COVID-19
Conditions
Brief summary
The goal of this clinical study is to learn more about the safety and tolerability of obeldesivir (ODV) in children and adolescents with coronavirus disease 2019 (COVID-19). The primary objectives are to evaluate the plasma pharmacokinetics (PK), safety and tolerability of ODV in pediatric participants with COVID-19.
Detailed description
Pediatric participants will be enrolled as follows: * Cohort 1: ≥ 6 years to \< 18 years and weight ≥ 40 kg * Cohort 2: ≥ 6 years to \< 18 years and weight ≥ 20 kg to \< 40 kg * Cohort 3: ≥ 2 years to \< 18 years and weight ≥ 12 kg to \< 20 kg * Cohort 4: ≥ 28 days to \< 18 years and weight ≥ 3 kg to \< 12 kg * Cohort 5: ≥ 14 days to \< 28 days of age, gestational age (GA) ≥ 37 weeks and weight ≥ 2.5 kg * Cohort 6: 0 days to \< 14 days of age, GA ≥ 37 weeks and birth weight ≥ 2.5 kg * Cohort 7: 0 days to \< 56 days of age, GA \< 37 weeks and birth weight ≥ 1.5 kg
Interventions
DRUGObeldesivir
Tablet administered orally with or without food
Sponsors
Gilead Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Individual or legal guardian willing and able to provide written informed consent prior to performing study procedures. Individuals will provide assent, if possible, in accordance with local requirements and investigator's discretion. * Aged \< 18 years who meet one of the following weight criteria and gestational age (GA) criteria where applicable: * Cohort 1: ≥ 6 years to \< 18 years and weight ≥ 40 kg * Cohort 2: ≥ 6 years to \< 18 years and weight ≥ 20 kg to \< 40 kg * Cohort 3: ≥ 2 years to \< 18 years and weight ≥ 12 kg to \< 20 kg * Cohort 4: ≥ 28 days to \< 18 years and weight ≥ 3 kg to \< 12 kg * Cohort 5: ≥ 14 days to \< 28 days of age, GA ≥ 37 weeks and weight ≥ 2.5 kg * Cohort 6: 0 days to \< 14 days of age, GA ≥ 37 weeks and birth weight ≥ 2.5 kg * Cohort 7: 0 days to \< 56 days of age, GA \< 37 weeks and birth weight ≥ 1.5 kg * Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR) or an alternative molecular diagnostic assay ≤ 5 days before screening. * Initial onset of coronavirus disease 2019 (COVID-19) signs/symptoms ≤ 5 days before screening with ≥ 1 sign/symptom such as fever, cough, fatigue, shortness of breath, sore throat, headache, myalgia/arthralgia present at screening. * Presence of ≥ 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness due to COVID-19 per protocol. Key
Exclusion criteria
* Anticipated access to and use of authorized or approved COVID-19 therapies during the current COVID-19 illness \< 5 days after screening (therapies including but not limited to nirmatrelvir/ritonavir, molnupiravir, intravenous remdesivir (RDV), monoclonal antibodies). * Vaccination for SARS-CoV-2 or self-reported history of SARS-CoV-2 infection \< 4 months prior to screening. * Received any approved, authorized, or investigational direct acting antiviral drug against SARS-CoV-2 for the treatment of COVID-19 \< 28 days or \< 5 half-lives, whichever is longer, before enrollment. Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Concentration of GS-441524, Metabolite of Obeldesivir (ODV) | Day 3 (5 to 8 hours postdose) and Day 5 (predose and 15 minutes, 30 minutes, 1 hour, and 4 hours postdose) | — |
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) by Day 35 | First dose date up to Day 35 | Treatment-emergent adverse events are defined as 1 or both of the following: * 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 * Any AEs leading to premature discontinuation of study drug. |
| Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities by Day 35 | First dose date up to Day 35 | Treatment-emergent laboratory abnormalities are defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug plus 30 days participants who permanently discontinued study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Palatability for Each Formulation as Measured by Questionnaire Responses Assessed by the Study Participants | Day 5 | A questionnaire was administered to participants to assess the palatability of the formulation. Palatability was assessed by questions about how the study drug tasted. |
| Acceptability for Each Formulation as Measured by Questionnaire Responses Assessed by the Study Participants | Day 5 | A questionnaire was administered to participants to assess the acceptability of the formulation. Acceptability was assessed by questions about the size of the drug and how easy it was to swallow the study drug. |
| Time to Sustained Alleviation of Targeted Coronavirus Disease 2019 (COVID-19) Symptoms by Day 35 | First dose date up to Day 35 | The time to sustained alleviation of targeted COVID-19 symptoms will be calculated as the last date on which the symptom alleviation is assessed by Day 35 minus the first dose date plus 1 day or Day 34, whichever occurs first. Symptom alleviation is defined as follows: all targeted symptoms scored moderate or severe at baseline are scored as mild or none for at least 48 consecutive hours, and all targeted symptoms scored mild or none at baseline are scored as none for at least 48 consecutive hours; the first day of the 48 consecutive hours will be considered the symptom alleviation date. Targeted symptoms include: stuffy or runny nose, sore throat, shortness of breath, cough, low energy or tiredness, muscle or body aches, headache, chills or shivering, feeling hot or feverish, and nausea. |
| Percentage of Participants With COVID-19-Related Hospitalization or All-Cause Death by Day 35 | First dose date up to Day 35 | — |
| Percentage of Participants With Concomitant Use of Medications Other Than Remdesivir (RDV) and Obeldesivir (ODV) for Treatment of COVID-19 by Day 35 | First dose date up to Day 35 | — |
| Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load at Day 5 | Baseline, Day 5 | Nasal swab samples will be used to assess SARS-CoV-2 viral load. |
| Percentage of Participants Who Require Supplemental Oxygen Support by Day 35 | First dose date up to Day 35 | Supplemental oxygen support included low flow oxygen, high flow oxygen, noninvasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled at study sites in the United States. The study was terminated early after 3 participants were enrolled. The decision to terminate the study early was not due to any safety concerns.
Participants by arm
| Arm | Count |
|---|---|
| Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg Participants received ODV tablets (350 mg twice daily) for 5 days. | 2 |
| ODV 175 mg Twice Daily, Cohort 2: ≥ 6 Years to < 18 Years and Weight ≥ 20 kg to < 40 kg Participants received ODV tablets (175 mg twice daily) for 5 days. | 1 |
| Total | 3 |
Baseline characteristics
| Characteristic | Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg | Total | ODV 175 mg Twice Daily, Cohort 2: ≥ 6 Years to < 18 Years and Weight ≥ 20 kg to < 40 kg |
|---|---|---|---|
| Age, Customized ≥ 6 years to < 18 years | 2 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 3 Participants | 1 Participants |
| Region of Enrollment United States | 2 Participants | 3 Participants | 1 Participants |
| Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load | 3.57 log10 copies/mL STANDARD_DEVIATION 0.991 | 3.84 log10 copies/mL STANDARD_DEVIATION 0.836 | 4.36 log10 copies/mL |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 1 |
| other Total, other adverse events | 0 / 2 | 0 / 1 |
| serious Total, serious adverse events | 0 / 2 | 0 / 1 |
Outcome results
Primary
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) by Day 35
Treatment-emergent adverse events are defined as 1 or both of the following: * 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 * Any AEs leading to premature discontinuation of study drug.
Time frame: First dose date up to Day 35
Population: All participants who enrolled in the study and received the study drug were included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg | Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) by Day 35 | 0 percentage of participants |
| ODV 175 mg Twice Daily, Cohort 2: ≥ 6 Years to < 18 Years and Weight ≥ 20 kg to < 40 kg | Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) by Day 35 | 0 percentage of participants |
Primary
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities by Day 35
Treatment-emergent laboratory abnormalities are defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug plus 30 days participants who permanently discontinued study drug.
Time frame: First dose date up to Day 35
Population: All participants who enrolled in the study and received the study drug were included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities by Day 35 | 0 percentage of participants |
| ODV 175 mg Twice Daily, Cohort 2: ≥ 6 Years to < 18 Years and Weight ≥ 20 kg to < 40 kg | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities by Day 35 | 0 percentage of participants |
Primary
Plasma Concentration of GS-441524, Metabolite of Obeldesivir (ODV)
Time frame: Day 3 (5 to 8 hours postdose) and Day 5 (predose and 15 minutes, 30 minutes, 1 hour, and 4 hours postdose)
Population: All participants who enrolled in the study and received the study drug were included. Participants with available data and for whom plasma concentrations of GS-441524 were available were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg | Plasma Concentration of GS-441524, Metabolite of Obeldesivir (ODV) | Day 5 (1 hour postdose) | 510 ng/mL | — |
| Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg | Plasma Concentration of GS-441524, Metabolite of Obeldesivir (ODV) | Day 5 (4 hours postdose) | 1610 ng/mL | — |
| Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg | Plasma Concentration of GS-441524, Metabolite of Obeldesivir (ODV) | Day 3 (5 to 8 hours postdose) | 1950 ng/mL | Standard Deviation 933 |
| Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg | Plasma Concentration of GS-441524, Metabolite of Obeldesivir (ODV) | Day 5 (15 minutes postdose) | 8.37 ng/mL | — |
| Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg | Plasma Concentration of GS-441524, Metabolite of Obeldesivir (ODV) | Day 5 (predose) | 79.2 ng/mL | Standard Deviation 97.3 |
| Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg | Plasma Concentration of GS-441524, Metabolite of Obeldesivir (ODV) | Day 5 (30 minutes postdose) | 14.5 ng/mL | — |
| ODV 175 mg Twice Daily, Cohort 2: ≥ 6 Years to < 18 Years and Weight ≥ 20 kg to < 40 kg | Plasma Concentration of GS-441524, Metabolite of Obeldesivir (ODV) | Day 5 (15 minutes postdose) | 209 ng/mL | — |
| ODV 175 mg Twice Daily, Cohort 2: ≥ 6 Years to < 18 Years and Weight ≥ 20 kg to < 40 kg | Plasma Concentration of GS-441524, Metabolite of Obeldesivir (ODV) | Day 5 (predose) | NA ng/mL | — |
| ODV 175 mg Twice Daily, Cohort 2: ≥ 6 Years to < 18 Years and Weight ≥ 20 kg to < 40 kg | Plasma Concentration of GS-441524, Metabolite of Obeldesivir (ODV) | Day 3 (5 to 8 hours postdose) | NA ng/mL | — |
Secondary
Acceptability for Each Formulation as Measured by Questionnaire Responses Assessed by the Study Participants
A questionnaire was administered to participants to assess the acceptability of the formulation. Acceptability was assessed by questions about the size of the drug and how easy it was to swallow the study drug.
Time frame: Day 5
Population: All participants who enrolled in the study and received the study drug were included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg | Acceptability for Each Formulation as Measured by Questionnaire Responses Assessed by the Study Participants | Easy to Swallow | 1 Participants |
| Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg | Acceptability for Each Formulation as Measured by Questionnaire Responses Assessed by the Study Participants | Size: Okay | 2 Participants |
| Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg | Acceptability for Each Formulation as Measured by Questionnaire Responses Assessed by the Study Participants | Hard to Swallow | 0 Participants |
| Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg | Acceptability for Each Formulation as Measured by Questionnaire Responses Assessed by the Study Participants | Super Easy to Swallow | 1 Participants |
| ODV 175 mg Twice Daily, Cohort 2: ≥ 6 Years to < 18 Years and Weight ≥ 20 kg to < 40 kg | Acceptability for Each Formulation as Measured by Questionnaire Responses Assessed by the Study Participants | Hard to Swallow | 1 Participants |
| ODV 175 mg Twice Daily, Cohort 2: ≥ 6 Years to < 18 Years and Weight ≥ 20 kg to < 40 kg | Acceptability for Each Formulation as Measured by Questionnaire Responses Assessed by the Study Participants | Easy to Swallow | 0 Participants |
| ODV 175 mg Twice Daily, Cohort 2: ≥ 6 Years to < 18 Years and Weight ≥ 20 kg to < 40 kg | Acceptability for Each Formulation as Measured by Questionnaire Responses Assessed by the Study Participants | Super Easy to Swallow | 0 Participants |
| ODV 175 mg Twice Daily, Cohort 2: ≥ 6 Years to < 18 Years and Weight ≥ 20 kg to < 40 kg | Acceptability for Each Formulation as Measured by Questionnaire Responses Assessed by the Study Participants | Size: Okay | 1 Participants |
Secondary
Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load at Day 5
Nasal swab samples will be used to assess SARS-CoV-2 viral load.
Time frame: Baseline, Day 5
Population: All participants who enrolled in the study and received the study drug were included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg | Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load at Day 5 | -0.61 log10 copies/mL | Standard Deviation 0.868 |
| ODV 175 mg Twice Daily, Cohort 2: ≥ 6 Years to < 18 Years and Weight ≥ 20 kg to < 40 kg | Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load at Day 5 | NA log10 copies/mL | — |
Secondary
Palatability for Each Formulation as Measured by Questionnaire Responses Assessed by the Study Participants
A questionnaire was administered to participants to assess the palatability of the formulation. Palatability was assessed by questions about how the study drug tasted.
Time frame: Day 5
Population: All participants who enrolled in the study and received the study drug were included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg | Palatability for Each Formulation as Measured by Questionnaire Responses Assessed by the Study Participants | No Taste | 1 Participants |
| Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg | Palatability for Each Formulation as Measured by Questionnaire Responses Assessed by the Study Participants | Neutral Taste (Maybe Good or Maybe Bad) | 1 Participants |
| ODV 175 mg Twice Daily, Cohort 2: ≥ 6 Years to < 18 Years and Weight ≥ 20 kg to < 40 kg | Palatability for Each Formulation as Measured by Questionnaire Responses Assessed by the Study Participants | No Taste | 0 Participants |
| ODV 175 mg Twice Daily, Cohort 2: ≥ 6 Years to < 18 Years and Weight ≥ 20 kg to < 40 kg | Palatability for Each Formulation as Measured by Questionnaire Responses Assessed by the Study Participants | Neutral Taste (Maybe Good or Maybe Bad) | 1 Participants |
Secondary
Percentage of Participants Who Require Supplemental Oxygen Support by Day 35
Supplemental oxygen support included low flow oxygen, high flow oxygen, noninvasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation.
Time frame: First dose date up to Day 35
Population: All participants who enrolled in the study and received the study drug were included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg | Percentage of Participants Who Require Supplemental Oxygen Support by Day 35 | 0 percentage of participants |
| ODV 175 mg Twice Daily, Cohort 2: ≥ 6 Years to < 18 Years and Weight ≥ 20 kg to < 40 kg | Percentage of Participants Who Require Supplemental Oxygen Support by Day 35 | 0 percentage of participants |
Secondary
Percentage of Participants With Concomitant Use of Medications Other Than Remdesivir (RDV) and Obeldesivir (ODV) for Treatment of COVID-19 by Day 35
Time frame: First dose date up to Day 35
Population: All participants who enrolled in the study and received the study drug were included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg | Percentage of Participants With Concomitant Use of Medications Other Than Remdesivir (RDV) and Obeldesivir (ODV) for Treatment of COVID-19 by Day 35 | 0 percentage of participants |
| ODV 175 mg Twice Daily, Cohort 2: ≥ 6 Years to < 18 Years and Weight ≥ 20 kg to < 40 kg | Percentage of Participants With Concomitant Use of Medications Other Than Remdesivir (RDV) and Obeldesivir (ODV) for Treatment of COVID-19 by Day 35 | 0 percentage of participants |
Secondary
Percentage of Participants With COVID-19-Related Hospitalization or All-Cause Death by Day 35
Time frame: First dose date up to Day 35
Population: All participants who enrolled in the study and received the study drug were included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg | Percentage of Participants With COVID-19-Related Hospitalization or All-Cause Death by Day 35 | 0 percentage of participants |
| ODV 175 mg Twice Daily, Cohort 2: ≥ 6 Years to < 18 Years and Weight ≥ 20 kg to < 40 kg | Percentage of Participants With COVID-19-Related Hospitalization or All-Cause Death by Day 35 | 0 percentage of participants |
Secondary
Time to Sustained Alleviation of Targeted Coronavirus Disease 2019 (COVID-19) Symptoms by Day 35
The time to sustained alleviation of targeted COVID-19 symptoms will be calculated as the last date on which the symptom alleviation is assessed by Day 35 minus the first dose date plus 1 day or Day 34, whichever occurs first. Symptom alleviation is defined as follows: all targeted symptoms scored moderate or severe at baseline are scored as mild or none for at least 48 consecutive hours, and all targeted symptoms scored mild or none at baseline are scored as none for at least 48 consecutive hours; the first day of the 48 consecutive hours will be considered the symptom alleviation date. Targeted symptoms include: stuffy or runny nose, sore throat, shortness of breath, cough, low energy or tiredness, muscle or body aches, headache, chills or shivering, feeling hot or feverish, and nausea.
Time frame: First dose date up to Day 35
Population: All participants who enrolled in the study and received the study drug were included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg | Time to Sustained Alleviation of Targeted Coronavirus Disease 2019 (COVID-19) Symptoms by Day 35 | 3.4 Days | Standard Deviation 0.47 |
| ODV 175 mg Twice Daily, Cohort 2: ≥ 6 Years to < 18 Years and Weight ≥ 20 kg to < 40 kg | Time to Sustained Alleviation of Targeted Coronavirus Disease 2019 (COVID-19) Symptoms by Day 35 | 2.5 Days | — |