NCT07406217

Brief 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 Coronavirus Disease 2019 (COVID-19).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
256

participants targeted

Target at P75+ for phase_2 covid19

Timeline
Completed

Started Apr 2023

Longer than P75 for phase_2 covid19

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 27, 2023

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Completed
Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

3 years

First QC Date

February 5, 2026

Last Update Submit

February 13, 2026

Conditions

COVID-19Immunodeficiency

Keywords

COVID-19ImmunodepressionSARS-CoV-2PaxlovidVekluryViral load

Outcome Measures

Primary Outcomes (1)

  • Virological

    Percentage of patients with SARS-CoV-2 viral load \<32 cycle threshold (CT) by real-time RT-PCR in nasopharyngeal swabs at D10 after treatment initiation.

    Day 10

Secondary Outcomes (19)

  • Virological

    Day 5, Day 14, Day 21

  • Virological

    Day 5, Day 10, Day 14

  • Virological

    Day 5, Day 10, Day 14, Day 21

  • Virological

    Day 5, Day 10, Day 14, Day 21

  • Virological

    Day 5, Day 10, Day 14, Day 21

  • +14 more secondary outcomes

Other Outcomes (1)

  • Treatment discontinuation outcome because of AE or SAE

    Day 90

Study Arms (4)

Nirmatrelvir/ritonavir (nirmatrelvir/r) 5 days alone

OTHER

Nirmatrelvir/r 300mg/100 mg bis in die (twice a day, 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.

Drug: Paxlovid 5 days

Nirmatrelvir/ritonavir (nirmatrelvir/r) 10 days alone

EXPERIMENTAL

Intervention Nirmatrelvir/r 300mg/100 mg bid will be given for 10 days, orally.

Drug: Paxlovid 10 days

Nirmatrelvir/ritonavir (nirmatrelvir/r) 5 days + remdesivir single dose

EXPERIMENTAL

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.

Drug: Paxlovid 5 days

Nirmatrelvir/ritonavir (nirmatrelvir/r) 10 days + remdesivir single dose

EXPERIMENTAL

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.

Drug: Paxlovid 10 days

Interventions

Paxlovid 5 daysDRUG

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.

Nirmatrelvir/ritonavir (nirmatrelvir/r) 5 days + remdesivir single doseNirmatrelvir/ritonavir (nirmatrelvir/r) 5 days alone
Paxlovid 10 daysDRUG

Nirmatrelvir/r 300mg/100 mg bid will be given for 10 days, orally.

Nirmatrelvir/ritonavir (nirmatrelvir/r) 10 days + remdesivir single doseNirmatrelvir/ritonavir (nirmatrelvir/r) 10 days alone

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify 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 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 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
  • +13 more criteria

You may not qualify 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\*.
  • 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
  • Pregnant or breastfeeding female

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Basel University Hospital

Basel, Basel, 4031, Switzerland

RECRUITING

Hôpitaux Universitaires de Genève

Geneva, Canton of Geneva, 1205, Switzerland

RECRUITING

CHUV

Lausanne, Canton of Vaud, 10-549, Switzerland

RECRUITING

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

COVID-19Immunologic Deficiency Syndromes

Interventions

nirmatrelvir and ritonavir drug combination

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesImmune System Diseases

Study Officials

  • Alexandra Calmy, MD PhD

    Hopitaux Universitaires de Genève

    PRINCIPAL INVESTIGATOR

  • Nina Khanna, MD PhD

    Basel University Hospital

    PRINCIPAL INVESTIGATOR

  • Nicolas Muller, MD PhD

    University of Zurich

    PRINCIPAL INVESTIGATOR

  • Oriol Manuel, MD PhD

    University Hospital CHUV

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra Calmy, MD PhD

CONTACT

+41 22 372 98 12alexandra.calmy@hug.ch

Chiara Fedeli, PhD

CONTACT

+41 (0)22 372 9817chiara.fedeli@hug.ch

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

February 5, 2026

First Posted

February 12, 2026

Study Start

April 27, 2023

Primary Completion

April 10, 2026

Study Completion

June 30, 2026

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual Participant Data are described in the study protocol

Locations

CH(4)