An Early Phase 1 interventional study of Paxlovid and standard-of-care in COVID-19 and Uremia, sponsored by Ruijin Hospital. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-23.
Sponsored by Ruijin Hospital · Early Phase 1, Interventional, and Treatment
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.
7,775 studies on the registry are indexed under COVID-19; 482 are open to participants now.
This study's planned enrollment of 40 is below the median of 100 across 4,175 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Ruijin Hospital is the lead sponsor of 668 studies on the registry; 377 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
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.
Standard-of-care of COVID-19 includes oxygen inhalation, antibiotics, traditional medicine, etc.
Drug: standard-of-care
standard-of-care of COVID-19 plus Paxlovid
Drug: Paxlovid · Drug: standard-of-care
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.
standard-of-care of COVID-19
time of negative conversion of SARS-CoV-2 nucleic acid
Time from first positive to negative of SARS-CoV-2 nucleic acid
Time frame: up to 60 days
Proportion of ICU transfer or disease progression to severe or critical illness
Time frame: up to 60 days
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jun 2022; primary completion for Jul 2022, 1 month later.
Of 138 non-industry phase 1 interventional studies under COVID-19, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 22. This study's planned 1 month is below that.
Counting every sponsor, half of 314 studies reached it within 8 months; a quarter within 3 and three quarters within 15.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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