Paxlovid in the Treatment of COVID-19 Patients With Uremia

Sponsor

Ruijin Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05386433

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Uremia	Drug: Paxlovid Drug: standard-of-care	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Effect of Paxlovid in the Treatment of COVID-19 Patients With Uremia

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: standard-of-care Standard-of-care of COVID-19 includes oxygen inhalation, antibiotics, traditional medicine, etc.	Drug: standard-of-care standard-of-care of COVID-19
Experimental: standard-of-care plus Paxlovid standard-of-care of COVID-19 plus Paxlovid	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

Arm

Intervention/Treatment

Placebo Comparator: standard-of-care

Standard-of-care of COVID-19 includes oxygen inhalation, antibiotics, traditional medicine, etc.

Drug: standard-of-care

standard-of-care of COVID-19

Experimental: standard-of-care plus Paxlovid

standard-of-care of COVID-19 plus Paxlovid

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

Outcome Measures

Primary Outcome Measures

time of negative conversion of SARS-CoV-2 nucleic acid [up to 60 days]
Time from first positive to negative of SARS-CoV-2 nucleic acid
Proportion of ICU transfer or disease progression to severe or critical illness [up to 60 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Sign informed consent. Age ≥ 18 years old. COVID-19 (nucleic acid test positive) was diagnosed before randomization. At least 1 symptom or sign of COVID-19 at the time of being enrolled into the study(symptoms and signs related to COVID-19 including cough, expectoration, dyspnea, fever, chills, fatigue, muscle soreness, diarrhea, headache, sore throat, stuffy nose, runny nose, etc.).

Exclusion Criteria:

History of active liver disease, including chronic or active hepatitis B or C, primary biliary cirrhosis, Child-Pugh B or C, or acute liver failure.

HIV infection and the viral load is greater than 400 copies/ml. Suspected or confirmed active systemic infections that may have an impact on the study evaluation except for COVID-19.

Acute heart failure, respiratory failure, severe chronic kidney disease, and cardiovascular disease caused by uremia-related complications.

Allergic to any ingredients of Paxlovid.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ruijin Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jieming QU, PhD, Ruijin Hospital

ClinicalTrials.gov Identifier:

NCT05386433

Other Study ID Numbers:

PaxlovidUremia

First Posted:

May 23, 2022

Last Update Posted:

May 23, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

COVID-19

Uremia

Study Results

No Results Posted as of May 23, 2022