drugset / Trial / NCT05587894
OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients: a Randomized Factorial Controlled Strategy Trial
RandomizedParallel-groupOpen-labelTreatment
Summary
The overall purpose of the trial is to evaluate the efficacy and safety of possible combination antiviral therapy DAA (remdesivir + nirmatrelvir/r)∞ versus the reference monotherapy (nirmatrelvir/r alone) and to assess the efficacy and safety of increasing the nirmatrelvir/r course from 5- to 10 days in immunocompromised patients diagnosed with asymptomatic or mild to moderate COVID-19.
Timeline
- Start
- 2023-04-27
- Primary completion
- 2026-06-30
- Completion
- 2027-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nirmatrelvir | Small molecule | 100 mg | Oral |
| Subject | Nirmatrelvir | Small molecule | 300 mg | Oral |
| Subject | Remdesivir | Small molecule | 200 mg | Intravenous |