1976-1986 (0.19%, n = 21)." - Anonymous Online Contributor

Unverified Answer

What are common treatments for covid-19?

"Generally, non-steroidal anti–inflammatory drugs (NSAIDs) and antiviral drugs are the most popular form of medicine in the disease, but there are certain limitations and it is important to use the drug at the onset of symptoms in order to reduce the spread and number of spread in the body. In people with serious illness especially the disease can also spread very rapidly from one patient to another in real life. From one patient to another, one needs to be cautious during and after the process of recovery. There is a recommendation for the use of oseltamivir and the latest vaccine (COVID-19 vaccine) is not effective or available in the country." - Anonymous Online Contributor

Unverified Answer

What are the signs of covid-19?

"Fever of >38.3 degrees Celsius, headache, muscle aches, dry cough and fatigue are the main symptoms and should be considered in people who are exposed to" - Anonymous Online Contributor

Unverified Answer

Can covid-19 be cured?

"It is impossible to cure Covid-19. Current treatment may slow the spread of infection but is not sufficient to eradicate it completely. The virus continues to circulate, even when the general population remains asymptomatic. The majority of people affected are mildly ill and recover within a short period after developing symptoms. Although some people with severe symptoms or complications may require hospitalisation, the benefits of the intervention generally appear to be small and the risk very high." - Anonymous Online Contributor

Unverified Answer

What is covid-19?

"Covid-19 is a viral infection arising from the coronaviruses and spreads easily from person to person through droplets and fomites; it typically evolves from asymptomatic or mild disease into an acute respiratory illness, possibly severe, with systemic symptoms and a fever, and then progresses into pneumonia, which is often severe, especially in the elderly. The severity and extent of disease can vary between individuals. The severity of disease is related to the individual’s underlying medical condition, viral genetics and immune status. People infected with coronavirus have a different immune profile to those with other infections and those with no other illness, and this may influence how serious and how long the coronavirus will remain in the body." - Anonymous Online Contributor

Unverified Answer

What causes covid-19?

"It is important to note that the above parameters, including viral loads and treatment durations, are not stable or stable only with respect to the current outbreak. The reasons why they can or cannot be stable are still unclear. Some of them could be related to interactions of the virus with the host factors, while some could be related to the genetic polymorphisms of the hosts and their reactions to the virus. It is crucial to understand that the virus itself may or may not be the root cause of the disease, as the virus might simply be a coincidence." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of covid-19?

"In terms of human to animal transmission of SARS, research from the United States suggests the SARS virus was unlikely transmitted to humans directly from its natural reservoir of civets. Instead, the SARS virus likely spread to humans from an intermediate host species like bats. Although the evidence suggests some humans caught SARS from the bats, the researchers found no evidence of the SARS virus in humans more than a year after the initial SARS outbreak in South East Asia. As a result, the researchers concluded that it unlikely humans caught SARS from bats." - Anonymous Online Contributor

Unverified Answer

Does covid-19 run in families?

"Based on limited retrospective data from a pediatric practice, in a real world situation it is difficult to determine if the prevalence of a mutation is increased in people with a positive family history of the condition." - Anonymous Online Contributor

Unverified Answer

Is pfizer-biontech covid-19 vaccine safe for people?

"Results from a recent clinical trial indicate the safety of the PBO/IPV/MF59-biontech V520 and the PBO/MF59-biontech V520 formulations, regardless of immunization schedule for individuals receiving treatment with antiviral drugs to prevent infection by MERS-CoV in the setting of an MERS outbreak. A prospective randomized study is needed to evaluate safety of PBO V520 and IPV formulation vaccine in other cohorts and in individuals at increased risk for infection. A study to validate these results in a larger population is also warranted." - Anonymous Online Contributor

Unverified Answer

What is the latest research for covid-19?

"While no cure can be found for covid-19, scientists want to find [a cure], because [if] you don't, the virus that causes it will be here, and then you've got a lot to worry about [other than] covid-19"

"Miconia cuspidata\n\nMiconia cuspidata is a species of plant in the family Melastomataceae." - Anonymous Online Contributor

Unverified Answer

Does pfizer-biontech covid-19 vaccine improve quality of life for those with covid-19?

"The P-Bio BIVENZ(TM) H5N1 aVax1.3 vaccine was well tolerable and immunogenic, was well received by trial participants who reported higher QOL scores during follow-up. QOL is an important outcome metric for patients with confirmed H1N1/09 infection, especially those who were exposed to influenza or H5N1 and are medically stabilized. Copyright © 2016 John Wiley & Sons, Ltd." - Anonymous Online Contributor

Unverified Answer

How serious can covid-19 be?

"Patients presenting with CVHD symptoms could present with an increased need for care in the community. Clinicians will need to identify and address medical comorbidities in patients with CVHD. In a global health emergency, CVHD could be one of the earliest clinical manifestations of a severe disease affecting millions of people." - Anonymous Online Contributor

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