The Efficacy of Azvudine and Paxlovid in High-risk Patients With COVID-19: A Prospective Randomized Controlled Trial
Launched by SOUTHEAST UNIVERSITY, CHINA · Dec 7, 2022
Trial Information
Current as of July 05, 2025
Unknown status
Keywords
ClinConnect Summary
This clinical trial is studying the effectiveness of two antiviral medications, Azvudine and Paxlovid, in helping high-risk patients with COVID-19 recover faster. The goal is to see how quickly patients can test negative for the virus after starting treatment. Participants will be randomly assigned to receive either Azvudine or Paxlovid, allowing researchers to compare the results from both groups.
To be eligible for this trial, participants need to be between 18 and 85 years old, diagnosed with COVID-19, and have at least one factor that puts them at higher risk for severe illness. They should also have started experiencing symptoms within the last five days. Patients who are severely ill, have certain serious health conditions, or are pregnant or breastfeeding cannot participate. Those who join the trial will need to sign a consent form and can expect to be closely monitored throughout the study to track their progress and any side effects. This trial is currently recruiting participants, and we hope it will provide valuable information to help treat high-risk COVID-19 patients more effectively.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Patients aged 18-85 years (inclusive).
- • Meet the diagnostic criteria for COVID-19.
- • At least one high risk factor for progression to severe COVID-19
- • No more than 5 days from the onset of clinical symptoms
- • Sign informed consent form.
- Exclusion Criteria:
- • Severe or critically patients with COVID-19
- • Have received neutralizing antibodies or convalescent plasma therapy due to COVID-19
- • Child-Pugh grade C or acute liver failure
- • Chronic renal failure (eGFR\<30 mL/min)
- • Grade III or IV cardiac function, or known left ventricular ejection fraction \< 30%
- • Known or suspected history of active or extrapulmonary tuberculosis
- • Patients who are allergic to the active ingredient of the drug
- • Pregnant and lactating women
About Southeast University, China
Southeast University, located in Nanjing, China, is a prestigious institution renowned for its commitment to advancing medical research and clinical innovation. With a strong emphasis on interdisciplinary collaboration, the university leverages its robust academic resources and state-of-the-art facilities to conduct clinical trials that aim to address pressing healthcare challenges. Southeast University actively engages in partnerships with healthcare organizations and industry leaders to facilitate cutting-edge research, enhance patient outcomes, and contribute to the global medical community. Through its dedicated focus on ethical standards and scientific rigor, Southeast University is poised to make significant contributions to the field of clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Hohhot, Inner Mongolia, China
Patients applied
Trial Officials
Songqiao Liu, MD. PhD.
Principal Investigator
Southeast university
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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