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

• Status: Not yet recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Public Health Clinical Center
• Collaborator: Kunming Pharmaceuticals, Inc.
• Treatments: Colchicine

Criteria

Inclusion Criteria:

1. At the time of signing ICF, the subjects were 18 to 65 years old (including 18 and 65 years old), both men and women;

2. Within 72 hours before screening, any samples confirmed by the laboratory were positive for SARS-CoV-2;

3. Clinical classification was ordinary type according to the Novel Coronavirus Pneumonia Diagnosis and Treatment Plan (Trial 8th Edition)；

4. Symptoms appeared ≤ 5 days before randomization; Such as fever, cough, shortness of breath, sore throat and diarrhea;

5. 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:

1. 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.

2. 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.

3. People who are known to be allergic to the test drug and its components;

4. People with inflammatory bowel disease, chronic diarrhea, malabsorption;

5. People with previous neuromuscular disease;

6. People with severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2);

7. 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;

8. Patients who are taking colchicine or have a history of colchicine treatment (mainly chronic prescriptions for familial Mediterranean fever or gout);

9. People who have used immunosuppressants, corticosteroids, interleukin-1 inhibitors, or interleukin-6 inhibitors within 30 days before screening;

10. People who test positive for anti-SARS-CoV-2 immunoglobulin G (IgG);

11. People who have been vaccinated against COVID-19;

12. Any comorbidities that require surgery within 7 days before screening, or life-threatening comorbidities within 30 days before screening;

13. 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);

14. Suffering from any serious concomitant systemic disease, condition or disorder that the researcher believes should be prevented from participating in this study;

15. Pregnant or lactating women who have a positive human chorionic gonadotropin (hCG) test;

16. 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;

17. Participated in other clinical studies within 30 days before screening;

18. People who have other factors that the researcher believes are not suitable for inclusion.