COVID-19NCT05675761
The Efficacy and Safety of Azovudine in the Treatment of COVID-19
An observational study of COVID-19 and Infections, run by Fuzhou General Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Infections, Morality
- What is being tested?
- Azorubine
- Type of treatment
- Pill or oral medicine
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2023to 31 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with novel coronavirus infection meeting the criteria of The New Coronavirus Pneumonia Diagnosis and Treatment Program (Ninth Edition)
Who may be able to join
- Over 18 years old;
- 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;
- 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.);
- Participants who meet one or more of the following requirements: from the first COVID-19 symptom to the first medication ≤ 5 days;
- Agree to observe contraceptive measures during the clinical trial;
- Participants who understand and agree to follow the planned research procedures;
- Provide follow-up information during the study;
- Understand the study and be willing to sign the informed consent form.
Who cannot join
- Those who are known to be allergic to any component of the intervention preparation used in the test;
- 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);
- Patients with a known history of liver disease (cirrhosis with ChildPugh grade B and C);
- Congestive heart failure within 6 months (NYHA ¾ Grade), patients with untreated symptomatic arrhythmia or myocardial infarction history;
- Individuals with malabsorption syndrome or other diseases affecting gastrointestinal absorption, and patients who need intravenous nutrition or cannot take orally or through nasogastric tube;
- Participants who have received other SARS CoV-2 monoclonal antibody therapy or antiviral therapy (including research therapy);
Show all 13Show fewer
- Participants who received COVID-19 convalescent plasma therapy;
- Patients receiving anti HIV treatment;
- Participants who also participate in any other type of medical research or are considered to be scientifically or medically incompatible with this research;
- 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.
- Researchers believe that the test will endanger any health and safety of participants;
- 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;
- Unable to provide informed consent.Contacts and Locations.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The 900th Hospital of the Joint Logistic Support Force, PLA
Fuzhou, Fujian, 350000
zongyang yu, Ph.D, 13509327806 ext. 22859650, yuzy527@sina.com
About this study
Official title: 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.
Read the detailed description
- To evaluate the clinical efficacy of Azovudine in the treatment of mild, moderate and severe COVID-19.
- To explore the safety and adverse reactions of Azovudine in the whole population of COVID-19.
- To explore the remission time of clinical symptoms, signs and images of patients with COVID-19 treated with Azovudine.
- Explore the clinical guiding value of CORMB score.
- Conditions
- COVID-19, Infections, Morality, Death, Assisted
- Being tested
- Azorubine
- Medical subject headings
- COVID-19, Infections, Suicide, Assisted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzorubineDrug
Also called basic treatment
Azovudine tablets, 1mg /tablet, 5 tablets, QD+basic treatment (14 days at most)
| Study group | Role | What they receive |
|---|---|---|
| Combined bacterial and fungal infection | Combined bacterial and fungal infection Receives: Drug: Azorubine | |
| No bacterial and fungal infection | No bacterial and fungal infection Receives: Drug: Azorubine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1 to 28 days
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
Measured: Up to 28 days
Secondary outcomes (1)
Evaluation of positive rate
nucleic acid and /or antigen retest is positive within 28 days after negative conversion of nucleic acid and /or antigen
Measured: Day 1 to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start4 Jan 2023
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fuzhou General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- zongyang yu, Ph.D, Principal investigator, The 900th Hospital of the Joint Logistic Support Force, PLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675761
- Sponsor's protocol ID
- Innovation-A
- Status last verified
- Jan 2023
- First submitted
- 4 Jan 2023
- Last updated
- 10 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Real World Study to Evaluate the Efficacy and Safety of Azovudine in the Treatment of COVID-19
- ClinicalTrials.gov ID
- NCT05675761
- Acronym / sponsor ID
- Innovation-A
- Conditions
- COVID-19, Infections, Morality, Death, Assisted
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Fuzhou General HospitalUniversity, hospital or other
- Study start
- 4 Jan 2023 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 9 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- To evaluate the clinical efficacy of Azovudine in the treatment of mild, moderate and severe COVID-19.
- To explore the safety and adverse reactions of Azovudine in the whole population of COVID-19.
- To explore the remission time of clinical symptoms, signs and images of patients with COVID-19 treated with Azovudine.
- Explore the clinical guiding value of CORMB score.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined bacterial and fungal infection | – | Drug: AzorubineCombined bacterial and fungal infection |
| No bacterial and fungal infection | – | Drug: AzorubineNo bacterial and fungal infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with novel coronavirus infection meeting the criteria of The New Coronavirus Pneumonia Diagnosis and Treatment Program (Ninth Edition)
Key inclusion criteria (8 listed)
- Over 18 years old;
- 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;
- 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.);
- Participants who meet one or more of the following requirements: from the first COVID-19 symptom to the first medication ≤ 5 days;
- Agree to observe contraceptive measures during the clinical trial;
Key exclusion criteria (13 listed)
- Those who are known to be allergic to any component of the intervention preparation used in the test;
- 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);
- Patients with a known history of liver disease (cirrhosis with ChildPugh grade B and C);
- Congestive heart failure within 6 months (NYHA ¾ Grade), patients with untreated symptomatic arrhythmia or myocardial infarction history;
- Individuals with malabsorption syndrome or other diseases affecting gastrointestinal absorption, and patients who need intravenous nutrition or cannot take orally or through nasogastric tube;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzorubineAlso: basic treatmentAzovudine tablets, 1mg /tablet, 5 tablets, QD+basic treatment (14 days at most) | Drug | Combined bacterial and fungal infection, No bacterial and fungal infection |
Primary outcome
Continuous recovery time of clinical symptoms of Azovudine in the treatment of COVID-19
Time frame: Day 1 to 28 days
Continuous recovery time of clinical symptoms of Azovudine in the treatment of COVID-19
Safety evaluation results: for example, AE (adverse events) and SAE (serious adverse events) up to the 28th day
Time frame: Up to 28 days
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
1 secondary outcome
Evaluation of positive rate
Time frame: Day 1 to 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
zongyang yu, Ph.D principal investigator
The 900th Hospital of the Joint Logistic Support Force, PLA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Infections, run by Fuzhou General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zongyang Yu, Ph.D (13509327806 ext. 22859650, yuzy527@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous recovery time of clinical symptoms of Azovudine in the treatment of COVID-19 (time frame: Day 1 to 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.