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OPtimisation of antiviral Therapy in Immunocompromised COVID-19 patients: a randomized factorial controlled strategy trial: the OPTICOV Study
EU CTIS ID: 2022-501408-81-01
What this study is testing
The primary objective is to assess whether (iii) a combination antiviral therapy of two DAAs (nirmatrelvir/r + remdesivir∞) (iv) an increase in nirmatrelvir duration from 5 to 10 days improves viral efficacy by decreasing the SARS-CoV-2 positivity rate by real time RT-PCR (CT<32) in nasopharyngeal swabs at D10.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Laboratory confirmed SARS-CoV-2 infection by RT-PCR
- Asymptomatic or mild to moderate COVID-19 (WHO progression scale ≤5)
- ≥ 16 years of age (for patients recruited in Italy and in Norway, ≥ 18 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)
You likely can't join if
- 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
See the full eligibility criteria
- Laboratory confirmed SARS-CoV-2 infection by RT-PCR
- Asymptomatic or mild to moderate COVID-19 (WHO progression scale ≤5)
- ≥ 16 years of age (for patients recruited in Italy and in Norway, ≥ 18 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) or holders of health insurance (LAF for participants recruited in Norway)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.