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PresatovirWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (6)


Name (Synonyms) Correlation
drug912 FFP2 Wiki 0.50
drug1408 MFS Wiki 0.50
drug1902 Presatovir placebo Wiki 0.50
drug919 Facial mask Wiki 0.50
drug904 EyeQue Insight Wiki 0.50
drug1822 Placebo Wiki 0.08

Correlated MeSH Terms (4)


Name (Synonyms) Correlation
D018357 Respiratory Syncytial Virus Infections NIH 0.41
D003141 Communicable Diseases NIH 0.09
D007239 Infection NIH 0.08
D014777 Virus Diseases NIH 0.06

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There are 4 clinical trials

Clinical Trials


1 A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hospitalized Adults With Respiratory Syncytial Virus (RSV) Infection

The primary objective of this study is to evaluate the effects of presatovir on respiratory syncytial virus (RSV) viral load in RSV-positive adults who have been hospitalized with acute respiratory infectious symptoms. Participants will receive 1 dose of presatovir on Day 1 and followed for 27 days postdose. Nasal swabs will be collected at each study visit (excluding Day 28) and assayed for change in viral load as the primary endpoint.

NCT02135614 Respiratory Syncytial Virus Infection Drug: Presatovir Drug: Presatovir placebo
MeSH:Infection Communicable Diseases Respiratory Syncytial Virus Infections

Primary Outcomes

Description: The time-weighted average change, often referred to as the DAVG, provides the average viral burden change from baseline. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.

Measure: Time-Weighted Average Change in Respiratory Syncytial Viral (RSV) Load From Baseline to Day 5

Time: Baseline to Day 5

Secondary Outcomes

Description: The Flu-PRO is a patient-reported outcome questionnaire utilized as a standardized method for evaluating symptoms of influenza. Flu-PRO Score was calculated as the mean of 38 individual scores. Individual scores ranged from 0 (no symptoms) to 4 (worst symptoms). The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.

Measure: Time-weighted Average Change in the Flu-PRO Score From Baseline to Day 5

Time: Baseline to Day 5

Measure: Number of Hospitalization-Free Days Following Presatovir Administration

Time: Up to Day 28

Description: The adjusted rate of unplanned medical encounters (clinic visits, emergency room visits, urgent care visits, and rehospitalizations) related to a respiratory illness after initial hospital discharge through Day 28 will be assessed. Event rate was calculated as the total number of unplanned medical encounters divided by the total number of participants. The mean values presented were adjusted for stratification factor.

Measure: Rate of Unplanned Medical Encounters

Time: Up to Day 28

2 A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hematopoietic Cell Transplant (HCT) Recipients With Respiratory Syncytial Virus (RSV) Infection of the Upper Respiratory Tract

The primary objective of this study is to evaluate the effect of presatovir on respiratory syncytial virus (RSV) viral load in autologous or allogeneic hematopoietic cell transplant (HCT) recipients with an acute RSV upper respiratory tract infection (URTI), the effect of presatovir on development of lower respiratory tract complication, being free of any supplemental oxygen progression to respiratory failure, and pharmacokinetics (PK), safety, and tolerability of presatovir.

NCT02254408 Respiratory Syncytial Virus Drug: Presatovir Drug: Placebo
MeSH:Infection

Primary Outcomes

Description: The time-weighted average change, often referred to as the DAVG, provides the average viral burden change from baseline. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.

Measure: Time-Weighted Average Change in Nasal Respiratory Syncytial Virus (RSV ) Viral Load From Baseline (Day 1) to Day 9

Time: Baseline; Day 9

Description: A Lower Respiratory Tract Complication (LRTC) was defined as one of the below as determined by the adjudication committee: Primary RSV lower respiratory tract infection (LRTI) Secondary bacterial LRTI LRTI due to unusual pathogens Lower respiratory tract complication of unknown etiology

Measure: Percentage of Participants Who Developed a Lower Respiratory Tract Complication

Time: Up to Day 28

Secondary Outcomes

Description: Participants were considered to have an event if either condition is met: Participant develops a respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) or; Participant dies prior to or on Day 28

Measure: Percentage of Participants Who Developed Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) or All-cause Mortality

Time: Up to Day 28

3 A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hematopoietic Cell Transplant (HCT) Recipients With Respiratory Syncytial Virus (RSV) Infection of the Lower Respiratory Tract

The primary objective of this study is to evaluate the effect of presatovir on respiratory syncytial virus (RSV) viral load in autologous or allogeneic hematopoietic cell transplant (HCT) recipients with an acute RSV lower respiratory tract infection (LRTI).

NCT02254421 Respiratory Syncytial Virus Infection Drug: Presatovir Drug: Placebo
MeSH:Infection Communicable Diseases Respiratory Syncytial Virus Infections

Primary Outcomes

Description: The time-weighted average change, often referred to as the DAVG, provides the average viral burden change from baseline. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factors.

Measure: Time-weighted Average Change in Nasal Respiratory Syncytial Viral (RSV) Load From Baseline to Day 9

Time: Baseline to Day 9

Secondary Outcomes

Measure: Number of Supplemental O2-Free Days Through Day 28

Time: Up to Day 28

Measure: Percentage of Participants Developing Respiratory Failure Requiring Mechanical Ventilation Through Day 28

Time: Up to Day 28

Measure: Percentage of All-Cause Mortality Among Participants Through Day 28

Time: Up to Day 28

4 A Phase 2b, Randomized, Controlled Trial Evaluating GS-5806 in Lung Transplant (LT) Recipients With Respiratory Syncytial Virus (RSV) Infection

The primary objective of this study is to evaluate the effect of presatovir on nasal respiratory syncytial virus (RSV) viral load in RSV-positive lung transplant (LT) recipients with acute respiratory symptoms.

NCT02534350 Respiratory Syncytial Virus (RSV) Drug: Presatovir Drug: Placebo
MeSH:Virus Diseases

Primary Outcomes

Measure: Time-Weighted Average Change in Viral Load From Day 1/Baseline Through Day 7 in Participants in the Full Analysis Set

Time: Up to 7 days

Measure: Time-Weighted Average Change in Viral Load From Day 1/Baseline Through Day 7 in a Subset of Participants in the Full Analysis Set Whose Duration of RSV Symptoms Prior to the First Dose of Study Drug is ≤ Median

Time: Up to 7 days

Secondary Outcomes

Description: The Flu-PRO is a patient-reported outcome questionnaire utilized as a standardized method for evaluating symptoms of influenza. Flu-PRO Score was calculated as the mean of 38 individual scores. Individual scores ranged from 0 (no symptoms) to 4 (worst symptoms) for the 5-point severity scale and 0 (never) to 4 or more times (always) for the 5-point frequency scale. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.

Measure: Time-Weighted Average Change in FLU-PRO Score From Day 1/Baseline Through Day 7

Time: Up to 7 days

Description: FEV1 is defined as forced expiratory volume in the first second.

Measure: Percent Change From Study Baseline in FEV1% Predicted Value

Time: Baseline; Day 28


No related HPO nodes (Using clinical trials)