The Efficacy of Azvudine and Paxlovid in High-risk Patients With COVID-19: A Prospective Randomized Controlled Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

540 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-18

Study Completion Date

2023-04-30

Brief Summary

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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).

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Detailed Description

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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).

Conditions

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SARS-CoV-2 Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients who meet inclusion criteria will be randomized into the Azvudine group (treatment group) and Paxlovid group (control group).

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Open Label

Study Groups

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Azvudine group

Patients received Azvudine orally, for 7 consecutive days (7 doses in total) .

Group Type EXPERIMENTAL

Azvudine

Intervention Type DRUG

Patients received Azvudine orally, for 7 consecutive days (7 doses in total)

Paxlovid group

Patients received Paxlovid orally for 5 consecutive days (10 doses in total).

Group Type ACTIVE_COMPARATOR

Paxlovid group

Intervention Type DRUG

Patients received Paxlovid orally for 5 consecutive days (10 doses in total).

Interventions

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Azvudine

Patients received Azvudine orally, for 7 consecutive days (7 doses in total)

Intervention Type DRUG

Paxlovid group

Patients received Paxlovid orally for 5 consecutive days (10 doses in total).

Intervention Type DRUG

Other Intervention Names

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treatment group control group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No