Obeldesivir for RSV

Recruiting at 54 trial locations

Overseen By Gilead Clinical Study Information Center

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Gilead Sciences

Must not be taking: Antivirals, Antibacterials

Disqualifiers: Asthma, Cystic fibrosis, Immunocompromised, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 5 days

130 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have taken certain antiviral medications for RSV within 28 days before joining. It's best to discuss your current medications with the trial team.

What safety data exists for Obeldesivir or similar treatments?

There is no specific safety data available for Obeldesivir, but similar antiviral drugs like remdesivir have been associated with adverse reactions. Remdesivir, used for COVID-19, had limited safety data initially, and monitoring for adverse reactions was necessary. ^{1 2 3 4 5}

How is the drug Obeldesivir different from other treatments for RSV?

Obeldesivir is unique because it is an oral prodrug that targets the RNA-dependent viral RNA polymerase, a mechanism that is different from the commonly used inhaled ribavirin for RSV. This oral administration could offer a more convenient and potentially less costly alternative to existing treatments. ^{6 7 8 9 10}

What is the purpose of this trial?

The goal of this clinical study is to check if obeldesivir (ODV; GS-5245) is safe and well-tolerated by children with respiratory syncytial virus (RSV) infection. It will also look at how well ODV helps reduce the time it takes for children to feel better and for their RSV symptoms to improve. The primary objectives of this study are: a) to evaluate the safety and tolerability of ODV in pediatric participants with RSV infection; b) To evaluate the efficacy of ODV on time to alleviation of targeted RSV symptoms in pediatric participants with RSV infection.

Research Team

Gilead Study Director

Principal Investigator

Gilead Sciences

Eligibility Criteria

This trial is for infants and children with RSV infection, diagnosed within 3 days before joining the study. They must weigh at least 1.5 kg but less than 40 kg (or less than 6 kg for newborns), have no flu or COVID-19, and show symptoms of RSV at screening.

Inclusion Criteria

I am a child or infant over 4 weeks old and weigh between 1.5 kg and less than 40 kg.

My newborn weighs between 1.5 kg and less than 6 kg.

I was diagnosed with RSV less than 3 days ago.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive age and weight appropriate doses of Obeldesivir or placebo

5 days

Daily visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Obeldesivir

Trial Overview The study tests Obeldesivir's safety and effectiveness in reducing symptom duration in kids with RSV. Participants will either receive Obeldesivir or a placebo to compare outcomes.

Participant Groups

Group I: Obeldesivir Placebo Experimental Treatment 1 Intervention

Participants will receive an age and weight appropriate ODV placebo dose based on their cohort/group assignment.

Group II: Obeldesivir Experimental Treatment 1 Intervention

Participants will receive an age and weight appropriate ODV dose based on their cohort/group assignment.

Who Is Running the Clinical Trial?

Gilead Sciences

Lead Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

Findings from Research

A total of 612 adverse drug reaction reports related to molnupiravir were submitted to the FDA, with a significant portion (56.37%) indicating serious outcomes, highlighting the need for ongoing safety monitoring.

Common adverse reactions included diarrhea, rash, and nausea, which align with previous safety evaluations, but the unexpectedly high rate of serious reactions suggests caution in its use and further investigation is warranted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Profile of Molnupiravir in the Treatment of COVID-19: A Descriptive Study Based on FAERS Data. Santi Laurini, G., Montanaro, N., Motola, D.[2023]

Remdesivir was the most commonly reported medication for COVID-19 in the WHO database, with 4944 individual case safety reports (ICSRs) indicating that 93% of these cases identified remdesivir as the sole suspect medicine, highlighting its widespread use.

The analysis revealed significant adverse drug reactions (ADRs) associated with remdesivir, including liver dysfunction, kidney injury, and bradycardia, suggesting new safety concerns that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remdesivir in the COVID-19 Pandemic: An Analysis of Spontaneous Reports in VigiBase During 2020. Rocca, E., Gauffin, O., Savage, R., et al.[2022]

A study analyzing 2,285 adverse event reports related to molnupiravir found that older adults (65 years and older) and women were more likely to report adverse events, particularly gastrointestinal and skin disorders.

Molnupiravir showed a lower risk of serious adverse events compared to other antiviral drugs like remdesivir in patients under 65, but elderly patients still require close safety monitoring due to higher risks of various disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events associated with molnupiravir: a real-world disproportionality analysis in food and drug administration adverse event reporting system. Liang, Y., Ma, L., Wang, Y., et al.[2023]

In a survey of 2,849 individuals aged 18-49 who completed mRNA COVID-19 vaccinations, about 90% reported adverse events (AEs), with 3.3% after the first dose and 4.3% after the second dose experiencing severe AEs.

Factors associated with a higher incidence of AEs included receiving the mRNA-1273 vaccine, being female, having dermatologic diseases, and a history of serious allergic reactions or anticoagulant medication use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Nationwide Survey of mRNA COVID-19 Vaccinee's Experiences on Adverse Events and Its Associated Factors. Yoon, D., Jeon, HL., Noh, Y., et al.[2023]

A postmarketing analysis of 31,024 adverse event reports linked to rofecoxib revealed a significant incidence of serious adverse events, particularly hemorrhage, thrombosis, and embolism, with a notable risk increase in patients using anticoagulants or NSAIDs.

The data suggests that rofecoxib users face heightened risks for cardiovascular issues and hemorrhagic events, especially among older males and those taking blood thinners, indicating a need for careful monitoring in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postmarketing surveillance of serious adverse events associated with the use of rofecoxib from 1999-2002. Bottone, FG., Barry, WT.[2019]

Oral ribavirin, combined with corticosteroids, effectively treated respiratory syncytial virus (RSV) infection in lung transplant patients, with no complications or deaths reported during the treatment period.

The treatment was significantly more cost-effective, costing $700 for a 10-day course compared to $14,000 for nebulized ribavirin, while also restoring lung function (FEV1) to baseline levels after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of oral ribavirin in lung transplant patients with respiratory syncytial virus lower respiratory tract infection. Pelaez, A., Lyon, GM., Force, SD., et al.[2021]

GS-5245, an oral prodrug targeting the RNA-dependent viral RNA polymerase, shows broad antiviral activity against multiple coronaviruses, including SARS-CoV-2 variants like BA.1, in vitro and in mouse models.

In combination with the protease inhibitor nirmatrelvir, GS-5245 demonstrated increased efficacy against SARS-CoV-2, suggesting it could be a valuable addition to treatment strategies for COVID-19, particularly for patients needing more effective therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the oral nucleoside prodrug GS-5245 (Obeldesivir) against SARS-CoV-2 and coronaviruses with pandemic potential. Martinez, DR., Moreira, FR., Zweigart, MR., et al.[2023]

Presatovir (GS-5806) is a promising oral antiviral that effectively inhibits the fusion of respiratory syncytial virus (RSV) with host cells, showing favorable safety and pharmacokinetic profiles in two phase 1 studies involving healthy adults.

The studies demonstrated that presatovir can be administered once daily without regard to meals, and its exposure increases in a dose-proportional manner, supporting its potential for further clinical trials in treating RSV infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 1 First-in-Human, Single- and Multiple-Ascending Dose, and Food Effect Studies to Assess the Safety, Tolerability, and Pharmacokinetics of Presatovir for the Treatment of Respiratory Syncytial Virus Infection. German, P., Xin, Y., Chien, JW., et al.[2021]

In a study involving healthy adults infected with RSV, presatovir effectively reduced viral load and disease severity in a dose-dependent manner, demonstrating its potential as a treatment for RSV infections.

Although some RSV strains developed resistance to presatovir during treatment, this resistance did not significantly impact the overall clinical outcomes, suggesting that presatovir remains an effective option for managing RSV despite the emergence of resistant strains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Resistance Assessment Following Administration of Respiratory Syncytial Virus (RSV) Fusion Inhibitor Presatovir to Participants Experimentally Infected With RSV. Stray, K., Perron, M., Porter, DP., et al.[2021]

In a Phase 2b trial involving 61 lung transplant recipients with RSV infection, the RSV fusion inhibitor presatovir did not significantly reduce nasal RSV load or improve respiratory symptoms compared to placebo.

Despite the lack of efficacy in reducing RSV levels or improving lung function, presatovir was generally well tolerated by patients, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of presatovir for respiratory syncytial virus after lung transplant. Gottlieb, J., Torres, F., Haddad, T., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Safety Profile of Molnupiravir in the Treatment of COVID-19: A Descriptive Study Based on FAERS Data. [2023]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Remdesivir in the COVID-19 Pandemic: An Analysis of Spontaneous Reports in VigiBase During 2020. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse events associated with molnupiravir: a real-world disproportionality analysis in food and drug administration adverse event reporting system. [2023]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

A Nationwide Survey of mRNA COVID-19 Vaccinee's Experiences on Adverse Events and Its Associated Factors. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Postmarketing surveillance of serious adverse events associated with the use of rofecoxib from 1999-2002. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy of oral ribavirin in lung transplant patients with respiratory syncytial virus lower respiratory tract infection. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Efficacy of the oral nucleoside prodrug GS-5245 (Obeldesivir) against SARS-CoV-2 and coronaviruses with pandemic potential. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Phase 1 First-in-Human, Single- and Multiple-Ascending Dose, and Food Effect Studies to Assess the Safety, Tolerability, and Pharmacokinetics of Presatovir for the Treatment of Respiratory Syncytial Virus Infection. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Drug Resistance Assessment Following Administration of Respiratory Syncytial Virus (RSV) Fusion Inhibitor Presatovir to Participants Experimentally Infected With RSV. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of presatovir for respiratory syncytial virus after lung transplant. [2023]