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Table 3 The use of remdesivir in clinical practice of the UK, Europe, and the USA

From: The use of remdesivir outside of clinical trials during the COVID-19 pandemic

The use of remdesivir in COVID-19 outside of clinical trials: compassionate use, expanded access, early scheme, and emergency use
➢ Primary objective: increase access for COVID-19 patients not eligible to be enrolled in clinical trials
➢ Secondary objective: safety
Remdesivir 100 mg available in two pharmaceutical forms:
1.Concentrate for solution for infusion
2. Powder for concentrate for solution for infusion
UK Europe USA
Informed consent No informed consent
No control group
Early access to medicines scheme Compassionate use Expanded access
NCT04323761
Treatment IND/Protocol
Expanded access
NCT04302766 Treatment IND/Protocol
Emergency use
Inclusion criteria
-Adults, adolescents, and children ≥ 12 years
-At least 40 kg
-Suspected or diagnosed COVID-19 patients requiring or not invasive ventilation and/or ECMO.
-Pregnancy—to be used with caution
-Adults, adolescents, and children ≥ 12 years
-At least 40 kg
-Suspected or diagnosed COVID-19 patients requiring or not requiring invasive ventilation and/or ECMO.
Adults, adolescents, and children ≥ 12 years
-At least 40 kg
suspected or diagnosed COVID-19 patients.
Adults, adolescents, and children
-Department of defense’s personnel
-Available for clinical follow-up for duration of the treatment and follow-up reports.
-Adults, adolescents, and children from 0 year old
-At least 3.5 kg
-suspected or diagnosed COVID-19 patients requiring or not invasive ventilation and/or ECMO.
-Pregnancy—to be used with caution
Exclusion criteria
-Children < 12
-ALT ≥ 5 ULN;
-eGFR < 30;
-Hypersensitivity
-Children < 12
-ALT ≥ 5 ULN;
-eGFR < 30;
-Hypersensivity
-Multi-organ failure;
-Use of more than 1 pressor shock
-Hypersensivity
-Pregnancy
-Children < 12
-ALT > 5 ULN
-ALT > 3 and bilirubin > 2 ULN
-eGFR < 30;
-Multiorgan failure;
-Use of more than 1 pressor shock
-Hypersensivity
-Pregnancy
-Patients requiring venous-arterial ECMO (v-a)
ALT, AST ≥ 5 ULN;
-eGFR < 30;
-Hypersensivity;
-Concomitant antiviral therapy (Kaltera)
-Anticipated transfer to another hospital that is not a study site within 72 h.
-Pregnancy
-ALT ≥ 5 ULN;-eGFR < 30;
-Hypersensitivity
Dosage and dosing regimen
-200 mg on day 1
-100 mg starting on day 2
-200 mg on day 1
-100 mg starting on day 2
NA NA Adults
-200 mg on day 1
-100 mg starting on day 2
Pediatric patients
100 mg, only powder for concentrate for solution for infusion
-5 mg/kg on day 1
-2.5 mg/kg starting on day 2
-Patients not requiring invasive ventilation will be given remdesivir every day for a total of 5 days with possible extension to 10 days.
-Patients requiring invasive ventilation and/or on ECMO will be given remdesivir every day for a total of 10 days.
-Patients not requiring invasive ventilation will be given remdesivir every day for a total of 5 days with possible extension to 10 days.
-Patients requiring invasive ventilation and/or on ECMO will be given remdesivir every day for a total of 10 days.
NA -Patients not requiring invasive ventilation will be given remdesivir every day for a total of 5 days with possible extension to 10 days.
-Patients requiring invasive ventilation and/or on ECMO will be given remdesivir every day for a total of 10 days.
  1. When no data were published in the relevant database, the NA choice was used. Since in COVID-19 breastfeeding was not recommended and should be stopped due to the lack of adequate and controlled clinical evidence, we did not include this choice either in the inclusion or in exclusion criteria. ULN-upper limit normal. The expanded access NCT04323761/Treatment IND/Protocol has 268 locations located in the USA, Europe, Australia, Israel, and Canada and to date, it is still active