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. | |