OPtimisation of antiviral Therapy in Immunocompromised COVID-19 patients: a randomized factorial controlled strategy trial: the OPTICOV Study - ANRS0176s OPTICOV

Inserm0 sites353 target enrollmentAugust 26, 2022

Overview

No summary available.

Registry

who.int

Start Date

August 26, 2022

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Laboratory confirmed SARS\-CoV\-2 infection by RT\-PCR, Asymptomatic or mild to moderate COVID\-19 (WHO progression scale \=5\), \= 16 years of age;, Body weight \> 40 kg, Immunocompromised as defined by \= 1 risk factors for severe COVID\-19 as assessed by the Swiss Federal Office of Public Health (FOPH) list (criteria 5: diseases/treatments leading to immune suppression) ? HIV Infection with CD4 count\< 200 cells/µL ? Neutropenia (\<1000 neutrophils / µl) \=1 week ? Lymphocytopenia (\<200 lymphocytes/µl) ? Hereditary immunodeficiencies ? Intake of drugs which suppress the immune system (e.g., taking glucocorticoids for a long time \[an equivalent dose of prednisone \>20 mg/day \> 3 months], monoclonal antibodies, cytostatics, biological products, etc. in the last 12 months) ? Aggressive lymphomas (all types) ? Acute 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), Participant’s or its legal representative's signature of the informed consent form (ICF)

•SARS\-CoV\-2 PCR \=30 CT at screening, Hypersensitivity to study drugs (active substance(s) or excipients), Creatinine clearance \<30ml/mn/.73m² (CKD\-EPI), AST or ALT \> 5 times the upper limit, Is taking or is anticipated to require any prohibited therapies, Participation in another interventional clinical study through Day 28 with an investigational compound or device, including COVID\-19 therapeutics, Presence of any condition for which, in the opinion of the investigator, participation would not be in participant’s best interest or that could prevent, limit, or confound the protocol\-specified assessments, Having received antiviral treatments against SARS\-CoV\-2 in the 14 days before the inclusion, Pregnant or breastfeeding female, unless additional data are available for the use of the study drugs in this population