Antiviral Therapy for Immunocompromised COVID-19 Patients
OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients
Recruiting
Phase 2Interventional Study
COVID-19Immunodeficiency
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
16 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
256 (estimated)
Sponsor
Calmy Alexandra · Other
Who this trial is looking for
This trial is looking for people with confirmed COVID-19 who have weakened immune systems. Participants will receive either a combination of antiviral treatments or a single antiviral treatment and may have their treatment duration adjusted.
Are You a Good Fit for This Trial?
You may be able to join if
I have a confirmed COVID-19 infection.
I am 16 years or older.
I have mild to moderate COVID-19.
I have a weakened immune system.
I can follow the study rules.
I have health insurance.
I agree to sign consent forms.
You may not be able to join if
I have a high viral load from COVID-19.
I am allergic to any study drugs.
I weigh less than 40 kg.
My liver function tests are very high.
I have serious liver disease.
I am currently participating in another clinical trial.
I have received antiviral treatments in the last 14 days, except for specific recent doses.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 C…
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).
Trial Locations
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City
State
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Status
Eligibility Criteria
Inclusion Criteria:
1. Laboratory confirmed SARS-CoV-2 infection by real time RT-PCR or positive antigenic test (commercialized assay)
2. 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)…
Inclusion Criteria:
1. Laboratory confirmed SARS-CoV-2 infection by real time RT-PCR or positive antigenic test (commercialized assay)
2. 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).
3. ≥ 16 years of age;
4. 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 immunosuppression criteria such as:
* 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, 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
5. Willing and able to comply with study requirements and restrictions as described in the informed consent form (ICF)
6. 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.
7. Participant's or its legal representative's signature of the informed consent form
Exclusion Criteria:
1. SARS-CoV-2 PCR ≥30 CT at screening
2. Hypersensitivity to study drugs (active substance(s) or excipients)
3. Body weight \< 40 kg
4. AST (Aspartate transaminase) and/or alanine transaminase (ALT) \> 5 times the upper limit
5. Cirrhosis Child-Pugh score C
6. Is taking or is anticipated to require any prohibited therapies\*.
7. Participation in another interventional 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 days after the inclusion. Investigators of the different clinical studies should agree on participant's inclusion.
8. 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
9. 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.
10. Pregnant or breastfeeding female
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