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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05038449
• Other study ID #: KPC/QSXJ/01
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 6, 2021
• Est. completion date: September 1, 2023

Study information

• Verified date: September 2021
• Source: Shanghai Public Health Clinical Center
• Contact: Hongzhou Lu, Ph.D
• Phone: +86-021-37990333
• Email: luhongzhou[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colchicine
• Covid19

Intervention

Drug:
• Colchicine Tablets
Colchicine Tablets (Each tablet contains colchicine 0.5mg)
• Standard therapy
Standard therapy for COVID-19 according to the Novel Coronavirus Pneumonia Diagnosis and Treatment Plan (Trial 8th Edition)

Locations

Country	Name	City	State
China	Shanghai Public Health Clinical Center	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Public Health Clinical Center	Kunming Pharmaceuticals, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Ventilator usage rate, usage time at day 7		Day 7
Secondary	Ventilator usage rate, usage time at day 10		Day 10
Secondary	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
Secondary	Time for the virus negative conversion (RT-PCR)		Up to day 28
Secondary	Time for observation in hospital		Up to day 28
Secondary	Length of hospital stay		Up to day 28
Secondary	Number of days in the intensive care unit		Up to day 28
Secondary	Changes in inflammatory markers at day 7: C-reactive protein		Day 7
Secondary	Changes in inflammatory markers at day 10: C-reactive protein		Day 10
Secondary	Changes in inflammatory markers at day 7: TNF-alfa		Day 7
Secondary	Changes in inflammatory markers at day 10: TNF-alfa		Day 10
Secondary	Changes in inflammatory markers at day 7: IL-6		Day 7
Secondary	Changes in inflammatory markers at day 10: IL-6		Day 10
Secondary	Changes in inflammatory markers at day 7: IL-1ß		Day 7
Secondary	Changes in inflammatory markers at day 10: IL-1ß		Day 10
Secondary	Changes in severity markers at day 7: D-dimer		Day 7
Secondary	Changes in severity markers at day 10: D-dimer		Day 10
Secondary	Changes in myocardial damage at day 7: hs-cTn		Day 7
Secondary	Changes in myocardial damage at day 10: hs-cTn		Day 10
Secondary	Changes in myocardial damage at day 7: NT-proBNP		Day 7
Secondary	Changes in myocardial damage at day 10: NT-proBNP		Day 10