Clinical trial NCT05642910: The Efficacy of Azvudine and Paxlovid in High-risk Patients With COVID-19: A Prospective Randomized Controlled Trial
Official title: The Efficacy of Azvudine and Paxlovid in High-risk Patients With COVID-19: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: SARS-CoV-2 Infection
Keywords: SARS-CoV-2
antivirus
COVID-19
Lead sponsor: Southeast University, China
Sponsor class: OTHER
Collaborators: name: Hohhot First Hospital, Hohhot, Inner Mongolia, China
First posted: 2022-12-08
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients who meet inclusion criteria will be randomized into the Azvudine group (treatment group) and Paxlovid group (control group).
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: the proportion of patients RT-PCR negative for SARS-CoV-2 at 7 days
timeFrame: 7 days after enrolled
Secondary outcomes:
measure: the proportion of patients RT-PCR negative for SARS-CoV-2 at 14 days
timeFrame: 14 days
measure: the time to conversion from a positive RT-PCR test to 2 continuously negative test
timeFrame: 14 days
Other outcomes:
Locations:
city: Hohhot
country: China
facility: Hohhot First Hospital
state: Inner Mongolia
Study officials:
affiliation: Southeast university
name: Songqiao Liu, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References: