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Paxlovid in the Treatment of COVID-19 Patients With Uremia

NCT05386433 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-05-23

No results posted yet for this study

Summary

This study is a single-center, open-label, randomized controlled clinical study to evaluate the effect of Paxlovid on the virus-negative time and disease progression in uremic patients infected with SARS-CoV-2 (omicron variants).

This study will enroll maintenance hemodialysis patients infected with SARS-CoV-2 (omicron variants).

After signing the informed consent form, the qualified subjects will be randomly stratified 1:1 to standard-of-care (SOC) or SOC plus Paxlovid for five days.

Conditions

Interventions

DRUG

Paxlovid

Paxlovid contains two medicines: nirmatrelvir and ritonavir. Nirmatrelvir \[PF-07321332\] is a SARS-CoV-2 main protease (Mpro) inhibitor (also known as SARS-CoV2 3CL protease inhibitor) that works by inhibiting viral replication in the early stages of the disease to prevent progression to severe COVID-19. Ritonavir is co-administered with nirmatrelvir to help slow its metabolism in order for it to remain active in the body for longer periods of time at higher concentrations to help combat the virus.

DRUG

standard-of-care

standard-of-care of COVID-19

Sponsors & Collaborators

  • Ruijin Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2022-07-31
Completion
2022-08-31
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05386433 on ClinicalTrials.gov