Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2031240735 | Other Identifier | Japan Registry of Clinical Trials |
Not provided
Not provided
Not provided
Study was terminated by Sponsor; the decision was not due to any safety findings.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Pediatric participants will be enrolled as follows:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Part A (Group 2) - Obeldesivir (ODV) | Experimental | Participants weighing ≥ 12 kg to < 20 kg, will receive ODV 175 mg, orally, twice on Day 1, followed by ODV 116.6 mg, orally, twice daily on Days 2 to 5. |
|
| Cohort 1: Part A (Group 3) - ODV | Experimental | Participants weighing ≥ 6 kg to < 12 kg, will receive ODV 116.6 mg, orally, twice on Day 1, followed by ODV 58.3 mg, orally, twice daily on Days 2 to 5. |
|
| Cohort 1: Part A (Group 3) - Placebo | Placebo Comparator | Participants weighing ≥ 6 kg to < 12 kg, will receive placebo-to-match ODV, orally, twice daily on Days 1 to 5. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obeldesivir | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) by Day 28 | TEAEs were defined as any adverse events that began on or after the date of first dose of study drug up to the date of last dose of study drug up to Day 28. The percentage of participants who experienced at least one TEAE was assessed from Day 1 through Day 28. | Up to Day 28 |
| Percentage of Participants Who Experienced Grade 3 or 4 Treatment-Emergent Laboratory Abnormalities by Day 28 | A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and including the date of last study drug dose up to Day 28. A treatment-emergent laboratory abnormality severity was graded according to the Division of AIDS (DAIDS) Version 2.1. Grade 0: Values that do not meet the criteria for an abnormality of at least Grade 1;Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Potentially life-threatening. The percentage of participants who experienced Grade 3 or 4 laboratory abnormalities was assessed from Day 1 through Day 28. | Up to Day 28 |
| Time to Alleviation of Targeted Respiratory Syncytial Virus (RSV) Symptoms by Day 28 | Alleviation of targeted RSV symptoms was defined as achievement of 2 consecutive daily assessments with improvement in score by at least 1 point for any targeted RSV symptom with baseline score is > 1, or no increase in score for any targeted RSV symptom with baseline score of 1, assessed from Day 1 to Day 28. The time to alleviation of targeted RSV symptoms by Day 28 was calculated as the symptom alleviation date minus the first dose date. Targeted RSV symptoms referred to the RSV symptoms (cough, respiratory signs, RSV signs, behavior impact). | Up to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| PK Parameter: AUCtau of GS-441524, Metabolite of Obeldesivir | AUCtau is defined as area under the plasma concentration-time curve during a dosing interval (AUCtau) of GS-441524, the active metabolite of obeldesivir. | Day 5 (predose, 2.5, and 3.5 hours post-dose) |
| PK Parameter: Cmax of GS-441524, Metabolite of Obeldesivir |
Not provided
Key Inclusion Criteria:
Participants assigned male or female at birth, from birth to < 5 years of age who meet one of the following criteria, where permitted according to local law and approved nationally and by relevant institutional review board or independent ethics committee:
RSV infection diagnosis ≤ 3 days prior to randomization.
Negative test for influenza A/B, and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 infection) ≤ 7 days prior to randomization.
Onset of RSV signs or symptoms ≤ 3 days prior to randomization.
Presence of at least 1 sign or symptom of RSV infection at screening and at randomization.
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's of Alabama | Birmingham | Alabama | 35233 | United States | ||
| Midway Medical Clinic |
Not provided
| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
7 participants were screened. The study was terminated early after 4 participants were enrolled. The decision was not based on any safety findings. The study was planned to include Cohort 1 Part A (inclusive of 4 groups based on participant's weight), Cohort 1 Part B, and Cohort 2. Due to the early termination, only Cohort 1 Part A (Groups 2 and 3) were enrolled.
Participants were enrolled at study sites in the United States.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Part A (Group 2) - Obeldesivir (ODV) | Participants weighing ≥ 12 kg to < 20 kg, received ODV 175 mg, orally, twice on Day 1, followed by ODV 116.6 mg, orally, twice daily on Days 2 to 5. |
| FG001 | Cohort 1: Part A (Group 3) - ODV |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 27, 2024 | Mar 17, 2026 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Obeldesivir Placebo | Drug | Administered orally |
|
Cmax is defined as maximum plasma concentration of GS-441524, the active metabolite of obeldesivir. |
| Day 1 (0.25, 0.75, and 2 hours post-dose); Day 5 (predose, 2.5, and 3.5 hours post-dose) |
| PK Parameter: Ctrough of GS-441524, Metabolite of Obeldesivir | Ctrough is defined as the trough observed drug concentration [measured concentration at predose of Day 5 (taken directly before next administration)]. | Day 5: Predose |
| Change From Baseline in RSV Nasal Swab Viral Load at Day 5 | Nasal swab samples was used to assess RSV viral load by reversetranscriptase-quantitative polymerase chain reaction (RT-qPCR), respiratory coinfection by multiplex respiratory pathogen PCR, potential infectious viral titer assessment, and potential resistance testing (by sequencing and/or phenotyping). Baseline was defined as the last available value collected on or prior to first dose of study drug. | Baseline, Day 5 |
| Time to Sustained Alleviation of Targeted RSV Symptoms by Day 28 | Sustained alleviation of targeted RSV symptoms was defined as 3 daily consecutive assessments (48-hour period) with improvement in score by at least 1 point for any targeted RSV symptom with baseline score is > 1; or no increase in score for any targeted RSV symptom with baseline score of 1, assessed from Day 1 to Day 28. The time to sustained alleviation of targeted RSV symptoms by Day 28 was calculated as the symptom alleviation date minus the first dose date. Targeted RSV symptoms referred to the RSV symptoms (cough, respiratory signs, RSV signs, behavior impact). | Up to Day 28 |
| Time to Resolution of Targeted RSV Symptoms by Day 28 | Resolution of targeted RSV symptoms was defined as: for 2 daily consecutive assessments, improvement in score resulting in score of ≤2 for any targeted RSV symptom with baseline score >2; no increase or an improvement in score resulting in score of ≤2 for any targeted RSV symptom with baseline score of 2; no increase in score for any targeted RSV symptom with baseline score of 1. The time to resolution of targeted RSV symptoms by Day 28 was calculated as the resolution date/time minus the first dose date/time. Targeted RSV symptoms referred to RSV symptoms (cough, respiratory signs, RSV signs, behavior impact). | Up to Day 28 |
| Number of Participants With Palatability Questionnaire Response as Assessed by the Caregiver at Days 1 and 5 | Caregivers were asked to rate how the study drug tasted to their child. A questionnaire was administered to caregivers to assess palatability. Palatability was assessed by caregivers using a questionnaire on Day 1 and Day 5 with response options: Super Good, Good, Maybe Good or Maybe Bad, Bad, or Super Bad. | Days 1 and 5 |
| Number of Participants With Acceptability Questionnaire Response as Assessed by the Caregiver at Days 1 and 5 | Caregivers were asked to evaluate how easy it was for children to take the study drug. A questionnaire was administered to caregivers to assess acceptability. Acceptability was assessed by caregivers using a questionnaire with response options: Super Easy, Easy, Maybe Easy or Maybe Hard, Hard, or Super Hard. The questionnaire evaluated how easy it was for children to take the study drug. | Days 1 and 5 |
| Oneonta |
| Alabama |
| 35121 |
| United States |
| Cohen Children's Medical Center Pharmacy New Pavillion | Phoenix | Arizona | 11040 | United States |
| Velocity Clinical Research, Phoenix | Phoenix | Arizona | 85015 | United States |
| UCLA (Outpatient Clinic) | Los Angeles | California | 90095 | United States |
| Alliance Research Institute | Lynwood | California | 90262 | United States |
| Paradigm Clinical Research | Modesto | California | 95355 | United States |
| Paradigm Clinical Research Centers, LLC | San Diego | California | 92108 | United States |
| FOMAT - Jeffrey Kaplan MD Inc Pediatric Medicine | Santa Maria | California | 93454 | United States |
| Velocity Clinical Research, Washington DC | Washington D.C. | District of Columbia | 20016 | United States |
| Dolphin Medical Research | Doral | Florida | 33172 | United States |
| Nona Pediatric Center | Orlando | Florida | 32829 | United States |
| PAS Research | Tampa | Florida | 33613 | United States |
| Rophe Adult and Pediatric Medicine/SKYCRNG | Union City | Georgia | 30291 | United States |
| Clinical Research Prime | Idaho Falls | Idaho | 83404 | United States |
| Velocity Clinical Research, Sioux City | Sioux City | Iowa | 51106 | United States |
| Velocity Clinical Research, Lafayette | Lafayette | Louisiana | 70508 | United States |
| Boeson Research | Great Falls | Montana | 59405 | United States |
| Boeson Research | Kalispell | Montana | 59901 | United States |
| Boeson Research | Missoula | Montana | 59804 | United States |
| Velocity Clinical Research - Norfolk | Norfolk | Nebraska | 68701 | United States |
| Velocity Clinical Research, Omaha | Omaha | Nebraska | 68134 | United States |
| Child Health Care Associates | Syracuse | New York | 13210 | United States |
| Epic Medical Research -Oklahoma | Chickasha | Oklahoma | 73018 | United States |
| Tekton Research, LLC | Yukon | Oklahoma | 73099 | United States |
| PAS Research | Pittsburgh | Pennsylvania | 15227 | United States |
| Helios Clinical Research | Burleson | Texas | 76028 | United States |
| Epic Medical Research - DeSoto | DeSoto | Texas | 75115 | United States |
| PAS Research | Edinburg | Texas | 78539 | United States |
| Helios Clinical Research | Houston | Texas | 77008 | United States |
| Biopharma Informatic, LLC | Houston | Texas | 77043 | United States |
| Sunrise Pediatrics | Houston | Texas | 77077 | United States |
| Biopharma Informatic, LLC | Houston | Texas | 77084 | United States |
| Pioneer Research Solutions Inc. | Houston | Texas | 77099 | United States |
| Radiance Clinical Research | Lampasas | Texas | 76550 | United States |
| Pediatric Center | Richmond | Texas | 77469 | United States |
| Central Texas Medical Research, LLC | San Antonio | Texas | 78232 | United States |
| North Houston Internal Medicine and Pediatric Clinic | Tomball | Texas | 77375 | United States |
| Tanner Clinic | Kaysville | Utah | 84037 | United States |
| Tanner Clinic | Layton | Utah | 84041 | United States |
| Boeson Research PVU | Provo | Utah | 84604 | United States |
| Yoshimura Child Clinic | Akashi | 674-0068 | Japan |
| Japan Community Healthcare Organization Kyushu Hospital | Fkitakyushu | 806-0034 | Japan |
| Uchida child clinic | Fukuoka | 814-0104 | Japan |
| Shindo Children's Clinic | Fukuoka | 814-0121 | Japan |
| SEKI Children's CLINIC | Fukuoka | 814-0123 | Japan |
| Ryuseidai Children's Clinic | Ibaraki | 305-0008 | Japan |
| Isesaki Municipal Hospital | Isesaki | 372-0817 | Japan |
| Abe Child Clinic | Kanagawa | 223-0051 | Japan |
| Okada Kodomonomori Clinic | Kasukabe | 344-0011 | Japan |
| Yutaka Children Clinic | Kobe | 651-2273 | Japan |
| Kochi Health Sciences Center | Kochi | 781-8555 | Japan |
| Japan Community Healthcare Organization Chukyo Hospital | Nagoya | Japan |
| Shimamura Memorial Hospital | Nerima-ku | 177-0051 | Japan |
| Shizuoka Welfare Hospital | Shizuoka | 420-0005 | Japan |
| Shizuoka City Shimizu Hospital | Shizuoka | 424-8636 | Japan |
Participants weighing ≥ 6 kg to < 12 kg, received ODV 116.6 mg, orally, twice on Day 1, followed by ODV 58.3 mg, orally, twice daily on Days 2 to 5. |
| FG002 | Cohort 1: Part A (Group 3) - Placebo | Participants weighing ≥ 6 kg to < 12 kg, received placebo-to-match ODV, orally, twice daily on Days 1 to 5. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Safety Analysis Set included all study participants who were randomized into the study and had received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Part A (Group 2) - Obeldesivir (ODV) | Participants weighing ≥ 12 kg to < 20 kg, received ODV 175 mg, orally, twice on Day 1, followed by ODV 116.6 mg, orally, twice daily on Days 2 to 5. |
| BG001 | Cohort 1: Part A (Group 3) - ODV | Participants weighing ≥ 6 kg to < 12 kg, received ODV 116.6 mg, orally, twice on Day 1, followed by ODV 58.3 mg, orally, twice daily on Days 2 to 5. |
| BG002 | Cohort 1: Part A (Group 3) - Placebo | Participants weighing ≥ 6 kg to < 12 kg, received placebo-to-match ODV, orally, twice daily on Days 1 to 5. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | months |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) by Day 28 | TEAEs were defined as any adverse events that began on or after the date of first dose of study drug up to the date of last dose of study drug up to Day 28. The percentage of participants who experienced at least one TEAE was assessed from Day 1 through Day 28. | The Safety Analysis Set included all study participants who were randomized into the study and had received at least 1 dose of study drug. | Posted | Number | percentage of participants | Up to Day 28 |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Experienced Grade 3 or 4 Treatment-Emergent Laboratory Abnormalities by Day 28 | A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and including the date of last study drug dose up to Day 28. A treatment-emergent laboratory abnormality severity was graded according to the Division of AIDS (DAIDS) Version 2.1. Grade 0: Values that do not meet the criteria for an abnormality of at least Grade 1;Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Potentially life-threatening. The percentage of participants who experienced Grade 3 or 4 laboratory abnormalities was assessed from Day 1 through Day 28. | Participants in the Safety Analysis Set were analyzed. | Posted | Number | percentage of participants | Up to Day 28 |
| ||||||||||||||||||||||||||||||||||
| Primary | Time to Alleviation of Targeted Respiratory Syncytial Virus (RSV) Symptoms by Day 28 | Alleviation of targeted RSV symptoms was defined as achievement of 2 consecutive daily assessments with improvement in score by at least 1 point for any targeted RSV symptom with baseline score is > 1, or no increase in score for any targeted RSV symptom with baseline score of 1, assessed from Day 1 to Day 28. The time to alleviation of targeted RSV symptoms by Day 28 was calculated as the symptom alleviation date minus the first dose date. Targeted RSV symptoms referred to the RSV symptoms (cough, respiratory signs, RSV signs, behavior impact). | The Full Analysis Positive Set included all randomized participants who received at least 1 dose of study drug and were RSV positive at baseline by a central laboratory test. | Posted | Median | Full Range | days | Up to Day 28 |
| |||||||||||||||||||||||||||||||||
| Secondary | PK Parameter: AUCtau of GS-441524, Metabolite of Obeldesivir | AUCtau is defined as area under the plasma concentration-time curve during a dosing interval (AUCtau) of GS-441524, the active metabolite of obeldesivir. | The PK Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least 1 non-missing result for PK evaluation of GS-441524. | Posted | Mean | Standard Deviation | nanograms times hours per mL(ng*h/mL) | Day 5 (predose, 2.5, and 3.5 hours post-dose) |
|
| ||||||||||||||||||||||||||||||||
| Secondary | PK Parameter: Cmax of GS-441524, Metabolite of Obeldesivir | Cmax is defined as maximum plasma concentration of GS-441524, the active metabolite of obeldesivir. | Participants in the PK Analysis Set were analyzed. | Posted | Mean | Standard Deviation | ng/mL | Day 1 (0.25, 0.75, and 2 hours post-dose); Day 5 (predose, 2.5, and 3.5 hours post-dose) |
|
| ||||||||||||||||||||||||||||||||
| Secondary | PK Parameter: Ctrough of GS-441524, Metabolite of Obeldesivir | Ctrough is defined as the trough observed drug concentration [measured concentration at predose of Day 5 (taken directly before next administration)]. | Participants in the PK Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | ng/mL | Day 5: Predose |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in RSV Nasal Swab Viral Load at Day 5 | Nasal swab samples was used to assess RSV viral load by reversetranscriptase-quantitative polymerase chain reaction (RT-qPCR), respiratory coinfection by multiplex respiratory pathogen PCR, potential infectious viral titer assessment, and potential resistance testing (by sequencing and/or phenotyping). Baseline was defined as the last available value collected on or prior to first dose of study drug. | The Virology Analysis Set included all randomized participants who received at least 1 dose of study drug and had baseline RSV viral load greater than or equal to lower limit of quantitation (LLOQ). | Posted | Number | log10 copies/mL | Baseline, Day 5 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Time to Sustained Alleviation of Targeted RSV Symptoms by Day 28 | Sustained alleviation of targeted RSV symptoms was defined as 3 daily consecutive assessments (48-hour period) with improvement in score by at least 1 point for any targeted RSV symptom with baseline score is > 1; or no increase in score for any targeted RSV symptom with baseline score of 1, assessed from Day 1 to Day 28. The time to sustained alleviation of targeted RSV symptoms by Day 28 was calculated as the symptom alleviation date minus the first dose date. Targeted RSV symptoms referred to the RSV symptoms (cough, respiratory signs, RSV signs, behavior impact). | Participants in the Full Analysis Positive Set were analyzed. | Posted | Median | Full Range | days | Up to Day 28 |
| |||||||||||||||||||||||||||||||||
| Secondary | Time to Resolution of Targeted RSV Symptoms by Day 28 | Resolution of targeted RSV symptoms was defined as: for 2 daily consecutive assessments, improvement in score resulting in score of ≤2 for any targeted RSV symptom with baseline score >2; no increase or an improvement in score resulting in score of ≤2 for any targeted RSV symptom with baseline score of 2; no increase in score for any targeted RSV symptom with baseline score of 1. The time to resolution of targeted RSV symptoms by Day 28 was calculated as the resolution date/time minus the first dose date/time. Targeted RSV symptoms referred to RSV symptoms (cough, respiratory signs, RSV signs, behavior impact). | Participants in the Full Analysis Positive Set were analyzed. | Posted | Median | Full Range | days | Up to Day 28 |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Palatability Questionnaire Response as Assessed by the Caregiver at Days 1 and 5 | Caregivers were asked to rate how the study drug tasted to their child. A questionnaire was administered to caregivers to assess palatability. Palatability was assessed by caregivers using a questionnaire on Day 1 and Day 5 with response options: Super Good, Good, Maybe Good or Maybe Bad, Bad, or Super Bad. | Participants in the Safety Analysis Set with available responses to the question at the visit were analyzed. | Posted | Count of Participants | Participants | Days 1 and 5 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Acceptability Questionnaire Response as Assessed by the Caregiver at Days 1 and 5 | Caregivers were asked to evaluate how easy it was for children to take the study drug. A questionnaire was administered to caregivers to assess acceptability. Acceptability was assessed by caregivers using a questionnaire with response options: Super Easy, Easy, Maybe Easy or Maybe Hard, Hard, or Super Hard. The questionnaire evaluated how easy it was for children to take the study drug. | Participants in the Safety Analysis Set were analyzed. | Posted | Count of Participants | Participants | Days 1 and 5 |
|
All-cause Mortality and Adverse Events: Up to 5 days plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: The Safety Analysis Set included all study participants who were randomized into the study and had received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: Part A (Group 2) - Obeldesivir (ODV) | Participants weighing ≥ 12 kg to < 20 kg, received ODV 175 mg, orally, twice on Day 1, followed by ODV 116.6 mg, orally, twice daily on Days 2 to 5. | 0 | 1 | 0 | 1 | 0 | 1 |
| EG001 | Cohort 1: Part A (Group 3) - ODV | Participants weighing ≥ 6 kg to < 12 kg, received ODV 116.6 mg, orally, twice on Day 1, followed by ODV 58.3 mg, orally, twice daily on Days 2 to 5. | 0 | 2 | 1 | 2 | 2 | 2 |
| EG002 | Cohort 1: Part A (Group 3) - Placebo | Participants weighing ≥ 6 kg to < 12 kg, received placebo-to-match ODV, orally, twice daily on Days 1 to 5. | 0 | 1 | 0 | 1 | 1 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (28.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (28.1) | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA (28.1) | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA (28.1) | Systematic Assessment |
| |
| Metapneumovirus infection | Infections and infestations | MedDRA (28.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (28.1) | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 17, 2025 | Mar 17, 2026 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided
| ≥ 2 to < 5 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Participants weighing ≥ 6 kg to < 12 kg, received placebo-to-match ODV, orally, twice daily on Days 1 to 5. |
|
|
Participants weighing ≥ 6 kg to < 12 kg, received placebo-to-match ODV, orally, twice daily on Days 1 to 5. |
|
|
|
|
|
|
|
Participants weighing ≥ 6 kg to < 12 kg, received placebo-to-match ODV, orally, twice daily on Days 1 to 5.
|
|
Participants weighing ≥ 6 kg to < 12 kg, received placebo-to-match ODV, orally, twice daily on Days 1 to 5.
|
|
|
|
|
|