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

NCT05038449 | Unknown

• 1 other identifier: KPC/QSXJ/01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Colchicine

Keywords

COVID-19; Colchicine Tablets; IIT Study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (23)

• Changes in the patients' clinical status through the WHO Clinical Progression Scale (scores 0-10) at day 7

  Day 7

• Changes in the patients' clinical status through the WHO Clinical Progression Scale (scores 0-10) at day 10

  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

Study Arms (2)

Colchicine group

EXPERIMENTAL

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; Drug: Standard therapy

Standard therapy group

PLACEBO COMPARATOR

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

Drug: Standard therapy

Interventions

Colchicine Tablets DRUG

Colchicine Tablets (Each tablet contains colchicine 0.5mg)

Colchicine group

Standard therapy DRUG

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

Colchicine group; Standard therapy group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At the time of signing ICF, the subjects were 18 to 65 years old (including 18 and 65 years old), both men and women;
• Within 72 hours before screening, any samples confirmed by the laboratory were positive for SARS-CoV-2;
• Clinical classification was ordinary type according to the Novel Coronavirus Pneumonia Diagnosis and Treatment Plan (Trial 8th Edition)；
• Symptoms appeared ≤ 5 days before randomization; Such as fever, cough, shortness of breath, sore throat and diarrhea;
• Subjects were able to communicate well with the investigator, and understand and comply with the requirements of this study, understand and sign the ICF.

You may not qualify if:

• 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.
• 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.
• People who are known to be allergic to the test drug and its components;
• People with inflammatory bowel disease, chronic diarrhea, malabsorption;
• People with previous neuromuscular disease;
• People with severe renal insufficiency (glomerular filtration rate \<30 mL/min/1.73m2);
• 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;
• Patients who are taking colchicine or have a history of colchicine treatment (mainly chronic prescriptions for familial Mediterranean fever or gout);

Sponsors & Collaborators

• Shanghai Public Health Clinical Center: lead
• Kunming Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, 201508, China

Location

MeSH Terms

Conditions

COVID-19

Interventions

Colchicine; Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Hongzhou Lu, PI

  Shanghai Public Health Clinical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongzhou Lu, Ph.D

CONTACT

+86-021-37990333; luhongzhou@fudan.edu.cn

Hongzhou Lu, PI

CONTACT

+86-021-37990333; luhongzhou@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director of Shanghai Public Health Clinical Center affiliated to Fudan University

Study Record Dates

• First Submitted: September 5, 2021
• First Posted: September 9, 2021
• Study Start: September 6, 2021
• Primary Completion: June 1, 2023
• Study Completion: September 1, 2023
• Last Updated: September 9, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)