Clinical trial NCT05675761: The Efficacy and Safety of Azovudine in the Treatment of COVID-19
Official title: A Prospective, Multicenter, Real World Study to Evaluate the Efficacy and Safety of Azovudine in the Treatment of COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Infections
Morality
Death, Assisted
Lead sponsor: Fuzhou General Hospital
Sponsor class: OTHER
First posted: 2023-01-09
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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)

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Continuous recovery time of clinical symptoms of Azovudine in the treatment of COVID-19
timeFrame: Day 1 to 28 days
measure: Safety evaluation results: for example, AE (adverse events) and SAE (serious adverse events) up to the 28th day
timeFrame: Up to 28 days
Secondary outcomes:
measure: Evaluation of positive rate
timeFrame: Day 1 to 28 days
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: The 900th Hospital of the Joint Logistic Support Force, PLA
state: Fujian
Study officials:
affiliation: The 900th Hospital of the Joint Logistic Support Force, PLA
name: zongyang yu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: