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| Name | Class |
|---|---|
| Kunming Pharmaceuticals, Inc. | INDUSTRY |
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This study is designed for single-center, randomized, open label, standard therapy controlled. 60 COVID-19 subjects with a treatment period of 10 days and follow-up until 28 days after enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colchicine group | Experimental | The colchicine treatment includes an initial dose of 1 mg (1 mg and 0.5 mg two hours after), followed by 0.5 mg every 12 hours during the next 6 days and 0.5 mg every 24 hours until the completion of 10 days of total treatment. + standard therapy for COVID-19 according to the Novel Coronavirus Pneumonia Diagnosis and Treatment Plan (Trial 8th Edition). |
|
| Standard therapy group | Placebo Comparator | Standard therapy for COVID-19 according to the Novel Coronavirus Pneumonia Diagnosis and Treatment Plan (Trial 8th Edition). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine Tablets | Drug | Colchicine Tablets (Each tablet contains colchicine 0.5mg) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery rate of clinical symptoms (fever, cough, expectoration, chest tightness, shortness of breath, dyspnea) and virus negative conversion rate (RT-PCR) at day 7 | Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the patients' clinical status through the WHO Clinical Progression Scale (scores 0-10) at day 7 | The scale provides a measure of illness severity across a range from 0 (not infected) to 10 (dead) | Day 7 |
| Changes in the patients' clinical status through the WHO Clinical Progression Scale (scores 0-10) at day 10 |
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Inclusion Criteria:
Exclusion Criteria:
Severe type patients who comply with any of the following:
Critical type patients who comply with any of the following:
People who are known to be allergic to the test drug and its components;
People with inflammatory bowel disease, chronic diarrhea, malabsorption;
People with previous neuromuscular disease;
People with severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2);
People with medical history of liver cirrhosis, active chronic hepatitis, or severe liver disease with serum GOT or GPT 3 times higher than the normal upper limit;
Patients who are taking colchicine or have a history of colchicine treatment (mainly chronic prescriptions for familial Mediterranean fever or gout);
People who have used immunosuppressants, corticosteroids, interleukin-1 inhibitors, or interleukin-6 inhibitors within 30 days before screening;
People who test positive for anti-SARS-CoV-2 immunoglobulin G (IgG);
People who have been vaccinated against COVID-19;
Any comorbidities that require surgery within 7 days before screening, or life-threatening comorbidities within 30 days before screening;
Suffering from malignant tumor diseases (excluding malignant tumors that have been cured and have not recurred in the past 5 years, completely resected basal cell and squamous cell skin cancers, and any type of cancer in situ that has been completely resected);
Suffering from any serious concomitant systemic disease, condition or disorder that the researcher believes should be prevented from participating in this study;
Pregnant or lactating women who have a positive human chorionic gonadotropin (hCG) test;
People who have a fertility plan or do not consent to effective non-drug contraception during the signing of the ICF to 6 months after the end of the trial;
Participated in other clinical studies within 30 days before screening;
People who have other factors that the researcher believes are not suitable for inclusion.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongzhou Lu, Ph.D | Contact | +86-021-37990333 | 3222 | luhongzhou@fudan.edu.cn |
| Hongzhou Lu, PI | Contact | +86-021-37990333 | 3222 | luhongzhou@fudan.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hongzhou Lu, PI | Shanghai Public Health Clinical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Public Health Clinical Center | Shanghai | Shanghai Municipality | 201508 | China |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
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| Standard therapy |
| Drug |
Standard therapy for COVID-19 according to the Novel Coronavirus Pneumonia Diagnosis and Treatment Plan (Trial 8th Edition) |
|
The scale provides a measure of illness severity across a range from 0 (not infected) to 10 (dead) |
| Day 10 |
| Ventilator usage rate, usage time at day 7 | Day 7 |
| Ventilator usage rate, usage time at day 10 | Day 10 |
| Recovery rate and virus negative conversion rate (RT-PCR) of 10-day clinical symptoms (fever, cough, sputum expectoration, chest tightness, shortness of breath, dyspnea) | Day 10 |
| Time for the virus negative conversion (RT-PCR) | Up to day 28 |
| Time for observation in hospital | Up to day 28 |
| Length of hospital stay | Up to day 28 |
| Number of days in the intensive care unit | Up to day 28 |
| Changes in inflammatory markers at day 7: C-reactive protein | Day 7 |
| Changes in inflammatory markers at day 10: C-reactive protein | Day 10 |
| Changes in inflammatory markers at day 7: TNF-alfa | Day 7 |
| Changes in inflammatory markers at day 10: TNF-alfa | Day 10 |
| Changes in inflammatory markers at day 7: IL-6 | Day 7 |
| Changes in inflammatory markers at day 10: IL-6 | Day 10 |
| Changes in inflammatory markers at day 7: IL-1β | Day 7 |
| Changes in inflammatory markers at day 10: IL-1β | Day 10 |
| Changes in severity markers at day 7: D-dimer | Day 7 |
| Changes in severity markers at day 10: D-dimer | Day 10 |
| Changes in myocardial damage at day 7: hs-cTn | Day 7 |
| Changes in myocardial damage at day 10: hs-cTn | Day 10 |
| Changes in myocardial damage at day 7: NT-proBNP | Day 7 |
| Changes in myocardial damage at day 10: NT-proBNP | Day 10 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |