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PREEMPTIVE THERAPY WITH COLCHICINE IN PATIENTS OLDER THAN 70 YEARS WITH HIGH RISK OF SEVERE PNEUMONIAE DUE TO CORONAVIRUS (COLCHI-COVID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04416334
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : June 11, 2020
Sponsor:
Collaborators:
Gerencia de atención primaria área 1
Gerencia de atención primaria área 2
Gerencia Atencion Primaria Area 3
Gerencia de atención primaria área 4
Information provided by (Responsible Party):
Instituto de Investigación Marqués de Valdecilla

Brief Summary:
This is a phase 3 clinical trial, randomized, single-center, opened, controlled, to evaluate efficacy and safety of early administration of colchicines in patients older than 70 years, with high risk of pulmonary complications due to coronavirus SARS-CoV2 (COVID-19). An approximately number of 1000 subjects meeting all inclusion and none exclusion criteria will be randomized either to receive colchicines or symptomatic treatment with paracetamol during 21 days.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Infection (COVID-19) Drug: Colchicine plus symptomatic treatment (paracetamol) Drug: Symptomatic treatment (paracetamol or best symptomatic treatment based on doctor recommendations) Phase 3

Detailed Description:

The primary objective of the study is to determine whether short term course of colchicines reduces number of deaths due to COVID-19 and severe complications due to the virus in elderly patients with comorbidities.

The secondary objective is to determine the safety of colchicines in this patient population.

Approximately 1000 subjects who meet all inclusion criteria and none exclusion criteria will be randomized either to receive colchicines or symptomatic treatment (1:1 allocation ratio) during 21 days. Follow-up assessments will occur every 48 hours and always at day 7, 15 and 21 following randomization for evaluation of the occurrence of any trial endpoints or other adverse events.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1028 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: PREEMPTIVE THERAPY WITH COLCHICINE IN PATIENTS OLDER THAN 70 YEARS WITH HIGH RISK OF SEVERE PNEUMONIAE DUE TO CORONAVIRUS SARS-CoV2 (COVID-19)
Actual Study Start Date : May 25, 2020
Estimated Primary Completion Date : September 25, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Colchicine

Arm Intervention/treatment
Experimental: Colchicine plus symptomatic treatment (paracetamol).

Patients in this arm will receive study medication colchicines 0.5 mg orally (PO) twice daily for the first 3 days and then once daily for the last 18 days. If a dose is missed, it should not be replaced.

All patients should also receive best symptomatic treatment (mainly paracetamol), based on clinical practice.

Drug: Colchicine plus symptomatic treatment (paracetamol)
Colchicine plus symptomatic treatment (paracetamol).

Active Comparator: Symptomatic treatment
Symptomatic treatment (paracetamol or best symptomatic treatment based on doctor recommendations).
Drug: Symptomatic treatment (paracetamol or best symptomatic treatment based on doctor recommendations)
Symptomatic treatment (paracetamol or best symptomatic treatment based on doctor recommendations).




Primary Outcome Measures :
  1. Number of participants who die due to COVID-19 infection [ Time Frame: 21 days post-randomization ]
  2. Number of participants who require hospitalization due to COVID-19 infection [ Time Frame: 21 days post-randomization ]

Other Outcome Measures:
  1. A confirmed diagnosis from COVID-19 infection (by positive PCR test) will be mandatory . [ Time Frame: 48 hours ]
    not delayed more than 48 hours from initial symptoms



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females, at least 70 years of age.
  • Patient must have received diagnosis of COVID-19 infection within the last 24 hours, confirmed by PCR test.
  • Patient must be able to read and/or understand the informed consent information, read by another person, and the information collected on patient information document.
  • Outpatient setting (not currently hospitalized or under immediate consideration for hospitalization) or institutionalized in a nurse home.
  • Patient must meet at least one of the following high-risk criteria: diabetes mellitus, uncontrolled hypertension (systolic blood pressure ≥180 or diastolic blood pressure ≥110 mmHg), known respiratory disease (including asthma or chronic obstructive pulmonary disease), known heart failure, known coronary disease, bicytopenia or pancytopenia, or the combination of high neutrophil count and low lymphocyte count.
  • Patient must be able and willing to comply with the requirements of this study protocol.

Exclusion Criteria:

  • Patient unable to read and/or understand the informed consent information, read by another person, and the information collected on patient information document.
  • Patient currently hospitalized or under immediate consideration for hospitalization.
  • Patient under colchicine prescription for other pathologies.
  • Patient with a history of an allergic reaction or significant sensitivity to colchicine.
  • Patient with a history of gastrointestinal severe disease such as inflammatory bowel disease, gastric ulcer, chronic diarrhea, or malabsorption.
  • Patient with neuromuscular progressive previous diagnosed disease.
  • Patient with renal disease diagnosis and estimated glomerular filtration less than 30 ml/min in 1.73².
  • Patient with a history of cirrhosis, chronic active hepatitis, or severe liver disease.
  • Patient undergoing chemotherapy for cancer, including hematologic malignancies.
  • Patients who are being treated with CYP3A4 and / or glycoprotein P inhibitor drugs.
  • Immunossuppresive therapy.
  • History of cirrhosis, active chronic hepatitis, severe chronic disease defined by GOT or GPT values that exceed 3 times the upper limit of normality.
  • If the investigator considers that the patient, for any reason, would be an inappropriate candidate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04416334


Contacts
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Contact: Carlos Richard 942203333 carlos.richard@scsalud.es
Contact: Mar García, PhD 942203333 mmar.garcia@scsalud.es

Locations
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Spain
Atención primaria (Área 2) Recruiting
Laredo, Cantabria, Spain
Contact: Juan Carlos Lopez Caro         
Gerencia de atención primaria (Área 3) Recruiting
Reinosa, Cantabria, Spain
Contact: Jonatan Diaz         
Atencion primaria (AREA 1) Recruiting
Santander, Cantabria, Spain
Contact: elena Bustamante         
Gerencia de atención primaria (área 4) Recruiting
Torrelavega, Cantabria, Spain
Contact: Jose Ramon fonfria         
Sponsors and Collaborators
Instituto de Investigación Marqués de Valdecilla
Gerencia de atención primaria área 1
Gerencia de atención primaria área 2
Gerencia Atencion Primaria Area 3
Gerencia de atención primaria área 4
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Responsible Party: Instituto de Investigación Marqués de Valdecilla
ClinicalTrials.gov Identifier: NCT04416334    
Other Study ID Numbers: COLCHICOVID
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Instituto de Investigación Marqués de Valdecilla:
colchicine
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Acetaminophen
Colchicine
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents