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New treatment option for COVID-19
Official title OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients
ClinicalTrials.gov ID: NCT07406217
What this study is testing
What is Paxlovid 5 days?
Paxlovid 5 days is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for covid-19.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 Coronavirus Disease 2019 (COVID-19).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 and older
You may be able to join if
- Laboratory confirmed SARS-CoV-2 infection by real time 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...
- ≥ 16 years of age;
- Immunocompromised as defined by ≥ 1 risk factors for severe COVID-19 as assessed by the Federal Office of Public Health (FOPH) list (criteria 5...
- Severe immunosuppression (e.g., human immunodeficiency virus (HIV) infection with CD4 + T cell count \<350 / μl)
You likely can't join if
- SARS-CoV-2 PCR ≥30 CT at screening
- Hypersensitivity to study drugs (active substance(s) or excipients)
- Body weight \< 40 kg
- AST (Aspartate transaminase) and/or alanine transaminase (ALT) \> 5 times the upper limit
- Cirrhosis Child-Pugh score C
- Is taking or is anticipated to require any prohibited therapies\ .
See the full eligibility criteria
- Laboratory confirmed SARS-CoV-2 infection by real time 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 Federal Office of Public Health (FOPH) list (criteria 5: diseases/treatments leading to immune suppression) or other...
- Severe immunosuppression (e.g., human immunodeficiency virus (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...
- 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)...
- 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
- SARS-CoV-2 PCR ≥30 CT at screening
- Hypersensitivity to study drugs (active substance(s) or excipients)
- Body weight \< 40 kg
- AST (Aspartate transaminase) and/or alanine transaminase (ALT) \> 5 times the upper limit
- Cirrhosis Child-Pugh score C
- Is taking or is anticipated to require any prohibited therapies\ .
- Participation in another treatment clinical study with an investigational compound or device, including COVID-19 therapeutics, where the study intervention is performed in the 28 days preceding the inclusion and the 10...
- 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 with exception of those having received one or two doses of nirmatrevir/r in the 24h preceding the inclusion in the study.
- Pregnant or breastfeeding female
The study team makes the final eligibility decision.
Where it's taking place
- Basel, Basel, Switzerland
- Geneva, Canton of Geneva, Switzerland
- Lausanne, Canton of Vaud, Switzerland
- Zurich, Canton of Zurich, 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, 16 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basel, Basel, Switzerland; Geneva, Canton of Geneva, Switzerland; Lausanne, Canton of Vaud, Switzerland; Zurich, Canton of Zurich, 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 ClinicalTrials.gov; the study team decides eligibility.