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

Status: Recruiting
Location: See all (4) 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 direct antiviral agents (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 (commercialized assay)

• 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) or other immunosuppression criteria such as:

‣ Severe immunosuppression (e.g., HIV infection with CD4 + T cell count \<350 / μl)

⁃ Neutropenia (\<1000 neutrophils / μl) ≥1 week

⁃ Lymphocytopenia (\<200 lymphocytes/μl)

⁃ On dialysis treatment

⁃ 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
Switzerland
Basel University Hospital
RECRUITING
Basel
Hôpitaux Universitaires de Genève
RECRUITING
Geneva
CHUV
RECRUITING
Lausanne
University Hospital Zurich
RECRUITING
Zurich
Contact Information
Primary
Alexandra Calmy, MD PhD
alexandra.calmy@hug.ch
+41 22 372 98 12
Backup
Chiara Fedeli, PhD
chiara.fedeli@hug.ch
+41 (0)22 372 9817
Time Frame
Start Date: 2023-04-27
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 256
Treatments
Other: Nirmatrelvir/r 5 days alone
Nirmatrelvir/r 300mg/100 mg bid will be given for 5 days, orally. Nirmatrelvir/r is a combination of two molecules: nirmatrelvir which is a protease inhibitor (against 3CL) and ritonavir which has a booster role. Nirmatrelvir/r (marketed by Pfizer under the brand name Paxlovid®) is indicated for the treatment of COVID-19 in adults who do not require supplemental oxygen and who are at increased risk for progressing to severe COVID-19. Paxlovid for 5 days is the standard of care.
Experimental: Nirmatrelvir/r 10 days alone
Intervention Nirmatrelvir/r 300mg/100 mg bid will be given for 10 days, orally.
Experimental: Nirmatrelvir/r 5 days + remdesivir single dose
Nirmatrelvir/r 300mg/100 mg bid will be given for 5 days, orally. Nirmatrelvir/r is a combination of two molecules: nirmatrelvir which is a protease inhibitor (against 3CL) and ritonavir which has a booster role. Nirmatrelvir/r (marketed by Pfizer under the brand name Paxlovid®) is indicated for the treatment of COVID-19 in adults who do not require supplemental oxygen and who are at increased risk for progressing to severe COVID-19. Remdesivir flash, 200mg, intravenous. Remdesivir (marketed by Gilead under de brand name Veklury®) is indicated in patients with pneumonia requiring supplemental oxygen (inpatients), as well as in outpatients who are at increased risk of progressing to severe COVID-19. The mode of action characterize remdesivir as a direct-acting antiviral compound.
Experimental: Nirmatrelvir/r 10 days + remdesivir single dose
Nirmatrelvir/r 300mg/100 mg bid will be given for 10 days, orally. Remdesivir flash, 200mg, intravenous. Remdesivir (marketed by Gilead under de brand name Veklury®) is indicated in patients with pneumonia requiring supplemental oxygen (inpatients), as well as in outpatients who are at increased risk of progressing to severe COVID-19. The mode of action characterize remdesivir as a direct-acting antiviral compound.
Related Therapeutic Areas
Sponsors
Leads: Calmy Alexandra
Collaborators: ANRS, Emerging Infectious Diseases

This content was sourced from clinicaltrials.gov

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