COVID-19
Conditions
Interventions
Remdesivir
Treatment Group 1:continued standard of care therapy together with IV RDV 200
mg on Day 1 followed by IV RDV 100mg on Days 2, 3, 4, and 5 Treatment Group
2:continued standard of care ther
Sponsors
Gilead Sciences
Eligibility
Age
12 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under ICH E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (participants * 18 years of age), or willing and able to provide assent (participants * 12 and 94% on room air or requiring supplemental oxygen at screening 6) Radiographc evidence of pulmonary infiltrates 7) Men and women of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in Protocol Appendix 3.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following exclusion criteria are not to be enrolled in this study: 1) Participation in any other clinical trial of an experimental treatment for COVID-19 2) Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 is prohibited 5xULN 6) Creatinine clearance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical status assessed by a 7-point ordinal scale on Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of participants with treatment emergent adverse events. | — |
Countries
Netherlands
Outcome results
None listed