BridgeMD
Study of Obeldesivir in Children and Adolescents With COVID-19
EU CTIS ID: 2023-503282-27-00
What this study is testing
To evaluate the plasma pharmacokinetic (PK) of Obeldesivir (ODV; GS-5245) in pediatric participants with COVID-19 To evaluate the safety and tolerability of ODV in pediatric participants with COVID-19
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participant or legal guardian willing and able to provide written informed consent prior to performing study procedures. Participants 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 (where permitted according to local law and approved nationally and by relevant IRB or IEC): a) Cohort 1: ≥ 6 years to < 18 years and weight ≥ 40 kg b) Cohort 2: ≥ 6 years to < 18 years and weight ≥ 20 kg to < 40 kg c) Cohort 3: ≥ 2 years to < 18 years and weight ≥ 12 kg to < 20 kg d) Cohort 4: ≥ 28 days to < 18 years and weight ≥ 3 kg to < 12 kg e) Cohort 5: ≥ 14 days to < 28 days of age, GA ≥ 37 weeks and weight ≥ 2.5 kg f) Cohort 6: 0 days to < 14 days of age, GA ≥ 37 weeks and birth weight ≥ 2.5 kg g) Cohort 7: 0 days to < 56 days of age, GA < 37 weeks and birth weight ≥ 1.5 kg
- SARS-CoV-2 infection confirmed by polymerase chain reaction (PCR) or an alternative molecular diagnostic assay ≤ 5 days before screening.
- Initial onset of 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, including: a) obesity (body mass index > 95th percentile for age and sex) b) diabetes c) chronic lung disease (eg, asthma, interstitial lung disease) d) cardiac disease (eg, congenital heart disease) e) immunosuppressive disease or receipt of immunosuppressive therapies resulting in moderate or severe immunocompromise f) neurologic disorders (eg, epilepsy, convulsions, cerebral palsy) g) genetic conditions (eg, trisomy and other chromosomal abnormalities) h) medical complexity, including medical-related technological dependence that is not related to COVID-19 (eg, tracheostomy, positive pressure ventilation) i) other medical conditions that are deemed to be a risk factor by the investigator
You likely can't join if
- 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 RDV, monoclonal antibodies).
- Requirement for ongoing therapy with or prior use of any prohibited medications listed in Section 5.3.1. of the protocol
- 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.
- Suspected or confirmed concurrent active systemic infection other than COVID-19 (including influenza) that may interfere with the evaluation of response to the study intervention.
- Any of the following abnormal laboratory results at screening: a. ALT ≥ 5 × ULN b. eGFR < 60 mL/min/1.73 m2 for ≥ 1 year of age c. Serum creatinine: > 2.0 mg/dL for < 48 hours of life; > 2 × ULN for age for ≥ 48 hours of life to 1 year of age (refer to table on page 35 of protocol)
See the full eligibility criteria
Who can join
- Participant or legal guardian willing and able to provide written informed consent prior to performing study procedures. Participants 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 (where permitted according to local law and approved nationally and by relevant IRB or IEC): a) Cohort 1: ≥ 6 years to < 18 years and weight ≥ 40 kg b) Cohort 2: ≥ 6 years to < 18 years and weight ≥ 20 kg to < 40 kg c) Cohort 3: ≥ 2 years to < 18 years and weight ≥ 12 kg to < 20 kg d) Cohort 4: ≥ 28 days to < 18 years and weight ≥ 3 kg to < 12 kg e) Cohort 5: ≥ 14 days to < 28 days of age, GA ≥ 37 weeks and weight ≥ 2.5 kg f) Cohort 6: 0 days to < 14 days of age, GA ≥ 37 weeks and birth weight ≥ 2.5 kg g) Cohort 7: 0 days to < 56 days of age, GA < 37 weeks and birth weight ≥ 1.5 kg
- SARS-CoV-2 infection confirmed by polymerase chain reaction (PCR) or an alternative molecular diagnostic assay ≤ 5 days before screening.
- Initial onset of 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, including: a) obesity (body mass index > 95th percentile for age and sex) b) diabetes c) chronic lung disease (eg, asthma, interstitial lung disease) d) cardiac disease (eg, congenital heart disease) e) immunosuppressive disease or receipt of immunosuppressive therapies resulting in moderate or severe immunocompromise f) neurologic disorders (eg, epilepsy, convulsions, cerebral palsy) g) genetic conditions (eg, trisomy and other chromosomal abnormalities) h) medical complexity, including medical-related technological dependence that is not related to COVID-19 (eg, tracheostomy, positive pressure ventilation) i) other medical conditions that are deemed to be a risk factor by the investigator
What rules you out
- 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 RDV, monoclonal antibodies).
- Requirement for ongoing therapy with or prior use of any prohibited medications listed in Section 5.3.1. of the protocol
- 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.
- Suspected or confirmed concurrent active systemic infection other than COVID-19 (including influenza) that may interfere with the evaluation of response to the study intervention.
- Any of the following abnormal laboratory results at screening: a. ALT ≥ 5 × ULN b. eGFR < 60 mL/min/1.73 m2 for ≥ 1 year of age c. Serum creatinine: > 2.0 mg/dL for < 48 hours of life; > 2 × ULN for age for ≥ 48 hours of life to 1 year of age (refer to table on page 35 of protocol)
- Any major congenital renal anomaly for participants < 28 days of age.
- Apgar score < 5 for participants < 24 hours of age.
- Known hypersensitivity to the study drug, the metabolites, or formulation excipient.
- Positive pregnancy test prior to enrollment for female participants of childbearing potential
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.