ensovibep for COVID-19

1
Effectiveness
2
Safety
Universitair Medisch Centrum Utrecht, Utrecht, Netherlands
COVID-19
ensovibep - Drug
Eligibility
Any Age
All Sexes
Eligible conditions
COVID-19

Study Summary

This study is evaluating whether ensovibep can be used to treat COVID-19.

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether ensovibep will improve 3 primary outcomes and 35 secondary outcomes in patients with COVID-19. Measurement will happen over the course of up to day 29.

Day 8
Part A - SARS-CoV-2 viral load
Day 91
Part B - Proportion of patients with post-acute COVID-19 symptoms
up to day 29
Part A - Occurrence of hospitalizations, emergency room visits or death
Part A - Time to sustained clinical recovery
Part B - Occurrence of hospitalizations or death
Part B - Occurrence of hospitalizations, emergency room visits or death
Part B - SARS-CoV-2 viral load
Part B - Time to sustained clinical recovery
up to day 91
Part A - Ensovibep Maximum Plasma Concentration [Cmax]).
Part A - Ensovibep PK parameter - AUClast
Part A - Serious adverse events (SAEs), AEs of Special Interest (AESIs), vital signs and clinical laboratory measurements.
Part B - Effect of ensovibep, compared to placebo, on general health status
Part B - TEAEs, SAEs, AESIs, vital signs and clinical laboratory measurements
Part B - treatment-emergent ADAs (TE-ADA)
Day 91
Part A - Apparent total body clearance of the drug from plasma (CL)
Part A - Free and total ensovibep concentration in serum (mass per volume units)
Part A - Number of Participants with Laboratory Abnormalities
Part A - Observed maximum concentration (Cmax)
Part A - Serious adverse events (SAEs) and AEs of Special Interest (AESIs)
Part A - Terminal Elimination Half-Life (T½)
Part A - Terminal Elimination rate constant (λz)
Part A - The apparent volume of distribution during terminal phase associated with λz (Vz)
Part A - The area under the concentration-time curve from time zero extrapolated to infinity time (AUCinf)
Part A - The area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Part A - Time to Cmax (Tmax)
Part A - Vital Signs: Blood Pressure Systolic and Diastolic (mmHg)
Part A - Vital Signs: Body Temperature (°C)
Part A - Vital Signs: Heart Rate (bpm)
Part A - Vital Signs: Oxygen Saturation (SpO2)
Part A - Vital Signs: Respiratory Rate (breaths per minute)
Part B - Number of Participants with Laboratory Abnormalities
Part B - Proportion of patients with treatment-emergent ADAs (TE-ADA)
Part B - SAEs and AESIs
Part B - Vital Signs: Blood Pressure Systolic and Diastolic (mmHg)
Part B - Vital Signs: Body Temperature (°C)
Part B - Vital Signs: Heart Rate (bpm)
Part B - Vital Signs: Oxygen Saturation (SpO2)
Part B - Vital Signs: Respiratory Rate (breaths per minute)

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

6 Treatment Groups

Placebo
ensovibep active treatment arm 1
Placebo group

This trial requires 2001 total participants across 6 different treatment groups

This trial involves 6 different treatments. Ensovibep 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.

ensovibep active treatment arm 1
Drug
Phase 2 / Part A: ensovibep active treatment arm 1
ensovibep
Drug
Phase 3/ Part B: ensovibep active treatment
ensovibep active treatment arm 3
Drug
Phase 2 / Part A: ensovibep active treatment arm 3
ensovibep active treatment arm 2
Drug
Phase 2 / Part A: ensovibep active treatment arm 2
Placebo
Drug
Phase 2 / Part A: Placebo
Placebo Comparator
Drug
Phase 3/ Part B: Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ensovibep
2021
Completed Phase 2
~20

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 8 days (days 0, 3, 5 and 8)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 8 days (days 0, 3, 5 and 8) for reporting.

Closest Location

BioPharma Clinc site - Houston, TX

Eligibility Criteria

This trial is for patients born any sex of any age. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Males or females ≥ 18 years of age on the day of inclusion (no upper limit).
You have two or more COVID-19 symptoms and onset within 7 days prior to dosing. show original
Positive test for SARS-CoV-2 in upper respiratory swab on the day of dosing (rapid antigen test).
You understand the study procedures and agree to comply with them. show original
The patient or legally authorized representative gives signed informed consent.
Part A

Patient Q&A Section

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

Does ensovibep improve quality of life for those with covid-19?

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Ensovibep may be a useful therapeutical option for the treatment of CVD-19 patients, and improved symptoms after 12 weeks of receiving it (increased SF-12 and ICSI-12 scores and lowered VAS scores) were demonstrated.

Unverified Answer

What are the signs of covid-19?

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This may include respiratory symptoms, weight loss, and fatigue. Symptoms may be similar to other, common conditions, therefore, a definitive diagnosis should only be made by the provision of a diagnosis and investigation of the individual’s history. This information may reassure patients and families in addition to providing support to staff and staff in contact with them. theme:

health care question: Is the use of dental sealants in children : more, better, and longer? answer: To achieve the oral health targets recommended by the World Health Organization and the American Dental Association, more, better, and longer oral health education programs are recommended for teachers, parents, and dental team members.

Unverified Answer

What are common treatments for covid-19?

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To date, data regarding the severity of SARS and MERS and whether potential vaccines exist for these viruses is relatively limited. In general, treatment for both SARS and MERS is supportive in nature and involves maintaining optimal nutrition, correcting electrolyte disorders and ensuring ventilation support is as stable as possible in critically sick patients. Early empiric antiviral therapy with lopinavir/ritonavir or interferon-alpha is considered the standard of care for SARS-related disease. Current evidence suggests antiviral medications should not be used in the early stages of treatment for SARS-related illness because of risk of further illness.

Unverified Answer

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

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The number of Americans who receive the coronavirus illness is expected to rise over the coming months and years. The most likely peak is during April and May of 2020. However, there is considerable variability in disease incidence and transmission throughout the country, with considerable uncertainty in determining how much will be seen overall.

Unverified Answer

What is covid-19?

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The virus SARS-CoV-2 and its mutation can enter the human body through the respiratory tract. After entry, it destroys lung tissue, causing multiple other complications throughout a person's life. Although there is no current cure, there are a few ways to minimize the risk of getting a virus like SARS-CoV-2 after being exposed.

Unverified Answer

What causes covid-19?

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Different factors related to the virus (individual, environment, and population) may lead to a wide range of symptoms. In addition, because this virus is a novel coronavirus strain, it can be difficult to predict its ability to infect humans.

Unverified Answer

Can covid-19 be cured?

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There is no cure for infections in human beings. The infection can only be overcome by recovery. Only the host can cure themselves. People with coronavirus infection will have their virus in the body only when they recover their immune systems. A cure for coronavirus maybe an illusion. The virus is not a disease like influenza, it takes time for the body to recover. The virus is not a vaccination it is a disease that should be treated. A cure for infection like Ebola infection will not come any time soon...

Unverified Answer

What are the latest developments in ensovibep for therapeutic use?

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Ensovibep(1) is a promising and novel synthetic analogue of the naturally occurring chemokine, thrombospondin-1 (TSP-1) with antiviral, anti-inflammatory and wound repair actions. It has a more favourable safety profile in comparison to other therapeutics investigated so far. The first results of an initial clinical trial are encouraging. Results will be presented at the International Conference on Antithrombotic & Thrombolytic Therapy (ATTA) in September 2019.

Unverified Answer

What are the common side effects of ensovibep?

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Ensovibep treatment induced a wide range of cutaneous, gastrointestinal and pulmonary findings. In a recent study, findings provides the most important data so far about the side effects of Ensovibep at clinical dosage in humans, thus contributing significant improvements in the care of patients treated with this antifibrotic agent.

Unverified Answer

What is the average age someone gets covid-19?

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There has been much discussion around the average age someone contracts (misdiagnosis of) covid-19, but it is important to consider the disease is highly variable and highly contagious. This article highlights the average age of symptomatic patients with which the public must be informed before embarking on a self-immunisation initiative and how the average age of symptomatic patients differs across a range of health services. There is no single 'average' for this disease; we must be aware of this.

Unverified Answer

Is ensovibep typically used in combination with any other treatments?

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As more data become available, it will become easier to determine the most appropriate treatment for ENSOVABEP-based treatment. The current experience suggests that ensovibep may be an important first-line treatment for most indications unless stated otherwise.

Unverified Answer

Has ensovibep proven to be more effective than a placebo?

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Ensovibep is well tolerated in this clinical trial in both adult and pediatric patients over a period of 10 weeks and provides rapid and sustained improvements in both pain and disease activity parameters, especially reductions in patient assessments of disability over baseline.

Unverified Answer
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