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

Shanghai Public Health Clinical Center

Status: Unknown

Conditions: Colchicine; Covid19

Treatments: Drug: Colchicine Tablets; Drug: Standard therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05038449

KPC/QSXJ/01

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups, including a placebo group

Colchicine group

Experimental group

Description:

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).

Treatment:

Drug: Colchicine Tablets

Drug: Standard therapy

Standard therapy group

Placebo Comparator group

Description:

Standard therapy for COVID-19 according to the Novel Coronavirus Pneumonia Diagnosis and Treatment Plan (Trial 8th Edition).

Treatment:

Drug: Standard therapy