OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients

ConditionsCOVID-19 Immunodeficiency

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age16+

SponsorCalmy Alexandra

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Paxlovid 5 days
Drug
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 10 days
Drug
Nirmatrelvir/r 300mg/100 mg bid will be given for 10 days, orally.

Treatment groups

256 Participants

are divided into 4 treatment groups

Group A: Nirmatrelvir/ritonavir (nirmatrelvir/r) 5 days aloneOther 1 intervention

Group B: Nirmatrelvir/ritonavir (nirmatrelvir/r) 10 days aloneExperimental treatment 1 intervention

Group C: Nirmatrelvir/ritonavir (nirmatrelvir/r) 5 days + remdesivir single doseExperimental treatment 1 intervention

Group D: Nirmatrelvir/ritonavir (nirmatrelvir/r) 10 days + remdesivir single doseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Day 10

Secondary outcomes

Virological

Percentage of patients with SARS-CoV-2 viral load \<32 CT by real-time RT-PCR in nasopharyngeal swabs at D5, D14 and D21 after treatment initiation

Time frame

Day 5, Day 14, Day 21

Virological

Percentage of patients with detectable SARS-CoV-2 viremia at D5, D10 and D14

Time frame

Day 5, Day 10, Day 14

Virological

Decrease of SARS-CoV-2 viral load measured by copies/ml by nasopharyngeal swab at D5, D10, D14, D21 and at D5, D10 and D14 in blood samples comparatively to screening

Time frame

Day 5, Day 10, Day 14, Day 21

Virological

Number of de novo mutations after sequencing on nasopharyngeal swabs at D5, D10, D14 and D21 comparatively to screening

Time frame

Day 5, Day 10, Day 14, Day 21

Other outcomes

Treatment discontinuation outcome because of AE or SAE

Percentage of participants with an adverse event (AE) or serious adverse event (SAE) or AE leading to treatment discontinuation up to D90

Time frame

Day 90

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Calmy Alexandra

Lead sponsor

University Hospital, Geneva

Sponsor institution

ANRS, Emerging Infectious Diseases

Collaborator

Source ClinicalTrials.gov

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