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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001803-17 | EudraCT Number |
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The goals of this clinical study are to learn more about the study drug, remdesivir, and how safe it is in participants less than 18 years old with coronavirus disease 2019 (COVID-19).
Pediatric participants will be enrolled as follows:
Pediatric participants ≥ 28 days to < 18 years old:
Term neonatal participants 0 days to < 28 days old:
Preterm neonates and infants 0 days to < 56 days old:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg | Experimental | Participants will receive RDV 200 mg, intravenous (IV) infusion on Day 1 followed by RDV 100 mg, IV infusion, daily, up to 10 days. |
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| RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg | Experimental | Participants will receive RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion, daily, up to 10 days. |
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| RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg | Experimental | Participants will receive RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion, daily, up to 10 days. |
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| RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg | Experimental | Participants will receive RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion, daily, up to 10 days. |
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| RDV, Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg | Experimental | Participants will receive RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion, daily, up to 10 days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remdesivir | Drug | Administered as an intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and/or any AEs leading to premature discontinuation of study drug. | From first dose date (Day 1) up to follow-up assessment (maximum duration: 30 days) |
| Percentage of Participants With Treatment-Emergent Graded Laboratory Abnormalities | Treatment-emergent graded laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any time post baseline up to and including the date of last dose of study drug plus 30 days. The laboratory abnormalities were graded using division of allergy and infectious diseases (DAIDS) scale. DAIDS scale is used to grade the severity of adult and pediatric unwanted medical events. Grade 1: mild event, Grade 2: moderate event, Grade: serious event, Grade 4: potentially life-threatening event. | From first dose date (Day 1) up to follow-up assessment (maximum duration: 30 days) |
| Pharmacokinetic (PK) Parameter: Cmax of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State | Cmax is defined as maximum plasma concentration of drug. Plasma concentrations were drawn as follows: (1) for Cohorts 1-4 and 8 on Day 2 and Day 3 with Day 5 as optional; (2) for Cohorts 5-7 on Day 2 or Day 3. | Day 2: end of infusion and 4 hours post end of infusion, Day 3: pre-infusion and 2 hours post end of infusion, and Day 5: middle of infusion and 6 hours post end of infusion; infusion duration: 30 minutes to 2 hours |
| PK Parameter: AUCtau of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State | AUCtau is defined as area under the concentration versus time curve over the dosing interval. Plasma concentrations were drawn as follows: (1) for Cohorts 1-4 and 8 on Day 2 and Day 3 with Day 5 as optional; (2) for Cohorts 5-7 on Day 2 or Day 3. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical Improvement on a 7-point Ordinal Scale Score | Clinical improvement was defined as ≥ 1-point and ≥ 2-point improvement from Baseline clinical status or recovery or discharged alive on 7-point ordinal scale. Recovery was defined as an improvement from a Baseline score of 2 - 5 to a score of 6 or 7 or an improvement from a Baseline score of 6 to 7 on the ordinal scale. The ordinal scale was used for the assessment of the clinical status at a given day using a 7-point ordinal scale with an increasing score indicating improvement. Scale: 1=Death, 2=Hospitalized, on invasive mechanical ventilation or ECMO, 3=Hospitalized, on non-invasive ventilation or high flow oxygen devices, 4=Hospitalized, requiring low flow supplemental oxygen, 5=Hospitalized, not requiring supplemental oxygen-requiring ongoing medical care COVID-19 related or otherwise), 6=Hospitalized, not requiring supplemental oxygen-no longer required ongoing medical care (other than RDV administration), 7=Not hospitalized. The 95% CI was based on the Clopper-Pearson method. |
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Key Inclusion Criteria:
Aged < 18 years of age who meet one of the following weight criteria (where permitted according to local law and approved nationally and by relevant institutional review board (IRB) or independent ethics committee (IEC)).
Severe acute respiratory syndrome coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR).
Hospitalized and requiring medical care for coronavirus disease 2019 (COVID-19).
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Alabama | Birmingham | Alabama | 35233 | United States | ||
| Children's Hospital Los Angeles |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Ahmed A, Rojo P, Agwu A, Kimberlin D, Deville J, Mendez-Echevarria A, et al. Remdesivir Treatment for COVID-19 in Hospitalized Children: CARAVAN Interim Results [Presentation]. European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) 2022; 2022 23-26 April; Lisbon, Portugal and Online. | ||
| Background | Ahmed A, Rojo P, Agwu A, Kimberlin D, Deville J, Mendez-Echevarria A, et al. Remdesivir Treatment for COVID-19 in Hospitalized Children: CARAVAN Interim Results [Presentation]. Virtual Conference on Retroviruses and Opportunistic Infections (CROI) 2022; 2022c 12-16 February. | ||
| Background | Munoz F, Muller W, Ahmed A, Kimberlin D, Mendez-Echevarria A, Chen JS, et al. Safety and efficacy of Remdesivir in a pediatric COVID-19 population (CROI) [Abstract 617]. Topics in antiviral medicine 2021;29 (1):237. | ||
| Background | Pikora C, Bamford A, Luzuriaga K, Wiznia A, Rojo Conejo P, Muller B, et al. Challenges of remdesivir pediatric development for SARS-CoV-2 infection in a pandemic. 12th International Workshop on HIV Pediatrics; 2020 November 16-17; Virtual Event. |
| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy#Commitment
18 months after study completion
A secured external environment with username, password, and RSA code.
60 participants were screened.
Participants were enrolled at study sites in Italy, Spain, the United Kingdom, and the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg | Participants received RDV 200 mg, intravenous (IV) infusion on Day 1 followed by RDV 100 mg, IV infusion daily up to 10 days. |
| FG001 | RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 6, 2022 | Sep 26, 2023 |
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| RDV, Cohort 6: Age 0 to < 14 Days of Age, Gestational Age > 37 Weeks, and Birth Weight ≥ 2.5 kg | Experimental | Participants will receive RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV, daily, up to 10 days. |
|
| RDV, Cohort 7: Age 0 to < 56 Days of Age, Gestational Age ≤ 37 Weeks, and Birth Weight ≥ 1.5 kg | Experimental | Participants will receive RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV, daily, up to 10 days. |
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| RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg | Experimental | Participants will receive RDV 200 mg, IV infusion on Day 1 followed by RDV 100 mg, IV infusion daily up to 10 days. |
|
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| Day 2: end of infusion and 4 hours post end of infusion, Day 3: pre-infusion and 2 hours post end of infusion, and Day 5: middle of infusion and 6 hours post end of infusion; infusion duration: 30 minutes to 2 hours |
| Day 10 |
| Time (Days) to Discharge From Hospital | Time to discharge was the duration from the first dose date to getting discharged from the hospital. | From first dose date (Day 1) up to follow-up assessment (maximum duration: 30 days) |
| Number of Participants With Change From Baseline in Oxygenation Use | Oxygen support status was derived from the 7-point ordinal scale score, 1 = death; 2 = invasive mechanical ventilation; 3 = high flow oxygen; 4 = low flow oxygen; 5 or 6 = room air; 7 = discharge. Change from Baseline for participants with oxygenation use status as '3=High Flow Oxygen', '4=Low Flow Oxygen' and '5=Room Air' at Baseline. | Day 10 |
| Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) | Mechanical ventilation status was derived from the 7-point ordinal scale score, 1 = death; 2 = invasive mechanical ventilation; 3 = high flow oxygen; 4 = low flow oxygen; 5 or 6 = room air; 7 = discharge. | Day 10 |
| Days to First Confirmed Negative Polymerase Chain Reaction (PCR) Result | Confirmed negative PCR is defined by as 2 consecutive negative PCR results or negative result at the last available sample for participants who completed or discontinued from the study. The assessment were done for the samples: nasal/oropharyngeal (OP), nasopharyngeal (NP)/oropharyngeal (OP), endotracheal (ET) aspirates, and rectal/fecal swabs. | From first dose date (Day 1) up to follow-up assessment (maximum duration: 30 days) |
| Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load Up to Day 10 or Up to the First Confirmed Negative PCR Result | Change from baseline in SARS-CoV-2 viral load up to Day 10 or up to the first negative PCR result with confirmation (whichever comes first) were reported. The assessment were done for the samples: nasal/oropharyngeal (OP) samples, nasopharyngeal (NP)/OP samples, endotracheal (ET) aspirates, and rectal/fecal swabs. | Baseline, Day 10, and Day of Discharge (Day 10 or before) |
| Bilirubin Concentrations in < 14-day-old Participants | From first dose date (Day 1) up to follow-up assessment (maximum duration: 30 days) |
| Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale | The PEWS was measured by 3 components, where 1= behavior, 2= perfusion assessed by capillary refill and heart rate, and 3= respiratory status assessed by respiratory rate, effort, and oxygen requirement. The score ranged between 0 to 9 point, with higher score representing the highest severity level. A negative change from baseline value indicated an improvement. Data are reported for participants with a PEWS behavior score ≥ 2 at baseline, and a ≥ 2-point improvement (indicated by a decrease) in PEWS behavior score by Day 10, participants with a PEWS behavior score ≥ 1 at baseline, with ≥ 1-point improvement in PEWS behavior score by Day 10 and participants who recovered in PEWS behavior, defined as a Baseline score of 1 through 3 improved to a score of 0. | Day 10 |
| Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD) | Plasma concentrations were drawn as follows: (1) for Cohorts 1-4 and 8 on Day 2 and Day 3, with Day 5 as optional; (2) for Cohorts 5-7 on Day 2 or Day 3. | Day 2: end of infusion and 4 hours post end of infusion, Day 3: pre-infusion and 2 hours post end of infusion, and Day 5: middle of infusion and 6 hours post end of infusion; infusion duration: 30 minutes to 2 hours |
| Percentage of Participants With Concomitant Use of Medications Other Than RDV for Treatment of COVID-19 | Participants who received at least one concomitant non-study COVID-19 medication from the first day of RDV treatment through the 30-day Follow-up visit or early withdrawal are reported. | first dose date (Day 1) up to follow-up assessment (maximum duration: 30 days) |
| Los Angeles |
| California |
| 90027 |
| United States |
| Ronald Reagan University of California, Los Angeles Medical Center | Los Angeles | California | 90095 | United States |
| Valley Children's Hospital | Madera | California | 93636 | United States |
| UC Davis Medical center | Sacramento | California | 95817 | United States |
| Rady Children's Hospital San Diego | San Diego | California | 92123 | United States |
| Tampa General Hospital (Inpatient Visits) | Tampa | Florida | 33606 | United States |
| Ann & Robert H. Lurie Children's Hospital | Chicago | Illinois | 60611 | United States |
| Norton Children's Hospital | Louisville | Kentucky | 40202 | United States |
| Tulane University School of Medicine | New Orleans | Louisiana | 70112 | United States |
| Johns Hopkins Children's Center | Baltimore | Maryland | 21287 | United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| Spectrum Health/Helen De Vos Children's Hospital | Grand Rapids | Michigan | 49503 | United States |
| Children's Minnesota | Minneapolis | Minnesota | 55404 | United States |
| Northwell Health-Cohen Children's Medical Center | New Hyde Park | New York | 11040 | United States |
| NYC Health + Hospitals/Jacobi Medical Center | The Bronx | New York | 10461 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Carolinas Medical Center-Levine Children's Hospital | Charlotte | North Carolina | 28203 | United States |
| Lehigh Valley Hospital/Lehigh Valley Health Network (LVH/LVHN) | Allentown | Pennsylvania | 18103 | United States |
| St. Christopher's Hospital for Children | Philadelphia | Pennsylvania | 19134 | United States |
| Children's Medical Center | Dallas | Texas | 75235 | United States |
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| Azienda Ospedaliero Universitaria Meyer | Florence | 50139 | Italy |
| Azienda Ospedaliera di Padova - Dipartimento Salute della Donna e del Bambino | Padova | 35128 | Italy |
| UO Clinica Pediatrica, Ospedale Pietro Barilla - AOU di Parma | Parma | 43126 | Italy |
| Hospital Universitari Vall D'Hebron | Barcelona | 8035 | Spain |
| Hospital Sant Joan de Déu | Esplugues de Llobregat | 8950 | Spain |
| Hospital General Universitario Gregorio Maranon | Madrid | 28009 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | 28041 | Spain |
| Hospital Clínico Universitario de Santiago | Santiago de Compostela | 15706 | Spain |
| Alder Hey Children's NHS Foundation Trust | Liverpool | L12 2AP | United Kingdom |
Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. |
| FG002 | RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg | Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. |
| FG003 | RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg | Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. |
| FG004 | RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg | Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. |
| FG005 | RDV, Cohort 6: Age 0 to < 14 Days of Age, Gestational Age > 37 Weeks, and Birth Weight ≥ 2.5 kg | Participants received RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV infusion daily up to 10 days. |
| FG006 | RDV, Cohort 7: Age 0 to < 56 Days of Age, Gestational Age ≤ 37 Weeks, and Birth Weight ≥ 1.5 kg | Participants received RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV infusion daily up to 10 days. |
| FG007 | RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg | Participants received RDV 200 mg, IV infusion on Day 1 followed by RDV 100 mg, IV infusion daily up to 10 days. |
| COMPLETED |
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| NOT COMPLETED |
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The Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg | Participants received RDV 200 mg, intravenous (IV) infusion on Day 1 followed by RDV 100 mg, IV infusion, daily, up to 10 days. |
| BG001 | RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg | Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion, daily, up to 10 days. |
| BG002 | RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg | Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion, daily, up to 10 days. |
| BG003 | RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg | Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion, daily, up to 10 days. |
| BG004 | RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg | Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion, daily, up to 10 days. |
| BG005 | RDV, Cohort 6: Age 0 to < 14 Days of Age, Gestational Age > 37 Weeks, and Birth Weight ≥ 2.5 kg | Participants received RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV infusion, daily, up to 10 days. |
| BG006 | RDV, Cohort 7: Age 0 to < 56 Days of Age, Gestational Age ≤ 37 Weeks, and Birth Weight ≥ 1.5 kg | Participants received RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV infusion, daily, up to 10 days. |
| BG007 | RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg | Participants received RDV 200 mg, IV infusion on Day 1 followed by RDV 100 mg, IV infusion, daily, up to 10 days. |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Data for Cohorts 6 and 7 are not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups. | Count of Participants | Participants | No |
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| Sex: Female, Male | Data for Cohorts 6 and 7 are not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups. | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Data for Cohorts 6 and 7 are not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups. | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Data for Cohorts 6 and 7 are not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups. | Count of Participants | Participants | No |
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| Region of Enrollment | Data for Cohorts 6 and 7 are not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups. | Number | participants |
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| Number of Participants With Clinical Status (7-Point Ordinal Scale) Score | The 7-point ordinal scale is an assessment of the clinical status of participant at a given study day:1. Death;2.Hospitalized,on invasive mechanical ventilation or extracorporeal membrane oxygenation(ECMO);3.Hospitalized, on noninvasive ventilation or high-flow oxygen devices;4.Hospitalized,requiring low-flow supplemental oxygen;5.Hospitalized,not requiring supplemental oxygen - requiring ongoing medical care(COVID-19 related or otherwise);6.Hospitalized,not requiring supplemental oxygen - no longer requiring ongoing medical care(other than per-protocol RDV administration);7.Not hospitalized. | Data for Cohorts 6 and 7 are not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups. | Count of Participants | Participants | No |
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| Oxygen Support Status | Oxygen support status was derived from the 7-point ordinal scale, 1 = death; 2 = invasive mechanical ventilation; 3 = high flow oxygen; 4 = low flow oxygen; 5 or 6 = room air; 7 = discharge. Participants with Baseline oxygen status for scores: 2 'invasive mechanical ventilation'; 3 'High Flow Oxygen'; 4 'Low Flow Oxygen', and 5 or 6 'Room Air' are reported. | Participants with oxygen support status were analyzed. Data for Cohorts 6 and 7 are not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups. | Count of Participants | Participants | No |
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| Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Ribonucleic Acid (RNA) Viral Load | The assessment were done for the samples: nasal/oropharyngeal (OP), nasopharyngeal (NP)/oropharyngeal (OP), endotracheal (ET) tube aspirates, and rectal/fecal swabs. | Participants with data available for the specific category were analyzed. Data for Cohorts 6 and 7 are not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups. | Mean | Standard Deviation | log10 copies per mL |
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| Pediatric Early Warning Score (PEWS) Scale Score | Behavior:0=playing;appropriate;1=sleeping;2=irritable;3=lethargic;confused;reduced response to pain. Cardiovascular:0=normal;pink;capillary refill(cr)1-2 seconds(secs);1=Tachycardia< 20 above normal for age;2=Tachycardia 20-29 above normal for age;gray;cr=4 secs;3=Tachycardia >=30 above/bradycardia >=10 below normal for age;Gray;cr>=5 secs.Respiratory:0=Normal;1=Respiratory rate(rr)>10 above normal using accessory muscles;30+%fraction of inspired oxygen(FiO2)/3+L/min;2= rr>20 above normal and retractions;40%FiO2 or 6+L/min;3 =rr>=5 below normal with retractions and grunting;50%FiO2/8+L/min. | Data for Cohorts 6 and 7 are not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups. | Count of Participants | Participants | No |
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| 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 With Treatment-Emergent Adverse Events (TEAEs) | TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and/or any AEs leading to premature discontinuation of study drug. | Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug. Data for Cohorts 6 and 7 were not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups. | Posted | Number | percentage of participants | From first dose date (Day 1) up to follow-up assessment (maximum duration: 30 days) |
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| Primary | Percentage of Participants With Treatment-Emergent Graded Laboratory Abnormalities | Treatment-emergent graded laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any time post baseline up to and including the date of last dose of study drug plus 30 days. The laboratory abnormalities were graded using division of allergy and infectious diseases (DAIDS) scale. DAIDS scale is used to grade the severity of adult and pediatric unwanted medical events. Grade 1: mild event, Grade 2: moderate event, Grade: serious event, Grade 4: potentially life-threatening event. | Participants in the Safety Analysis Set with at least 1 postbaseline value for the test under evaluation were analyzed. Data for Cohorts 6 and 7 were not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups. | Posted | Number | percentage of participants | From first dose date (Day 1) up to follow-up assessment (maximum duration: 30 days) |
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| Primary | Pharmacokinetic (PK) Parameter: Cmax of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State | Cmax is defined as maximum plasma concentration of drug. Plasma concentrations were drawn as follows: (1) for Cohorts 1-4 and 8 on Day 2 and Day 3 with Day 5 as optional; (2) for Cohorts 5-7 on Day 2 or Day 3. | The RDV and Metabolites PK Analysis Set included all enrolled participants who received at least 1 dose of RDV and for whom PK concentrations of RDV and metabolites were available. Data for Cohorts 6 and 7 were not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups. | Posted | Mean | Standard Deviation | ng/mL | Day 2: end of infusion and 4 hours post end of infusion, Day 3: pre-infusion and 2 hours post end of infusion, and Day 5: middle of infusion and 6 hours post end of infusion; infusion duration: 30 minutes to 2 hours |
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| Primary | PK Parameter: AUCtau of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State | AUCtau is defined as area under the concentration versus time curve over the dosing interval. Plasma concentrations were drawn as follows: (1) for Cohorts 1-4 and 8 on Day 2 and Day 3 with Day 5 as optional; (2) for Cohorts 5-7 on Day 2 or Day 3. | The RDV and Metabolites PK Analysis Set included all enrolled participants who received at least 1 dose of RDV and for whom PK concentrations of RDV and metabolites were available. Data for Cohorts 6 and 7 were not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups. | Posted | Mean | Standard Deviation | h*ng/mL | Day 2: end of infusion and 4 hours post end of infusion, Day 3: pre-infusion and 2 hours post end of infusion, and Day 5: middle of infusion and 6 hours post end of infusion; infusion duration: 30 minutes to 2 hours |
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| Secondary | Percentage of Participants With Clinical Improvement on a 7-point Ordinal Scale Score | Clinical improvement was defined as ≥ 1-point and ≥ 2-point improvement from Baseline clinical status or recovery or discharged alive on 7-point ordinal scale. Recovery was defined as an improvement from a Baseline score of 2 - 5 to a score of 6 or 7 or an improvement from a Baseline score of 6 to 7 on the ordinal scale. The ordinal scale was used for the assessment of the clinical status at a given day using a 7-point ordinal scale with an increasing score indicating improvement. Scale: 1=Death, 2=Hospitalized, on invasive mechanical ventilation or ECMO, 3=Hospitalized, on non-invasive ventilation or high flow oxygen devices, 4=Hospitalized, requiring low flow supplemental oxygen, 5=Hospitalized, not requiring supplemental oxygen-requiring ongoing medical care COVID-19 related or otherwise), 6=Hospitalized, not requiring supplemental oxygen-no longer required ongoing medical care (other than RDV administration), 7=Not hospitalized. The 95% CI was based on the Clopper-Pearson method. | The Full Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug. Data for Cohorts 6 and 7 were not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 10 |
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| Secondary | Time (Days) to Discharge From Hospital | Time to discharge was the duration from the first dose date to getting discharged from the hospital. | The participants in the Full Analysis Set who were discharged alive on or prior to Day 30 were analyzed. Data for Cohorts 6 and 7 are not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups. | Posted | Median | Inter-Quartile Range | days | From first dose date (Day 1) up to follow-up assessment (maximum duration: 30 days) |
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| Secondary | Number of Participants With Change From Baseline in Oxygenation Use | Oxygen support status was derived from the 7-point ordinal scale score, 1 = death; 2 = invasive mechanical ventilation; 3 = high flow oxygen; 4 = low flow oxygen; 5 or 6 = room air; 7 = discharge. Change from Baseline for participants with oxygenation use status as '3=High Flow Oxygen', '4=Low Flow Oxygen' and '5=Room Air' at Baseline. | Participants in Full Analysis Set with Oxygenation use status as 'High Flow Oxygen', 'Low Flow Oxygen' and 'Room Air' at Baseline were analyzed. Number analyzed are participants applicable for the specific categories. Data for Cohorts 6 and 7 were not reported due to participants' confidentiality reasons as there were only 1 participant in each of these groups. | Posted | Count of Participants | Participants | No | Day 10 |
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| Secondary | Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) | Mechanical ventilation status was derived from the 7-point ordinal scale score, 1 = death; 2 = invasive mechanical ventilation; 3 = high flow oxygen; 4 = low flow oxygen; 5 or 6 = room air; 7 = discharge. | Participants in Full Analysis Set with Oxygenation use status as 'Mechanical Ventilation or ECMO' at Baseline were analyzed. Data for Cohorts 6 and 7 were not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups. | Posted | Count of Participants | Participants | Day 10 |
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| Secondary | Days to First Confirmed Negative Polymerase Chain Reaction (PCR) Result | Confirmed negative PCR is defined by as 2 consecutive negative PCR results or negative result at the last available sample for participants who completed or discontinued from the study. The assessment were done for the samples: nasal/oropharyngeal (OP), nasopharyngeal (NP)/oropharyngeal (OP), endotracheal (ET) aspirates, and rectal/fecal swabs. | The Full Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug. Data for Cohorts 6 and 7 are not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups. | Posted | Median | Inter-Quartile Range | days | From first dose date (Day 1) up to follow-up assessment (maximum duration: 30 days) |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load Up to Day 10 or Up to the First Confirmed Negative PCR Result | Change from baseline in SARS-CoV-2 viral load up to Day 10 or up to the first negative PCR result with confirmation (whichever comes first) were reported. The assessment were done for the samples: nasal/oropharyngeal (OP) samples, nasopharyngeal (NP)/OP samples, endotracheal (ET) aspirates, and rectal/fecal swabs. | The Full Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug. Number analyzed are participants with data available for analysis for the specific category. Data for Cohorts 6 and 7 are not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups. | Posted | Mean | Standard Deviation | log10 copies per mL | Baseline, Day 10, and Day of Discharge (Day 10 or before) |
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| Secondary | Bilirubin Concentrations in < 14-day-old Participants | Data for Cohorts 6 and 7 were not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups. | Posted | From first dose date (Day 1) up to follow-up assessment (maximum duration: 30 days) |
|
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| Secondary | Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale | The PEWS was measured by 3 components, where 1= behavior, 2= perfusion assessed by capillary refill and heart rate, and 3= respiratory status assessed by respiratory rate, effort, and oxygen requirement. The score ranged between 0 to 9 point, with higher score representing the highest severity level. A negative change from baseline value indicated an improvement. Data are reported for participants with a PEWS behavior score ≥ 2 at baseline, and a ≥ 2-point improvement (indicated by a decrease) in PEWS behavior score by Day 10, participants with a PEWS behavior score ≥ 1 at baseline, with ≥ 1-point improvement in PEWS behavior score by Day 10 and participants who recovered in PEWS behavior, defined as a Baseline score of 1 through 3 improved to a score of 0. | The Full Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug. Number analyzed are participants with data available for analysis for the specific category. Data for Cohorts 6 and 7 were not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 10 |
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| Secondary | Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD) | Plasma concentrations were drawn as follows: (1) for Cohorts 1-4 and 8 on Day 2 and Day 3, with Day 5 as optional; (2) for Cohorts 5-7 on Day 2 or Day 3. | The SBECD PK Analysis Set included all participants who were enrolled and received at least 1 dose of RDV and for whom PK concentrations of SBECD were available. Data for Cohorts 6 and 7 were not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups. | Posted | Mean | Standard Deviation | ug/mL | Day 2: end of infusion and 4 hours post end of infusion, Day 3: pre-infusion and 2 hours post end of infusion, and Day 5: middle of infusion and 6 hours post end of infusion; infusion duration: 30 minutes to 2 hours |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Concomitant Use of Medications Other Than RDV for Treatment of COVID-19 | Participants who received at least one concomitant non-study COVID-19 medication from the first day of RDV treatment through the 30-day Follow-up visit or early withdrawal are reported. | The Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug. Data for Cohorts 6 and 7 were not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups. | Posted | Number | percentage of participants | first dose date (Day 1) up to follow-up assessment (maximum duration: 30 days) |
|
All-Cause Mortality: First dose date up to approximately 8 weeks Adverse events: From first dose date (Day 1) up to follow-up assessment (maximum duration: 30 days)
All-cause mortality: All Enrolled Analysis Set will include all participants who are enrolled into the study.
Adverse events: Safety Analysis Set included all enrolled participants who received at least one dose of study drug. Data for Cohorts 6 and 7 are not reported due to participants' confidentiality reasons as there was only 1 participant in each of these groups.
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 | Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg | Participants received RDV 200 mg, intravenous (IV) infusion on Day 1 followed by RDV 100 mg, IV infusion daily up to 10 days. | 2 | 12 | 5 | 12 | 11 | 12 |
| EG001 | RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg | Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. | 1 | 12 | 2 | 12 | 7 | 12 |
| EG002 | RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg | Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. | 0 | 12 | 0 | 12 | 9 | 12 |
| EG003 | RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg. | Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. | 0 | 12 | 3 | 12 | 7 | 12 |
| EG004 | RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg | Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. | 0 | 4 | 1 | 3 | 2 | 3 |
| EG005 | RDV, Cohort 6: Age 0 to < 14 Days of Age, Gestational Age > 37 Weeks, and Birth Weight ≥ 2.5 kg | Participants received RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV infusion daily up to 10 days. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG006 | RDV, Cohort 7: Age 0 to < 56 Days of Age, Gestational Age ≤ 37 Weeks, and Birth Weight ≥ 1.5 kg | Participants received RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV infusion daily up to 10 days. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG007 | RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg | Participants received RDV 200 mg, IV infusion on Day 1 followed by RDV 100 mg, IV infusion daily up to 10 days. | 1 | 5 | 1 | 5 | 4 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastrointestinal necrosis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumoperitoneum | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Enterococcal bacteraemia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Negative pressure pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haemodynamic instability | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cardiomegaly | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Coronary artery dilatation | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Extrasystoles | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Ventricular septal defect | Congenital, familial and genetic disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Anal pruritus | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Inflammation | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Infusion site extravasation | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Physical deconditioning | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Bacterial disease carrier | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Fungal cystitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia cytomegaloviral | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pseudomonal bacteraemia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Bacterial test positive | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood calcium decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood glucose decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood magnesium decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood sodium increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Breath sounds abnormal | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Calcium ionised decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Electrocardiogram ST segment elevation | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Oxygen saturation abnormal | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Vitamin C decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Abnormal loss of weight | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vitamin K deficiency | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chest wall haematoma | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Device leakage | Product Issues | MedDRA 26.0 | Systematic Assessment |
| |
| Device occlusion | Product Issues | MedDRA 26.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Lung opacity | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 26.0 | 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 | May 22, 2023 | Oct 4, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000606551 | remdesivir |
Not provided
Not provided
Not provided
|
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| United Kingdom |
|
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| Italy |
|
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| Spain |
|
|
|
|
|
| Nasopharyngeal/oropharyngeal Swabs |
|
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| Endotracheal Tube Aspirates |
|
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| Rectal/fecal Swabs |
|
|
|
| Cardiovascular |
|
|
| Respiratory |
|
|
| OG002 | RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg | Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. |
| OG003 | RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg | Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. |
| OG004 | RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg | Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. |
| OG005 | RDV, Cohort 6: Age 0 to < 14 Days of Age, Gestational Age > 37 Weeks, and Birth Weight ≥ 2.5 kg | Participants received RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV infusion daily up to 10 days. |
| OG006 | RDV, Cohort 7: Age 0 to < 56 Days of Age, Gestational Age ≤ 37 Weeks, and Birth Weight ≥ 1.5 kg | Participants received RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV infusion daily up to 10 days. |
| OG007 | RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg | Participants received RDV 200 mg, IV infusion on Day 1 followed by RDV 100 mg, IV infusion daily up to 10 days. |
|
|
| RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg |
Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. |
| OG003 | RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg | Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. |
| OG004 | RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg | Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. |
| OG005 | RDV, Cohort 6: Age 0 to < 14 Days of Age, Gestational Age > 37 Weeks, and Birth Weight ≥ 2.5 kg | Participants received RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV infusion daily up to 10 days. |
| OG006 | RDV, Cohort 7: Age 0 to < 56 Days of Age, Gestational Age ≤ 37 Weeks, and Birth Weight ≥ 1.5 kg | Participants received RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV infusion daily up to 10 days. |
| OG007 | RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg | Participants received RDV 200 mg, IV infusion on Day 1 followed by RDV 100 mg, IV infusion daily up to 10 days. |
|
|
| RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg |
Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. |
| OG003 | RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg | Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. |
| OG004 | RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg | Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. |
| OG005 | RDV, Cohort 6: Age 0 to < 14 Days of Age, Gestational Age > 37 Weeks, and Birth Weight ≥ 2.5 kg | Participants received RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV infusion daily up to 10 days. |
| OG006 | RDV, Cohort 7: Age 0 to < 56 Days of Age, Gestational Age ≤ 37 Weeks, and Birth Weight ≥ 1.5 kg | Participants received RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV infusion daily up to 10 days. |
| OG007 | RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg | Participants received RDV 200 mg, IV infusion on Day 1 followed by RDV 100 mg, IV infusion daily up to 10 days. |
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| OG001 |
| RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg |
Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. |
| OG002 | RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg | Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. |
| OG003 | RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg | Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. |
| OG004 | RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg | Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. |
| OG005 | RDV, Cohort 6: Age 0 to < 14 Days of Age, Gestational Age > 37 Weeks, and Birth Weight ≥ 2.5 kg | Participants received RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV infusion daily up to 10 days. |
| OG006 | RDV, Cohort 7: Age 0 to < 56 Days of Age, Gestational Age ≤ 37 Weeks, and Birth Weight ≥ 1.5 kg | Participants received RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV infusion daily up to 10 days. |
| OG007 | RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg | Participants received RDV 200 mg, IV infusion on Day 1 followed by RDV 100 mg, IV infusion daily up to 10 days. |
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| OG003 |
| RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg |
Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. |
| OG004 | RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg | Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. |
| OG005 | RDV, Cohort 6: Age 0 to < 14 Days of Age, Gestational Age > 37 Weeks, and Birth Weight ≥ 2.5 kg | Participants received RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV infusion daily up to 10 days. |
| OG006 | RDV, Cohort 7: Age 0 to < 56 Days of Age, Gestational Age ≤ 37 Weeks, and Birth Weight ≥ 1.5 kg | Participants received RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV infusion daily up to 10 days. |
| OG007 | RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg | Participants received RDV 200 mg, intravenous (IV) infusion on Day 1 followed by RDV 100 mg, IV infusion daily up to 10 days. |
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Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. |
| OG003 | RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg | Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. |
| OG004 | RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg | Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion, daily, up to 10 days. |
| OG005 | RDV, Cohort 6: Age 0 to < 14 Days of Age, Gestational Age > 37 Weeks, and Birth Weight ≥ 2.5 kg | Participants received RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV infusion daily up to 10 days. |
| OG006 | RDV, Cohort 7: Age 0 to < 56 Days of Age, Gestational Age ≤ 37 Weeks, and Birth Weight ≥ 1.5 kg | Participants received RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV infusion daily up to 10 days. |
| OG007 | RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg | Participants received RDV 200 mg, IV infusion on Day 1 followed by RDV 100 mg, IV infusion daily up to 10 days. |
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| OG003 | RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg | Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. |
| OG004 | RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg | Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. |
| OG005 | RDV, Cohort 6: Age 0 to < 14 Days of Age, Gestational Age > 37 Weeks, and Birth Weight ≥ 2.5 kg | Participants received RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV infusion daily up to 10 days. |
| OG006 | RDV, Cohort 7: Age 0 to < 56 Days of Age, Gestational Age ≤ 37 Weeks, and Birth Weight ≥ 1.5 kg | Participants received RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV infusion daily up to 10 days. |
| OG007 | RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg | Participants received RDV 200 mg, intravenous (IV) infusion on Day 1 followed by RDV 100 mg, IV infusion daily up to 10 days. |
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Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. |
| OG003 | RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg | Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. |
| OG004 | RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg | Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. |
| OG005 | RDV, Cohort 6: Age 0 to < 14 Days of Age, Gestational Age > 37 Weeks, and Birth Weight ≥ 2.5 kg | Participants received RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV infusion daily up to 10 days. |
| OG006 | RDV, Cohort 7: Age 0 to < 56 Days of Age, Gestational Age ≤ 37 Weeks, and Birth Weight ≥ 1.5 kg | Participants received RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV infusion daily up to 10 days. |
| OG007 | RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg | Participants received RDV 200 mg, IV infusion on Day 1 followed by RDV 100 mg, IV infusion daily up to 10 days. |
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| OG002 |
| RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg |
Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. |
| OG003 | RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg | Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. |
| OG004 | RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg | Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. |
| OG005 | RDV, Cohort 6: Age 0 to < 14 Days of Age, Gestational Age > 37 Weeks, and Birth Weight ≥ 2.5 kg | Participants received RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV infusion daily up to 10 days. |
| OG006 | RDV, Cohort 7: Age 0 to < 56 Days of Age, Gestational Age ≤ 37 Weeks, and Birth Weight ≥ 1.5 kg | Participants received RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV infusion daily up to 10 days. |
| OG007 | RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg | Participants received RDV 200 mg, IV infusion on Day 1 followed by RDV 100 mg, IV infusion daily up to 10 days. |
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Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. |
| OG002 | RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg | Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. |
| OG003 | RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg | Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. |
| OG004 | RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg | Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. |
| OG005 | RDV, Cohort 6: Age 0 to < 14 Days of Age, Gestational Age > 37 Weeks, and Birth Weight ≥ 2.5 kg | Participants received RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV infusion daily up to 10 days. |
| OG006 | RDV, Cohort 7: Age 0 to < 56 Days of Age, Gestational Age ≤ 37 Weeks, and Birth Weight ≥ 1.5 kg | Participants received RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV infusion daily up to 10 days. |
| OG007 | RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg | Participants received RDV 200 mg, IV infusion on Day 1 followed by RDV 100 mg, IV infusion daily up to 10 days. |
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Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. |
| OG003 | RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg | Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. |
| OG004 | RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg | Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. |
| OG005 | RDV, Cohort 6: Age 0 to < 14 Days of Age, Gestational Age > 37 Weeks, and Birth Weight ≥ 2.5 kg | Participants received RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV infusion daily up to 10 days. |
| OG006 | RDV, Cohort 7: Age 0 to < 56 Days of Age, Gestational Age ≤ 37 Weeks, and Birth Weight ≥ 1.5 kg | Participants received RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV infusion daily up to 10 days. |
| OG007 | RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg | Participants received RDV 200 mg, IV infusion on Day 1 followed by RDV 100 mg, IV infusion daily up to 10 days. |
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| OG003 | RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg | Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. |
| OG004 | RDV,Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg | Participants received RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion daily up to 10 days. |
| OG005 | RDV, Cohort 6: Age 0 to < 14 Days of Age, Gestational Age > 37 Weeks, and Birth Weight ≥ 2.5 kg | Participants received RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV infusion daily up to 10 days. |
| OG006 | RDV, Cohort 7: Age 0 to < 56 Days of Age, Gestational Age ≤ 37 Weeks, and Birth Weight ≥ 1.5 kg | Participants received RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV infusion daily up to 10 days. |
| OG007 | RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg | Participants received RDV 200 mg, IV infusion on Day 1 followed by RDV 100 mg, IV infusion daily up to 10 days. |
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| Score: 1 |
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| Score: 2 |
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| Score: 3 |
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| Score: 1 |
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| Score: 2 |
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| Score: 3 |
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