OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients: a Randomized Factorial Controlled Strategy Trial: the OPTICOV Study
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.
• Laboratory confirmed SARS-CoV-2 infection by RT-PCR or positive antigenic test
• Asymptomatic or mild to moderate COVID-19 (WHO progression scale \<5). Patients receiving oxygen therapy for reasons other than a pulmonary COVID-19 are eligible)
• ≥ 16 years of age;
• Immunocompromised as defined by ≥ 1 risk factors for severe COVID-19 as assessed by the FOPH list (criteria 5: diseases/treatments leading to immune suppression)
‣ Severe immunosuppression (e.g., HIV infection with CD4 + T cell count \<350 / µl)
⁃ Neutropenia (\<1000 neutrophils / µl) ≥1 week
⁃ Lymphocytopenia (\<200 lymphocytes/µl)
⁃ Hereditary immunodeficiencies
⁃ Intake of drugs which suppress the immune system (e.g. glucocorticoids for a long time \[an equivalent dose of prednisone \>20 mg/day \> 3 months\], monoclonal antibodies, cytostatics, biological products, everolimus, mTOR inhibitors etc.) in the last 12 months
⁃ Active cancer under cytostatics or targeted therapy known to be immunosuppressive (e.g., platinum salts, cyclophosphamide, anthracyclines, taxanes, 5-fluorouracil, gemcitabine, purine inhibitors, proteasome inhibitors) or associated with hematologic toxicity (neutropenia, lymphopenia), for example sunitinib, imatinib, regorafenib
⁃ Aggressive lymphomas (all types)
⁃ Acute lymphatic leukemia
⁃ Acute myeloid leukemia
⁃ Acute promyelocytic leukemia
⁃ T prolymphocytic leukemia
⁃ Primary central nervous system lymphoma
⁃ Stem cell transplantation
⁃ Light chain amyloidosis
⁃ Chronic lymphoid leukemia
⁃ Multiple myeloma
⁃ Sickle cell disease
⁃ Bone marrow transplant
⁃ Organ transplant
⁃ Being on the waiting list for an organ transplant
• Willing and able to comply with study requirements and restrictions as described in the informed consent form (ICF)
• Enrolled in or a beneficiary of a Social Security program (State Medical Aid (AME) is not a Social Security program) or holders of health insurance
• Participant's or its legal representative's signature of the informed consent form