Phase 2/3 study of Remdesivir in patients from birth to <18 years old with COVID-19

Phase 1

• Conditions: Coronavirus disease 2019 (COVID-19); MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001803-17-IT
• Lead Sponsor: GILEAD SCIENCES INCORPORATED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-10
• Last Update Posted: 26 October 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

1) Willing and able to provide assent or a parent or legal guardian willing and able to provide written informed consent (participants < 18 years of age, where locally and nationally approved) prior to performing study procedures.
2) 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]).
a) Cohort 1: = 12 years to < 18 years of age and weight at screening = 40 kg
b) Cohorts 2-4: = 28 days to < 18 years of age and weight at screening =3 kg and < 40 kg
c) Cohort 5: = 14 days to <28 days of age, gestational age > 37 weeks and weight at screening = 2.5 kg
d) Cohort 6: 0 days to < 14 days of age, gestational age > 37 weeks and birth weight of = 2.5 kg
e) Cohort 7: 0 days to < 56 days of age, gestational age = 37 weeks and birth weight of = 1.5 kg
3) SARS-CoV-2 infection confirmed by PCR
4) Hospitalized and requiring medical care for COVID-19
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Concurrent treatment with other agents with actual or possible direct antiviral activity against SARS-CoV-2 < 24 hours prior to study drug dosing
2) ALT or AST > 5 X ULN
3) eGFR < 30 mL/min using Schwartz formula for participants = 1 year of age
4)Creatinine above thresholds as described in (see table in Page 27) Protocol for < 1 year of age
5) If < 28 days of age, any major congenital renal anomaly
6) If < 24 hours of age, Apgar score < 5 at 10 minutes
7) Known hypersensitivity to the study drug, the metabolites, or formulation excipient

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified