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NCT05366192: SPHPS
The Safety of Paxlovid in Hemodialysis Patients With Covid-19
Phase 4 trial testing Nirmatrelvir and ritonavir stage 1 in Safety Issues in 18 participants. Completed in 8 June 2022.
6 June 2022
Quick facts
| Lead sponsor | RenJi Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 6 May 2022 |
| Primary completion | 6 June 2022 |
| Estimated completion | 8 June 2022 |
| Sites | 1 location across China |
Drugs / interventions tested
- Nirmatrelvir and ritonavir stage 1 — full drug profile →
- Nirmatrelvir and ritonavir stage 2 — full drug profile →
Conditions studied
- Safety Issues — all drugs for Safety Issues →
Sponsor
RenJi Hospital
Who can join
Adults 18 to 75, any sex, with Safety Issues. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Infection with SARS-CoV-2 continue to threaten global health. Persons with chronic kidney disease, including dialysis treatment are at hight risk for severe Covid-19 and associated adverse outcomes. Paxlovid (Nirmatrelvir/Ritonavir) decreases risk of progression to severe Covid-19. It is not recommended for dialysis patients because due to lack of data. The aim of the present study is evaluate the safety of Paxlovid in hemodialysis patients with SARS-CoV-2 infection. This is a prospective study. In stage 1 arm, 10 hemodialysis patients with SARS-COV-2 infection will be treated with nirmatrelvir 150mg qd (another 75mg will be supplied after hemodialysis treatment) and ritonavir 100mg bid everyday for 5 days. In stage 2 arm, 10 patients will be treated with nirmatrelvir 300mg qd (another 150mg will be supplied after hemodialysis treatment) and ritonavir 100 bid everyday for 5 days. The primary outcome is the number of patients whose ALT, AST or total bilirubin increase two times from baseline. The secondary outcome is the number of patients whose SARS-CoV-2 lower than 500 copies/mL.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
Oral antiviral treatments for COVID-19: opportunities and challenges.
Rahmah L, Abarikwu SO, Arero AG, Essouma M, et al · · 2022 · cited 53× · PMID 35871712 · DOI 10.1007/s43440-022-00388-7 -
Drug treatment of COVID-19 infection.
Lui G, Guaraldi G. · · 2023 · cited 27× · PMID 36917228 · DOI 10.1097/mcp.0000000000000953 -
How to use COVID-19 antiviral drugs in patients with chronic kidney disease.
Kale A, Shelke V, Dagar N, Anders HJ, et al · · 2023 · cited 14× · PMID 36843922 · DOI 10.3389/fphar.2023.1053814 -
Genetic conservation across SARS-CoV-2 non-structural proteins - Insights into possible targets for treatment of future viral outbreaks.
Kandwal S, Fayne D. · · 2023 · cited 11× · PMID 36940641 · DOI 10.1016/j.virol.2023.02.011 -
Different drug approaches to COVID-19 treatment worldwide: an update of new drugs and drugs repositioning to fight against the novel coronavirus.
Oliver JC, Silva EN, Soares LM, Scodeler GC, et al · · 2022 · cited 10× · PMID 36578829 · DOI 10.1177/25151355221144845 -
Nirmatrelvir/Ritonavir for hemodialysis patients with COVID-19.
Lu J, Cai H, Hao Y, Lin Z, et al · · 2023 · cited 3× · PMID 37251313 · DOI 10.3389/fphar.2023.1161897
Verify or expand the search:
- PubMed search for NCT05366192
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other RenJi Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05366192 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by RenJi Hospital
- Last refreshed: 14 June 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05366192.
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