The Efficacy and Safety of Azovudine in the Treatment of COVID-19

A Prospective, Multicenter, Real World Study to Evaluate the Efficacy and Safety of Azovudine in the Treatment of COVID-19

This study is a prospective, multicenter clinical study. It is intended to discuss the efficacy of starting Azovudine treatment as early as possible for all types of patients of COVID-19, the time of remission of specific symptoms, the proportion of patients with severe diseases, oxygen and conditions, and related adverse reactions, so as to understand the efficacy and safety of Azovudine treatment in all types of COVID-19, and provide real world data support for the treatment of the majority of COVID-19 patients.

Study Overview

• Status: Recruiting
• Conditions: Infections; COVID-19; Morality; Death, Assisted
• Intervention / Treatment: Drug: Azorubine

Detailed Description

1. To evaluate the clinical efficacy of Azovudine in the treatment of mild, moderate and severe COVID-19.
2. To explore the safety and adverse reactions of Azovudine in the whole population of COVID-19.
3. To explore the remission time of clinical symptoms, signs and images of patients with COVID-19 treated with Azovudine.
4. Explore the clinical guiding value of CORMB score.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Zongyang Yu, Ph.D; Phone Number: 22859650 13509327806; Email: yuzy527@sina.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350000
      • Recruiting
      • The 900th Hospital of the Joint Logistic Support Force, PLA
      • Contact: Zongyang Yu, Ph.D; Phone Number: 22859650 13509327806; Email: yuzy527@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with novel coronavirus infection meeting the criteria of The New Coronavirus Pneumonia Diagnosis and Treatment Program (Ninth Edition)

Description

Inclusion Criteria:

1. Over 18 years old;
2. Respiratory tract samples (nasopharynx, oropharynx, lower respiratory tract [such as sputum]) collected within 96 hours before enrollment were confirmed to be SARS CoV-2 positive by RT-PCR virus molecular amplification;
3. At least one symptom or sign of COVID-19 (symptoms and signs related to COVID-19, including cough, expectoration, dyspnea, fever, chills, fatigue, muscle soreness, diarrhea, headache, sore throat, nasal congestion, runny nose, etc.);
4. Participants who meet one or more of the following requirements: from the first COVID-19 symptom to the first medication ≤ 5 days;
5. Agree to observe contraceptive measures during the clinical trial;
6. Participants who understand and agree to follow the planned research procedures;
7. Provide follow-up information during the study;
8. Understand the study and be willing to sign the informed consent form.

Exclusion Criteria:

1. Those who are known to be allergic to any component of the intervention preparation used in the test;
2. Patients with abnormal liver function test (alanine aminotransferase and /or glutamic oxaloacetic aminotransferase exceed the upper limit of normal value by 3 times, or total bilirubin exceeds the upper limit of normal value by 2 times);
3. Patients with a known history of liver disease (cirrhosis with ChildPugh grade B and C);
4. Congestive heart failure within 6 months (NYHA ¾ Grade), patients with untreated symptomatic arrhythmia or myocardial infarction history;
5. Individuals with malabsorption syndrome or other diseases affecting gastrointestinal absorption, and patients who need intravenous nutrition or cannot take orally or through nasogastric tube;
6. Participants who have received other SARS CoV-2 monoclonal antibody therapy or antiviral therapy (including research therapy);
7. Participants who received COVID-19 convalescent plasma therapy;
8. Patients receiving anti HIV treatment;
9. Participants who also participate in any other type of medical research or are considered to be scientifically or medically incompatible with this research;
10. Participants who have participated in the intervention clinical research in the past 30 days should pass 5 half lives or 30 days, whichever is longer, if the previous research intervention has a longer half life.
11. Researchers believe that the test will endanger any health and safety of participants;
12. Women who are pregnant, nursing or planning to be pregnant during the study period or men whose partners plan to be pregnant during the study period;
13. Unable to provide informed consent.Contacts and Locations.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Combined bacterial and fungal infection	Drug: Azorubine; Azovudine tablets, 1mg /tablet, 5 tablets, QD+basic treatment (14 days at most); Other Names: basic treatment
No bacterial and fungal infection	Drug: Azorubine; Azovudine tablets, 1mg /tablet, 5 tablets, QD+basic treatment (14 days at most); Other Names: basic treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety evaluation results: for example, AE (adverse events) and SAE (serious adverse events) up to the 28th day	Safety evaluation results: for example, AE (adverse events) and SAE (serious adverse events) up to the 28th dayof Novel Coronavirus Infection by the National Health Commission (Trial Version 9) The development from asymptomatic to mild/general-type The development from mild to general-type/severe type The development from general-type to severe/critical type The development from severe to critical type	Up to 28 days
Continuous recovery time of clinical symptoms of Azovudine in the treatment of COVID-19	Continuous recovery time of clinical symptoms of Azovudine in the treatment of COVID-19	Day 1 to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of positive rate	nucleic acid and /or antigen retest is positive within 28 days after negative conversion of nucleic acid and /or antigen	Day 1 to 28 days

Collaborators and Investigators

• Sponsor: Fuzhou General Hospital
• Investigators: Principal Investigator: zongyang yu, Ph.D, The 900th Hospital of the Joint Logistic Support Force, PLA

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2023
• Primary Completion (Anticipated): October 31, 2024
• Study Completion (Anticipated): October 31, 2024

Study Registration Dates

• First Submitted: January 4, 2023
• First Submitted That Met QC Criteria: January 4, 2023
• First Posted (Actual): January 9, 2023

Study Record Updates

• Last Update Posted (Estimate): January 10, 2023
• Last Update Submitted That Met QC Criteria: January 7, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Self-Injurious Behavior; Suicide; COVID-19; Suicide, Assisted
• Other Study ID Numbers: Innovation-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No