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NCT Number: NCT05813600

Efficacy and Safety of Nirmatrelvir/Ritonavir for Treating Omicron Variant of COVID-19

The goal of this clinical trial is to evaluate the efficacy and safety of Nirmatrelvir/Ritonavir in the treatment of the Omicron variant of COVID-19. The main question it aims to answer is: Whether the use of the drug can help patients recover from COVID-19.

Patients in both groups were given Lianhua Qingwen Capsule orally, 3 times/day, 6 g/time. oral antipyretic (ibuprofen suspension 10ml) and symptomatic supportive treatment for body temperature >38.5 ℃. The study group was given Nirmatrelvir 300mg/Ritonavir 100mg orally, q12h, for 5 days, and the control group not given any antiviral drugs.

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Key information

Conditions

Omicron Variant of COVID-19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xiangao Jiang

Wenzhou, Zhejiang, 325000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmation of COVID-19 infection within 24h and positive nasopharyngeal swab for COVID-19 nucleic acid RNA；
  • Age ≥12 years and weight ≥ 40Kg；
  • Subjects of fertility must agree to use highly effective contraceptive methods.

Exclusion criteria

  • Previous history of COVID-19 treatment；
  • The known history of active liver disease；
  • Patients on renal dialysis or have moderate to severe impaired renal function；
  • The known human immunodeficiency virus (HIV) infection;
  • Suspected or confirmed concurrent active systemic infections other than COVID-19 infection；
  • Allergy or other contraindication to any component of the study intervention;
  • 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；
  • pregnant or breastfeeding women.

Treatment and study plan

Nirmatrelvir/ritonavir

Drug

Patients in both groups were given Lianhua Qingwen Capsule orally, 3 times/day, 6 g/time. oral antipyretic (ibuprofen suspension 10ml) and symptomatic supportive treatment for body temperature >38.5 ℃. The study group was given Nirmatrelvir 300mg/Ritonavir 100mg orally, q12h, for 5 days, and the control group not given any antiviral drugs.

Primary outcomes

  1. Nasal swab COVID-19 nucleic acid tests

    Time frame: On days 4, 7, 9 and 11 of treatment

    Patients in both groups underwent nasal swab COVID-19 nucleic acid tests on days 4, 7, 9 and 11 of treatment, and CT values were recorded (CT values of 40 for negative results). Compare the difference in the change of CT values of COVID-19 nucleic acid between two groups of patients

  2. Virus turn negative

    Time frame: From date of randomization until the date of first documented progression, assessed up to 5 months

    Compare the first negative conversion(or CT value ≥35) time of coronavirus nucleic acid between two groups

  3. Hospital stays

    Time frame: From date of randomization until the date of first documented progression, assessed up to 5 months

    Compare the difference in hospitalization time between the two groups strictly according to discharge criteria

  4. Adverse drug reaction

    Time frame: From date of randomization until the date of first documented progression, assessed up to 5 months

    Compare the adverse drug reactions during hospitalization between two groups

  5. COVID-19 nucleic acid re-positive

    Time frame: From date of randomization until the date of first documented progression, assessed up to 5 months

    After discharge, patients in both groups continued to be isolated at the isolation point for 7 days and underwent COVID-19 nucleic acid tests daily to compare the COVID-19 nucleic acid re-positive

Sponsors and collaborators

Lead sponsor

Xiangao Jiang

Other

Registry information

Official study title

To Evaluate the Efficacy and Safety of Nirmatrelvir/Ritonavir in the Treatment of the Omicron Variant of COVID-19

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 14, 2023
Registry last updated
Apr 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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