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Paxlovid in the treatment of COVID-19

Paxlovid in the treatment of COVID-19

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12428408
Enrollment
58
Registered
2023-03-18
Start date
2022-11-15
Completion date
Unknown
Last updated
2023-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 (SARS-CoV-2 infection) Infections and Infestations

Interventions

58 cases infected with the Omicron variant of COVID-19 were retrospectively collected and divided into two groups according to the treatment regimen. Patients in both groups were given Lianhua Qingwen

Sponsors

Wenzhou Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Confirmation of COVID-19 infection within 24 h and positive nasopharyngeal swab for COVID-19 nucleic acid RNA 2. Age =12 years and weight =40 kg 3. Subjects of fertility must agree to use highly effective contraceptive methods

Exclusion criteria

Exclusion criteria: 1. Previous history of COVID-19 treatment 2. A known history of active liver disease 3. Patients on renal dialysis or have moderate to severe impaired renal function 4. The known human immunodeficiency virus (HIV) infection 5. Suspected or confirmed concurrent active systemic infections other than COVID-19 infection 6. Allergy or other contraindication to any component of the study intervention 7. Any drug or substance that is currently or expected to be used that is a high reliance on CYP3A4 enzyme clearance or strong CYP3A4 enzyme inducers 8. Pregnant or breastfeeding women

Design outcomes

Primary

MeasureTime frame
CT values (CT values of 40 for negative results) of nasal swab COVID-19 nucleic acid tests on days 4, 7, 9 and 11 of treatment

Secondary

MeasureTime frame
1. First negative conversion time (or CT value =40) of COVID-19 nucleic acid tests 2. Hospitalization time, strictly according to discharge criteria 3. Adverse drug reactions recorded during hospitalization 4. COVID-19 nucleic acid re-positive in daily COVID-19 nucleic acid tests in the 7 days of isolation after discharge

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026