~13 spots leftby Apr 2025

EDP-938 for Respiratory Syncytial Virus (RSVHR Trial)

Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Enanta Pharmaceuticals, Inc
Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests an oral medication called EDP-938 for adults with RSV who are at high risk of severe illness. The goal is to help fight the virus or reduce its impact.
Is the drug EDP-938 a promising treatment for Respiratory Syncytial Virus?The provided research articles do not contain information about EDP-938 or its effectiveness for treating Respiratory Syncytial Virus, so we cannot determine if it is promising based on this data.234510
What safety data is available for EDP-938 in treating RSV?The provided research does not contain any safety data for EDP-938 or its other names like Zelicapavir, EP 023938, Placebo, Control, or Dummy Treatment. The studies focus on erythropoiesis-stimulating agents and roxadustat, which are unrelated to EDP-938.19111214
What data supports the idea that EDP-938 for Respiratory Syncytial Virus is an effective drug?The available research does not provide any data or information about EDP-938 for Respiratory Syncytial Virus. The articles focus on enhanced recovery pathways for surgical patients, which are unrelated to the effectiveness of EDP-938 as a treatment for Respiratory Syncytial Virus.6781315
Do I need to stop my current medications for this trial?The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you've taken systemic antiviral, antibacterial, antifungal, or antimycobacterial therapy within 7 days before signing the consent form.

Eligibility Criteria

Adults over 65 or those with heart failure, asthma, COPD at high risk for RSV complications can join. They must have recent respiratory symptoms and a positive RSV test. Participants need to use contraception if of childbearing potential. Exclusions include recent COVID-19 infection, severe lung function impairment, certain heart conditions, living in care facilities receiving acute respiratory management, imminent hospitalization need, recent systemic anti-infective therapy or active viral hepatitis/HIV.

Treatment Details

The trial is testing EDP-938 against a placebo in non-hospitalized adults with confirmed RSV who are at high risk for complications. It's a Phase 2b study where participants are randomly assigned to receive either the drug or placebo without knowing which one they're getting (double-blind).
2Treatment groups
Experimental Treatment
Placebo Group
Group I: EDP-938Experimental Treatment1 Intervention
EDP-938 800 mg, once daily
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo, once daily

Find a clinic near you

Research locations nearbySelect from list below to view details:
Allianz Research Institute IncWestminster, CA
Accelemed Research InstituteAustin, TX
Valley Institute of ResearchFort Worth, TX
Acute Care EmergenceColumbus, GA
More Trial Locations
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Who is running the clinical trial?

Enanta Pharmaceuticals, IncLead Sponsor

References

Safety of erythropoiesis stimulating agents in patients on dialysis: current issues for nephrology nurses. [2015]Clinical data have repeatedly shown that the erythropoiesis stimulating agents (ESAs) Epoetin alfa and darbepoetin alfa are safe and efficacious to treat anemia in patients on dialysis when used in accordance with the product label The safety profile of ESAs has recently been updated based on reports from clinical investigations that studied off-label uses of ESAs at doses designed to raise the Hb to above 13.0 g/dL. This article reviews the recent safety data and the current prescribing recommendations, with an emphasis on the need to follow the guidelines found in the products' package inserts to ensure the safe and efficacious use of these agents.
Rilpivirine, a novel non-nucleoside reverse transcriptase inhibitor for the management of HIV-1 infection: a systematic review. [2020]Rilpivirine (RPV) is a second-generation non-nucleoside reverse transcriptase inhibitor (NNRTI). It remains active against HIV strains harbouring mutations that affect first-generation agents. RPV is dosed once daily with food and has been coformulated into a single tablet containing tenofovir and emtricitabine. Two Phase III studies of treatment-naive patients found RPV and efavirenz to have similar safety and efficacy. However, suboptimal virological suppression with RPV occurred more commonly in patients with higher baseline viral loads (>100,000 copies/ml). The most common mutation that emerged during RPV therapy was E138K, which often occurred in combination with M184I. E138K is likely to cause cross-resistance to other NNRTIs thereby limiting the further utilization of this class.
Emtricitabine/rilpivirine/tenofovir disoproxil fumarate single-tablet regimen: a guide to its use in HIV-1 infection. [2021]The once-daily, single-tablet regimen of emtricitabine/rilpivirine/tenofovir disoproxil fumarate (Eviplera™ [EU]; Complera™ [US]) provides a convenient option for antiretroviral therapy in treatment-naive patients with HIV-1 infection. In well designed trials in this patient population, rilpivirine plus emtricitabine/tenofovir disoproxil fumarate was noninferior to efavirenz plus emtricitabine/tenofovir disoproxil fumarate in terms of reducing viral HIV-1 RNA level to
Determinants of use of the fixed dose combination emtricitabine/rilpivirine/tenofovir (Eviplera) in HIV-infected persons receiving care in Italy. [2018]Emtricitabine/rilpivirine/tenofovir (EVP) is a fixed-dose combination of antiretrovirals (ARV) approved by the European Medicines Agency in November 2011 and introduced in Italy in February 2013. It is a once-a-day single tablet and is licensed in Europe for use only in ARV-naïve patients with a viral load (VL) ≤100,000 copies/mL.
The maraviroc expanded access program - safety and efficacy data from an open-label study. [2020]The maraviroc (MVC) expanded access program (EAP) was initiated to increase MVC availability to patients with limited treatment options. Darunavir (DRV), raltegravir (RAL), and etravirine (ETV) were either recently approved or under regulatory review at study initiation and available for coadministration with MVC. Thus, the safety of MVC in combination with new antiretroviral therapies (ARVs) could be assessed. This open-label safety study of MVC was conducted at 262 sites worldwide in 1032 R5 HIV-positive treatment-experienced patients with limited/no therapeutic options.
Initiating an Enhanced Recovery Pathway Program: An Anesthesiology Department's Perspective. [2019]Enhanced recovery pathways (ERPs) for surgical patients may reduce variation in care and improve perioperative outcomes. Mainstays of ERPs are standardized perioperative pathways. At The Johns Hopkins Hospital (Baltimore), an integrated ERP was proposed to further reduce the surgical site infection rate and the longer-than-expected hospital length of stay in colorectal surgery patients.
Enhanced recovery after surgery program in Gynaecologic Oncological surgery in a minimally invasive techniques expert center. [2018]Enhanced Recovery After Surgery Programs (ERP) includes multimodal approaches of perioperative patient's clinical pathways designed to achieve early recovery after surgery and a decreased length of hospital stay (LOS).
The introduction of an enhanced recovery pathway for elective caesarean sections. [2018]This article will focus on the establishment of an enhanced recovery pathway (ERP) for women undergoing elective caesarean section in a busy maternity unit. It will consider the background to this project, the impact on services and the improvements in service that have been achieved as well as the challenges that have been experienced in this process.
Investigating Serious Adverse Drug Reactions in Patients Receiving Erythropoiesis-Stimulating Agents: A Root Cause Analysis Using the "ANTICIPATE" Framework. [2019]Unexpected serious adverse drug reactions (sADRs) affecting patients with chronic kidney disease (CKD) who received erythropoiesis-stimulating agents were identified by study co-authors. These included pure red cell aplasia (PRCA) after administration of the Eprex formulation of epoetin or the epoetin biosimilar HX575 and fatal anaphylaxis associated with peginesatide, an erythropoietin receptor agonist. We developed and applied a structured framework to describe these sADRs, including root cause analyses and eradication efforts.
Switching at Low HIV-1 RNA into Fixed Dose Combinations: TDF/FTC/RPV is non-inferior to TDF/FTC/EFV in first-line suppressed patients living with HIV. [2023]In low- and middle-income countries (LMICs), a substantial unmet need for affordable single-tablet regimen (STR) options remains. Rilpivirine (RPV, TMC278) is formulated in a low-cost STR with tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC).
11.United Statespubmed.ncbi.nlm.nih.gov
Roxadustat for the treatment of anemia in patients with chronic kidney diseases: a meta-analysis. [2022]Anemia is a common complication of chronic kidney disease (CKD). Treating renal anemia with erythropoiesis-stimulating agents (ESAs) or erythropoietin analogs is effective but has side effects. Therefore, we performed a meta-analysis to assess the efficacy and safety of roxadustat in treating CKD-induced anemia.
12.United Statespubmed.ncbi.nlm.nih.gov
Efficacy and Cardiovascular Safety of Roxadustat in Dialysis-Dependent Chronic Kidney Disease: Pooled Analysis of Four Phase 3 Studies. [2022]This integrated phase 3 analysis examined efficacy and cardiovascular safety for roxadustat vs erythropoiesis-stimulating agents (ESAs) in dialysis-dependent patients.
13.United Statespubmed.ncbi.nlm.nih.gov
A Comparison of Adult and Pediatric Enhanced Recovery after Surgery Pathways: A Move for Standardization. [2022]Enhanced recovery protocols (ERP) are a multimodal approach to standardize perioperative care. To substantiate the benefit of a pediatric-centered pathway, we compared outcomes of children treated with pediatric ERP (pERP) versus adult (aERP) pathways. We aimed to compare components of each pathway to create a new comprehensive pERP to reduce variation in care.
Comparison of risk of peritoneal dialysis-associated peritonitis between roxadustat and recombinant human erythropoietin in peritoneal dialysis patients: a retrospective comparative cohort study. [2022]Roxadustat and recombinant human erythropoietin (rhuEPO) have been approved for the treatment of renal anemia in patients undergoing dialysis. The comparison of risk of peritoneal dialysis (PD)-associated peritonitis between roxadustat and rhuEPO in PD patients remains uncertain. We aimed to compare the risk of PD-associated peritonitis between roxadustat and rhuEPO and examine possible modifiers for the comparison in PD patients.
Minimalistic approach to enhanced recovery after pediatric scoliosis surgery. [2023]Prior studies of enhanced recovery protocols (ERP) have been conducted at large institutions with abundant resources. These results may not apply at institutions with less resources directed to quality improvement efforts. The purpose of this study was to assess the value of a minimalistic enhanced recovery protocol in reducing length of stay (LOS) following PSF for adolescent idiopathic scoliosis. We hypothesized that accelerated transition to oral pain medications and mobilization alone could shorten hospital length of stay in the absence of a formal multimodal pain regimen.