Official Title
A Prospective Multicenter, Randomized, Controlled Clinical Trial of the Safety and Efficacy of Azvudine vs. Nirmatrelvir-Ritonavir in Hospitalized Patients With Moderate to Severe COVID-19 Infection
Brief Summary

The COVID-19 pandemic has become a major public health challenge, and the treatmentoptions for the disease are currently limited. The commonly used oral small-moleculeanti-COVID-19 drugs in China are Nirmatrelvir-Ritonavir and Azvudine. These drugs havebeen tested in pre-marketing clinical trials in patients with non-severe COVID-19infection and have demonstrated therapeutic effects in inhibiting virus transmission andpreventing disease progression. However, until now, the efficacy and safety of thesedrugs in patients with moderate to severe COVID-19 infections remains unclear. Therefore,this study is aiming to compare the efficacy and safety of Azvudine andNirmatrelvir-Ritonavir in moderate to severe COVID-19 infections. This study will be amulticenter, randomized, controlled clinical trial study in patients hospitalized withmoderate to severe COVID-19 infections. Recovery of clinical symptoms, nucleic acidnegative conversion, improvement in oxygenation index, and imaging improvement will beused as study endpoints.

Detailed Description

Not Provided

Unknown status
COVID-19

Drug: Azvudine

5mg orally, once a day, for no more than 14 days

Drug: Nirmatrelvir-Ritonavir

Nirmatrelvir 300mg combined with Ritonavir 100mg every 12 hours for 5 days. For patients
with 30≤ eGFR < 60 ml/min, it should be reduced to150mg/100mg Nirmatrelvir-Ritonavir
every 12 hours for 5 days

Eligibility Criteria

Inclusion Criteria:

1. Hospitalized patients of ≥18 years old, regardless of gender or race;

2. Patients who have a positive SARS-CoV-2 test result;

3. Diagnosed with moderate or severe COVID-19 infection according to the diagnostic
criteria from the "Diagnosis and treatment program trial version 10 guidelines"
issued by the National Health Commission of the People's Republic of China.
Including:

①Moderate: continuous high fever for more than 3 days or/and cough, shortness of
breath, etc., but the breathing frequency (RR) is less than 30 times/minute, and the
oxygen saturation when inhaling air at rest is > 93%. Imaging shows the
characteristic manifestations of COVID-19 pneumonia.

② Severe: Adults meet any of the following requirements: A, shortness of breath, RR≥
30 times/minute; B, the oxygen saturation when inhaling air at rest is ≤ 93%; C,
Arterial partial oxygen pressure (PaO2)/ Fraction of inspiration O2 (FiO2) ≤300mmHg
(1mmHg=0.133kPa), and PaO2/FiO2 should be corrected according to the following
formula for areas above 1000 m :PaO2/FiO2× [760/ atmospheric pressure (mmHg)]; D,
the clinical symptoms were gradually aggravated, and the lung imaging showed that
the lesion progressed significantly within 24 ~ 48 hours > 50%.

4. Join this study voluntarily.

5. Each subject must sign an informed consent form (ICF) indicating that he/she
understands the purpose and procedure of the study and is willing to participate in
the study. Considering the patient's condition, the ICF may be signed by the legal
representative.

Exclusion Criteria:

1. Allergic to the drugs involved;

2. Pregnancy or lactation;

3. Diagnosed or suspected critical COVID-19 infection;

4. Child-Pugh C of liver function or estimated glomerular filtration rate (eGFR) less
than 30mL/min during screening;

5. Receive SARS-CoV-2 monoclonal antibody therapy or other antiviral therapy;

6. The subject and/or authorized family members refused to receive anti-COVID-19
treatment;

7. Any life-threatening disease or organ system dysfunction that the researcher thinks
can harm the safety of the subjects and expose the research results to unnecessary
risks; drug addicts, uncontrolled mental illness or cognitive dysfunction.

8. Join other similar clinical researchers within 3 months;

9. Patients who were not considered suitable for inclusion by the researchers (such as
patients who were expected to be unable to adhere to the treatment due to financial
problems).

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
China
Locations

Shandong Provincial Hospital
Jinan, Shandong, China

Contacts

Bing Leng
+86531-68776461
taozilb@163.com

Chengwu Shen
+86531-68778252
scw810@163.com

Not Provided

Shandong Provincial Hospital
NCT Number
Keywords
Covid-19
Azvudine
Nirmatrelvir-Ritonavir
Efficacy
safety
MeSH Terms
COVID-19
Ritonavir
Nirmatrelvir
Nirmatrelvir and ritonavir drug combination