- Randomized, open-label Phase 3 therapeutic trial
- Full treatment not mandatory if clinical improvement allowing discharge
- Amendment of the protocol on 15 March with, in particular, modification of the main judging criterion and inclusion criteria.
- Trial designed and conducted by the sponsor (Gilead Sciences - the pharmaceutical company marketing remdesivir), who also collected the data, monitored the conduct of the trial and performed the statistical analyses. The first manuscript was written by an author employed by Gilead Sciences, with contributions from all authors.
- Complete treatment for 172/200 (86%) patients in the 5-day group and 86/197 (43.7%) in the 10-day group.
- No control group without redesigning
Phase 3 randomized, open-label therapeutic trial. Multicentric (55 hospitals) and international (USA, Italy, Spain, Germany, Hong Kong, Singapore, South Korea and Taiwan) study. Inclusion between March 6 and March 26.
Exclusion criteria: patient receiving mechanical ventilation, ECMO, with evidence of multiviscular failure, biological criteria (ALT or AST > 5N, estimated Cockcroft-Gault creatinine clearance<50 mL/min) or patient receiving concomitant therapy with presumed activity against COVID-19 (within 24 hours prior to initiation of test treatment).
Non-stratified randomization with a 1:1 ratio of a 5-day intravenous (IV) remdesivir group to a 10-day IV remdesivir group. First dose of 200 mg and then a dose of 100 mg on subsequent days.
Primary endpoint: clinical status at D14, assessed on a 7-point ordinal scale (1: deceased; 2: invasive mechanical ventilation or ECMO; 3: non-invasive ventilation or intense oxygen therapy; 4: mild oxygen therapy; 5: not requiring oxygen but receiving continuous medical care (Covid-19 or non-Covid-19 related); 6: inpatient, not requiring supplemental oxygen or continuous medical care (other than as specified in the remitting protocol); 7: non-hospitalized).
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