Clinical trial NCT05038449: Study to Evaluate the Efficacy and Safety of Colchicine Tablets in Patients With COVID-19
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Colchicine
Keywords: COVID-19
Colchicine Tablets
IIT Study
Lead sponsor: Shanghai Public Health Clinical Center
Sponsor class: OTHER_GOV
Collaborators: name: Kunming Pharmaceuticals, Inc.
First posted: 2021-09-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Recovery rate of clinical symptoms (fever, cough, expectoration, chest tightness, shortness of breath, dyspnea) and virus negative conversion rate (RT-PCR) at day 7
timeFrame: Day 7
Secondary outcomes:
measure: Changes in the patients' clinical status through the WHO Clinical Progression Scale (scores 0-10) at day 7
timeFrame: Day 7
measure: Changes in the patients' clinical status through the WHO Clinical Progression Scale (scores 0-10) at day 10
timeFrame: Day 10
measure: Ventilator usage rate, usage time at day 7
timeFrame: Day 7
measure: Ventilator usage rate, usage time at day 10
timeFrame: Day 10
measure: Recovery rate and virus negative conversion rate (RT-PCR) of 10-day clinical symptoms (fever, cough, sputum expectoration, chest tightness, shortness of breath, dyspnea)
timeFrame: Day 10
measure: Time for the virus negative conversion (RT-PCR)
timeFrame: Up to day 28
measure: Time for observation in hospital
timeFrame: Up to day 28
measure: Length of hospital stay
timeFrame: Up to day 28
measure: Number of days in the intensive care unit
timeFrame: Up to day 28
measure: Changes in inflammatory markers at day 7: C-reactive protein
timeFrame: Day 7
measure: Changes in inflammatory markers at day 10: C-reactive protein
timeFrame: Day 10
measure: Changes in inflammatory markers at day 7: TNF-alfa
timeFrame: Day 7
measure: Changes in inflammatory markers at day 10: TNF-alfa
timeFrame: Day 10
measure: Changes in inflammatory markers at day 7: IL-6
timeFrame: Day 7
measure: Changes in inflammatory markers at day 10: IL-6
timeFrame: Day 10
measure: Changes in inflammatory markers at day 7: IL-1β
timeFrame: Day 7
measure: Changes in inflammatory markers at day 10: IL-1β
timeFrame: Day 10
measure: Changes in severity markers at day 7: D-dimer
timeFrame: Day 7
measure: Changes in severity markers at day 10: D-dimer
timeFrame: Day 10
measure: Changes in myocardial damage at day 7: hs-cTn
timeFrame: Day 7
measure: Changes in myocardial damage at day 10: hs-cTn
timeFrame: Day 10
measure: Changes in myocardial damage at day 7: NT-proBNP
timeFrame: Day 7
measure: Changes in myocardial damage at day 10: NT-proBNP
timeFrame: Day 10
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
state: Shanghai
Study officials:
affiliation: Shanghai Public Health Clinical Center
name: Hongzhou Lu, PI
role: PRINCIPAL_INVESTIGATOR
References: