This is a randomized controlled clinical study on the clinical efficacy of Azvudine andPaxlovid antivirus therapy in COVID-19 patients with high-risk. The objective is toexamine the effect of high-risk on the time for COVID-19 patients to achieve 2continuously negative SARS-CoV-2 nucleic acid test result, and the RT-PCR negativeconversion rates in day 7. Patients who meet inclusion criteria will be randomized intothe Azvudine group (treatment group) and Paxlovid group (control group).
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).
Drug: Azvudine
Patients received Azvudine orally, for 7 consecutive days (7 doses in total)
Other Name: treatment group
Drug: Paxlovid group
Patients received Paxlovid orally for 5 consecutive days (10 doses in total).
Other Name: control group
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
Hohhot First Hospital
Hohhot, Inner Mongolia, China
Investigator: Junjing Zhang, Dr
Contact: 086-04175281618
zhang.jj@vip.163.com
Songqiao Liu, MD. PhD.
086-13770723635
liusongqiao@ymail.com
Junjing Zhang, MD. PhD.
086-04175281618
zhang.jj@vip.163.com
Songqiao Liu, MD. PhD., Principal Investigator
Southeast university