Study to Evaluate the Efficacy and Safety of Colchicine Tablets in Patients With COVID-19

Study Overview
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Brief Summary
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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.

Official Title
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An IIT, Randomized, Single-Center, Open-Lable, Standard Therapy Controlled Study to Evaluate the Efficacy and Safety of Colchicine Tablets in Patients With COVID-19

Conditions
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Colchicine, Covid19

Intervention / Treatment
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* Drug: Colchicine Tablets
* Drug: Standard therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At the time of signing ICF, the subjects were 18 to 65 years old (including 18 and 65 years old), both men and women; Within 72 hours before screening, any samples confirmed by the laboratory were positive for SARS-CoV-2; Clinical classification was ordinary type according to the Novel Coronavirus Pneumonia Diagnosis and Treatment Plan (Trial 8th Edition)； Symptoms appeared ≤ 5 days before randomization; Such as fever, cough, shortness of breath, sore throat and diarrhea; Subjects were able to communicate well with the investigator, and understand and comply with the requirements of this study, understand and sign the ICF. Exclusion Criteria: Severe type patients who comply with any of the following： Shortness of breath, RR ≥ 30 times/min; In the resting state, the oxygen saturation is less than or equal to 93%; Arterial oxygen partial pressure (PaO2)/oxygen inhalation concentration (FiO2) ≤ 300 mmHg (1mmHg=0.133kPa). Note: At high altitudes (above 1000 m), PaO2/FiO2 shall be corrected according to the following formula: PaO2/FiO2 × [760/atmospheric pressure (mmHg)]; Pulmonary imaging shows that patients with obvious lesion progression > 50% within 24-48 hours. Critical type patients who comply with any of the following： Respiratory failure occurs and mechanical ventilation is required; Shock; ICU monitoring and treatment are required for other organ failure. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Colchicine group<br>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). | Drug: Colchicine Tablets<br>* Colchicine Tablets (Each tablet contains colchicine 0.5mg)<br>Drug: Standard therapy<br>* Standard therapy for COVID-19 according to the Novel Coronavirus Pneumonia Diagnosis and Treatment Plan (Trial 8th Edition)<br>|
| Placebo Comparator: Standard therapy group<br>Standard therapy for COVID-19 according to the Novel Coronavirus Pneumonia Diagnosis and Treatment Plan (Trial 8th Edition). | Drug: Standard therapy<br>* Standard therapy for COVID-19 according to the Novel Coronavirus Pneumonia Diagnosis and Treatment Plan (Trial 8th Edition)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Colchicine Tablets, IIT Study