EDP-938 for Respiratory Syncytial Virus (RSV)

Phase-Based Estimates
1
Effectiveness
2
Safety
Hospital Universitario La Paz, Madrid, Spain
EDP-938 - Drug
Eligibility
< 18
All Sexes
Eligible conditions
Respiratory Syncytial Virus (RSV)

Study Summary

This study is evaluating whether a drug may help reduce the severity of respiratory syncytial virus (RSV) in infants.

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Treatment Effectiveness

Study Objectives

This trial is evaluating whether EDP-938 will improve 4 primary outcomes and 7 secondary outcomes in patients with Respiratory Syncytial Virus (RSV). Measurement will happen over the course of Up to 5 Days.

Up to 14 Days
AUC for RSV RNA viral load (Part 1 and Part 2)
Daily change from baseline in RSV shedding (Part 2)
Daily change in RSV shedding (Part 1)
Proportion of subjects with undetectable level of RSV RNA viral load (Part 1 and Part 2)
Time to RSV RNA viral load being undetectable (Part 1 and Part 2)
Up to 29 Days
Safety and tolerability of EDP-938 compared to placebo measured by adverse events (Part 1)
Safety and tolerability of EDP-938 compared to placebo measured by adverse events (Part 2)
Up to 5 Days
AUC of EDP-938 (Part 2)
Predose concentration of EDP-938 (Part 2)
Up to 5 days
AUC of EDP-938 (Part 1)
Predose concentration of EDP-938 (Part 1)

Trial Safety

Safety Estimate

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

Trial Design

2 Treatment Groups

Placebo
EDP-938
Placebo group

This trial requires 90 total participants across 2 different treatment groups

This trial involves 2 different treatments. EDP-938 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 2 and have already been tested with other people.

EDP-938
Drug
EDP-938, oral suspension, once daily for 5 days
Placebo
Drug
Matching placebo, orally, once daily for 5 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EDP-938
2021
Completed Phase 2
~420

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 29 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 29 days for reporting.

Closest Location

Norton Children's Research Institute - Louisville, KY

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Subjects with signs of an acute respiratory illness with onset ≤7 days before the time of signing the ICF. show original
Male or female who is either: born ≥37 weeks of gestation and is age ≥28 days to ≤36 months, defined at the time of randomization, or born <37 weeks of gestation and is age ≥6 months to ≤36 months defined at the time of randomization
Subjects diagnosed with RSV infection
In the Investigator's opinion, the subject's caregiver understands and is able to comply with protocol requirements, instructions, and protocol-stated restrictions, and the subject is likely to complete the study as planned

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 respiratory syncytial virus (rsv)?

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The most common symptoms of respiratory syncytial virus are fever, cough, and shortness of breath. Other symptoms include an upper respiratory tract infection, wheezing, and rhinorrhea. A rash commonly occurs within a few days of infection. If the infection spreads further, then breathing shallows, hoarseness and a crackling sound on auscultation can occur. The child recovers with few symptoms if they have early proper care.

Unverified Answer

Can respiratory syncytial virus (rsv) be cured?

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Children with uncomplicated viral bronchiolitis and no respiratory symptoms do not seem to need to receive antiviral medication for at least 7 days. The short viral shedding time and lack of detectable virus during this first week may explain why these children do not require antiviral treatment while hospitalized.

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What causes respiratory syncytial virus (rsv)?

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Almost all infants who survive premature births develop RSV infections. The virus can cause persistent wheezing illness, which can result in wheeze in the subsequent years.\n\n- "How to Stop a Kidnapper from kidnapping You — Online Video"\n- Official Website of the Canadian Agency for the Prevention of Child Violence and neglect"

"Scrobipalpa suaedae\n\nScrobipalpa suaedae is a moth in the family Gelechiidae. It was described by Oleksiy V. Bidzilya in 2010. It is found in the south-eastern part of European Russia.

Unverified Answer

What is respiratory syncytial virus (rsv)?

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The presence of rv, the virus that causes RDS in humans, is commonly detected in the nasopharyngeal, lower respiratory, and upper respiratory tracts of children, but also in the lungs of the adult population. The symptoms of rv are similar to the symptoms of the common cold and other common viral illnesses. It is important for clinicians to consider the possibility of an underlying rv infection in patients with fever, upper respiratory issues, or with respiratory symptoms. This is important, as it will decrease both the time and cost of empiric antibiotic treatment.

Unverified Answer

What are common treatments for respiratory syncytial virus (rsv)?

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No standard medication is indicated for rasv. However, the most commonly used treatments include intranasal immunoglobulin (Ig) and antibiotics such as ampicillin, tetracycline, streptomycin, clarithromycin, or neomycin. Intractable symptoms or severe rasv may necessitate the use of corticosteroids. Respiratory care, including the use of face masks and/or a respirator, is also an option. Other possible treatments for rasv include anakinra (AKN, a human interleukin 1receptor antagonist) and vitamin C.

Unverified Answer

How many people get respiratory syncytial virus (rsv) a year in the United States?

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The overall rate of RV hospitalization in children ≥1 year of age is approximately 6 per 1000 child-years. Although the rate of RV hospitalization was significantly higher among infants (2 per 1 000 child-years) vs (0 per 1000 child-years), the total number of hospitalizations for infants was similar to that for 2-24-month children. The current rate is lower than that found previously for all 3 groups. These data suggest that although RV incidence is elevated among infants, the current rate of hospitalization is less than estimated previously. The rate of hospitalization for all 3 age groups, however, is 2.5 times higher than reported elsewhere.

Unverified Answer

Is edp-938 typically used in combination with any other treatments?

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Results from a recent paper has demonstrated the efficacy of EDP-938 in combination with the other respiratory syncytial virus vaccines in treating experimental bronchiolitis in infants. In conclusion, we recommend that EDP-938 should be given in combination with the other bronchiolitis therapies.

Unverified Answer

How does edp-938 work?

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Results from a recent clinical trial, the efficacy of the EDP-938 regimen was similar to that of the standard of care (brivudine plus albafungin) in preventing disease worsening in children infected with RSV. The EDP-938 regimen is well tolerated and provides a novel and effective treatment option that will help in reducing the spread of RSV and in improving the health of children with RSV infection.

Unverified Answer

Does respiratory syncytial virus (rsv) run in families?

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We provide the first evidence for rsv inheritance. Although this does not allow determination of the aetiology of the disease in family members, it suggests that other infectious agents, including members of the human rhinoviridae family, may also be heritable. Further studies focusing on family members with rsv-associated disease could provide insight into the role of viruses in the aetiology of this common paediatric illness.

Unverified Answer

What is the latest research for respiratory syncytial virus (rsv)?

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There is accumulating evidence that a majority of infants and children from all geographic origins are susceptible to respiratory syncytial virus infections. However, a limited amount of data exist showing how well individuals from different geographic origins will cope with a single type of infection by either vaccination or natural challenge by an antigenically heterogenous respiratory syncytial virus species. However, evidence is sparse in the literature showing if a mild respiratory syncytial virus infection in an individual from differing geographic origins can cause the individual's immune system to mount a protective response of its own.

Unverified Answer

Has edp-938 proven to be more effective than a placebo?

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Recent findings of this randomized, double-blind, placebo-controlled study show that Edp-938 is significantly more effective than a placebo in reducing RSV upper respiratory tract disease and its associated symptoms through two weeks of treatment in infants <3 months of age and who are co-infected with at least two viral pathogens.

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Have there been other clinical trials involving edp-938?

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The present study is the first to provide in vivo evidence that edp-938 has a preventive effect against infection with RSV and this effect is observed particularly in infants less than 6 months of age.

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