OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients: a Randomized Factorial Controlled Strategy Trial: the OPTICOV Study

Status: Recruiting
Location: See all (18) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Pellegrin Hospital
RECRUITING
Bordeaux
Saint-André Hospital
RECRUITING
Bordeaux
Francois Mitterrand Hospital
RECRUITING
Dijon
Croix Rousse Hospital
RECRUITING
Lyon
La Colombière Hospital
RECRUITING
Montpellier
Hotel Dieu Hospital
RECRUITING
Nantes
Bichat Claude-Bernard Hospital
RECRUITING
Paris
Laribosière Hospital
RECRUITING
Paris
Pitié-Salpêtrière Hospital
RECRUITING
Paris
Saint Antoine Hospital
RECRUITING
Paris
Saint Louis Hospital
RECRUITING
Paris
Robert Debré Hospital
RECRUITING
Reims
Purpan Hospital
RECRUITING
Toulouse
Tourcoing Hospital
RECRUITING
Tourcoing
Switzerland
Basel University Hospital
RECRUITING
Basel
University Hospitals of Geneva
RECRUITING
Geneva
University Hospital CHUV
NOT_YET_RECRUITING
Lausanne
University Hospital Zurich
RECRUITING
Zurich
Contact Information
Primary
Douae Ammour
douae.ammour@inserm.fr
+33782960531
Backup
Chiara Fedeli
chiara.fedeli@hug.ch
+41 (0)22 372 9817
Time Frame
Start Date: 2023-04-27
Estimated Completion Date: 2025-05
Participants
Target number of participants: 256
Treatments
Experimental: Nirmatrelvir/r 5 days alone
Experimental: Nirmatrelvir/r 10 days alone
Experimental: Nirmatrelvir/r 5 days + remdesivir s.d
Experimental: Nirmatrelvir/r 10 days + remdesivir s.d
Related Therapeutic Areas
Sponsors
Collaborators: University Hospital, Geneva
Leads: ANRS, Emerging Infectious Diseases

This content was sourced from clinicaltrials.gov

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