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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Covid19; Colchicine
• Intervention / Treatment: Drug: Colchicine Tablets; Drug: Standard therapy

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hongzhou Lu, PI; Phone Number: 3222 +86-021-37990333; Email: luhongzhou@fudan.edu.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201508
      • Shanghai Public Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Colchicine 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).	Drug: Colchicine Tablets; Colchicine Tablets (Each tablet contains colchicine 0.5mg); Drug: Standard therapy; Standard therapy for COVID-19 according to the Novel Coronavirus Pneumonia Diagnosis and Treatment Plan (Trial 8th Edition)
Placebo Comparator: Standard therapy group; Standard therapy for COVID-19 according to the Novel Coronavirus Pneumonia Diagnosis and Treatment Plan (Trial 8th Edition).	Drug: Standard therapy; Standard therapy for COVID-19 according to the Novel Coronavirus Pneumonia Diagnosis and Treatment Plan (Trial 8th Edition)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Public Health Clinical Center
• Collaborators: Kunming Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Hongzhou Lu, PI, Shanghai Public Health Clinical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): September 6, 2021
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: September 5, 2021
• First Submitted That Met QC Criteria: September 7, 2021
• First Posted (Actual): September 9, 2021

Study Record Updates

• Last Update Posted (Actual): September 9, 2021
• Last Update Submitted That Met QC Criteria: September 7, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19; Colchicine Tablets; IIT Study
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Gout Suppressants; Colchicine
• Other Study ID Numbers: KPC/QSXJ/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No