SARS-CoV-2 Infection
Conditions
Keywords
SARS-CoV-2, antivirus, COVID-19
Brief summary
This is a randomized controlled clinical study on the clinical efficacy of Azvudine and Paxlovid antivirus therapy in COVID-19 patients with high-risk. The objective is to examine the effect of high-risk on the time for COVID-19 patients to achieve 2 continuously negative SARS-CoV-2 nucleic acid test result, and the RT-PCR negative conversion rates in day 7. Patients who meet inclusion criteria will be randomized into the Azvudine group (treatment group) and Paxlovid group (control group).
Detailed description
After enrollment, patients will be randomized into treatment or control groups. Patients received Azvudine orally, for 7 consecutive days (7 doses in total) or Paxlovid orally for 5 consecutive days (10 doses in total). The test for RT-PCR test through either nasopharyngeal or oropharyngeal swabs were conducted on a daily basis from day 3 of their hospitalization until conversion was observed. The primary outcome was the proportion of patients acheive 2 continuously RT-PCR negative for SARS-CoV-2 at 7 days following treatment initiation, including both ORF gene Ct value≥35 and N gene Ct value≥35. Secondary outcomes included 1) the proportion of patients RT-PCR negative for SARS-CoV-2 at 14 days; 2) the time to conversion from a positive RT-PCR test to 2 continuously negative test; 3) 14-day treatment failure rate (need mechanical ventilation or high-flow oxygen therapy or death).
Interventions
DRUGAzvudine
Patients received Azvudine orally, for 7 consecutive days (7 doses in total)
DRUGPaxlovid group
Patients received Paxlovid orally for 5 consecutive days (10 doses in total).
Sponsors
Hohhot First Hospital, Hohhot, Inner Mongolia, China
Southeast University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open Label
Intervention model description
Patients who meet inclusion criteria will be randomized into the Azvudine group (treatment group) and Paxlovid group (control group).
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the proportion of patients RT-PCR negative for SARS-CoV-2 at 7 days | 7 days after enrolled | the proportion of patients RT-PCR negative for SARS-CoV-2 at 7 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the proportion of patients RT-PCR negative for SARS-CoV-2 at 14 days | 14 days | the proportion of patients RT-PCR negative for SARS-CoV-2 at 14 days |
| the time to conversion from a positive RT-PCR test to 2 continuously negative test | 14 days | the time to conversion from a positive RT-PCR test to 2 continuously negative test |
Countries
China
Contacts
Primary ContactSongqiao Liu, MD. PhD.
Backup ContactJunjing Zhang, MD. PhD.
Outcome results
None listed