Study to Evaluate the Efficacy and Safety of Colchicine Tablets in Patients With COVID-19
Covid19, Colchicine
About this trial
This is an interventional treatment trial for Covid19 focused on measuring COVID-19, Colchicine Tablets, IIT Study
Eligibility Criteria
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.
Sites / Locations
- Shanghai Public Health Clinical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Colchicine group
Standard therapy group
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 for COVID-19 according to the Novel Coronavirus Pneumonia Diagnosis and Treatment Plan (Trial 8th Edition).