NCT05642910

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
540

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 18, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 8, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

December 8, 2022

Status Verified

December 1, 2022

Enrollment Period

4 months

First QC Date

December 7, 2022

Last Update Submit

December 7, 2022

Conditions

SARS-CoV-2 Infection

Keywords

SARS-CoV-2antivirusCOVID-19

Outcome Measures

Primary Outcomes (1)

  • the proportion of patients RT-PCR negative for SARS-CoV-2 at 7 days

    the proportion of patients RT-PCR negative for SARS-CoV-2 at 7 days

    7 days after enrolled

Secondary Outcomes (2)

  • the proportion of patients RT-PCR negative for SARS-CoV-2 at 14 days

    14 days

  • the time to conversion from a positive RT-PCR test to 2 continuously negative test

    14 days

Study Arms (2)

Azvudine group

EXPERIMENTAL

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

Drug: Azvudine

Paxlovid group

ACTIVE COMPARATOR

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

Drug: Paxlovid group

Interventions

AzvudineDRUG

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

Also known as: treatment group
Azvudine group
Paxlovid groupDRUG

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

Also known as: control group
Paxlovid group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hohhot First Hospital

Hohhot, Inner Mongolia, 010031, China

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

azvudineControl Groups

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Songqiao Liu, MD. PhD.

    Southeast university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Songqiao Liu, MD. PhD.

CONTACT

086-13770723635liusongqiao@ymail.com

Junjing Zhang, MD. PhD.

CONTACT

086-04175281618zhang.jj@vip.163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Open Label
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients who meet inclusion criteria will be randomized into the Azvudine group (treatment group) and Paxlovid group (control group).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD. PhD.

Study Record Dates

First Submitted

December 7, 2022

First Posted

December 8, 2022

Study Start

October 18, 2022

Primary Completion

January 31, 2023

Study Completion

April 30, 2023

Last Updated

December 8, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

We did not seek or receive approval for this data sharing from our Institutional Review Board .

Locations

CN(1)