NCT04392141
|
Colchicine Plus Phenolic Monoterpenes to Treat COVID-19 |
Completed |
Phase 1|Phase 2 |
Apr/01/2020 |
Nov/01/2020 |
- Alternative id - 1399.062
- Interventions - Drug: Standard Treatment|Drug: Oral administration of Colchicine plus Herbal Phenolic Monoterpene Fractions
- Study type - Interventional
- Study results - Has Results
- Locations - Medical Biology Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran, Kermanshah, Iran, Islamic Republic of
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
- Enrollment - 120
- Age - 10 Years and older (Child, Adult, Older Adult)
- Outcome measures - Mortality Rate|SpO2|Length of Hospitalization|Lymphocyte Count|Serum Lactate Dehydrogenase
|
NCT04527562
|
Colchicine in Moderate Symptomatic COVID-19 Patients |
Completed |
Not Applicable |
Jul/14/2020 |
Dec/10/2020 |
- Alternative id - U1111-1255-3541
- Interventions - Drug: Colchicine|Drug: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Dhaka Medical College Hospital, Dhaka-1000, Bangladesh
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
- Enrollment - 299
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Time to develop clinical deterioration, defined as the time from randomization to a deterioration of two points (from the status at randomization) on a Seven-category ordinal scale.|Length of hospital stay|Number of participant requiring increased amount of supplemental oxygen|Number of participants requiring mechanical ventilation|Number of participants who die
|
NCT04756128
|
Impact of Colchicine and Low-dose Naltrexone on COVID-19 |
Enrolling by invitation |
Phase 2 |
Jan/25/2021 |
Dec/31/2021 |
- Alternative id - X2103400
- Interventions - Drug: Colchicine 0.6 mg|Drug: Naltrexone
- Study type - Interventional
- Study results - No Results Available
- Locations - Park Nicollet Methodist Hospital, Saint Louis Park, Minnesota, United States|Regions Hospital, Saint Paul, Minnesota, United States
- Study designs - Allocation: Randomized|Intervention Model: Factorial Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 164
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Progression of COVID-19 from "moderate" classification to "severe/critical"|Total duration of hospitalization|Total duration of hospitalization (from first dose of study drug to discharge)|Composite in-hospital mortality|Total duration of ICU Admission|Total duration of intubation|Total duration of time spent on HFNC or NIPPV from first dose of study drug to discharge|Total duration of time above baseline oxygen requirements from first dose of study drug to discharge|In hospital days with a fever >/= 38 degrees Celsius (00:00 to 23:59:59) from first dose of study drug to discharge (or anticipated first dose if in standard of care arm)|Incidence of adverse events associated with the study drug|Incidence of significant adverse outcomes associated with/attributable to COVID-19|Cumulative dose of corticosteroids received in ED/Hospital|Cumulative dose of remdesivir received in ED/Hospital|Discharge Anticoagulation Needs|Continuous lab results - B-Type Natriuretic Peptide|Continuous lab results - C-Reactive Protein|Continuous lab results - D-Dimer|Continuous lab results - Ferritin|Continuous lab results - Procalcitonin|Continuous lab results - Serum Creatinine|Continuous lab results - Troponin|Continuous lab results - Hepatic Function Panel (ALT/AST/Alkaline Phosphotase)|Continuous lab results - Hepatic Function Panel (Bilirubin)|Continuous lab results - Hepatic Function Panel (Protein/Albumin)|Continuous lab results - Complete Blood Count with Differential Part 1|Continuous lab results - Complete Blood Count with Differential Part 2|Continuous lab results - Complete Blood Count with Differential Part 3
|
NCT04326790
|
The GReek Study in the Effects of Colchicine in Covid-19 cOmplications Prevention |
Terminated |
Phase 2 |
Apr/03/2020 |
Apr/27/2020 |
- Alternative id - 906295542
- Interventions - Drug: Colchicine|Drug: Standard treatment
- Study type - Interventional
- Study results - No Results Available
- Locations - National and Kapodistrian University of Athens, Athens, Greece
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 105
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Clinical deterioration in the semiquantitative ordinal scale suggested by the WHO R&D committee|Maximal concentration of cardiac troponin
|
NCT04654416
|
Clinical Outcome of Patients With COVID-19 Pneumonia Treated With Corticosteroids and Colchicine |
Completed |
|
Mar/20/2020 |
Aug/20/2020 |
- Alternative id - 04-2020
- Interventions - Drug: Corticosteroid with or without colchicine
- Study type - Observational
- Study results - No Results Available
- Locations - Clínica Medellín - Grupo Quirónsalud, Medellín, Antioquia, Colombia
- Study designs - Observational Model: Case-Crossover|Time Perspective: Cross-Sectional
- Enrollment - 301
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Outcome
|
NCT04472611
|
Colchicine/Statins for the Prevention of COVID-19 Complications (COLSTAT) Trial |
Recruiting |
Phase 3 |
Oct/30/2020 |
Aug/01/2022 |
- Alternative id - 2000027950
- Interventions - Drug: Standard of Care (SOC) and Colchicine+Rosuvastatin
- Study type - Interventional
- Study results - No Results Available
- Locations - Bridgeport Hospital, Bridgeport, Connecticut, United States|Greenwich Hospital, Greenwich, Connecticut, United States|Yale New Haven Hosptial System, New Haven, Connecticut, United States|Lawrence & Memorial Hospital, New London, Connecticut, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 466
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - COVID 19 Severity
|
NCT04510038
|
Colchicine vs Current Standard of Care in Hospitalized Patients With COVID-19 and Cardiac Injury |
Suspended |
Phase 2|Phase 3 |
Jan/01/2020 |
Jan/01/2022 |
- Alternative id - 152247
- Interventions - Drug: Colchicine|Other: Covid-19 Standard of Care
- Study type - Interventional
- Study results - No Results Available
- Locations - Baptist Health South Florida, Miami, Florida, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 75
- Age - 18 Years to 100 Years (Adult, Older Adult)
- Outcome measures - All Cause Mortality|Mechanical Ventilation|Mechanical Circulatory Support|Time to Deterioration|Adverse Events|Troponin|Delta|BNP|Changes in C Reactive Protein|LOS|Re-Hospitalization|Changes in D Dimer
|
NCT04360980
|
The Effects of Standard Protocol With or Without Colchicine in Covid-19 Infection |
Completed |
Phase 2 |
Mar/20/2020 |
Jan/30/2021 |
- Alternative id - SBMU.IR.REC.165423
- Interventions - Drug: Colchicine Tablets
- Study type - Interventional
- Study results - No Results Available
- Locations - SBMU, Tehran, Iran, Islamic Republic of|Nooshin Dalili, Tehran, Iran, Islamic Republic of
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
- Enrollment - 80
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - CRPxN/R ratio change|Clinical deterioration by the WHO definition|PCR Viral Load|CT severity involvement index|LDH change
|
NCT04324463
|
Anti-Coronavirus Therapies to Prevent Progression of Coronavirus Disease 2019 (COVID-19) Trial |
Active, not recruiting |
Phase 3 |
Apr/21/2020 |
Oct/01/2022 |
- Alternative id - PHRI.ACT.COVID19
- Interventions - Drug: Colchicine|Drug: Interferon-Beta|Drug: Aspirin|Drug: Rivaroxaban
- Study type - Interventional
- Study results - No Results Available
- Locations - Hospital Adventista de Manaus, Manaus, Amazonas, Brazil|Prodal Saude S/A, Salvador, BA, Brazil|Hospital das Clinicas de Vitoria (Hospital Universitario Cassiano Antonio Moraes), Vitoria, ES, Brazil|Ubermed Serviços em Saúde Eireli - Hospital São Domingos, Uberaba, MG, Brazil|Hospital de Clínicas da Universidade Federal de Uberlândia, Uberlândia, MG, Brazil|Hospital Universitario Julio Muller, Cuiabá, Mount, Brazil|Instituto Tacchini de Pesquisa em Saude / Hospital Tacchini, Bento Goncalves, Rio Grande Do Sul, Brazil|Santa Casa de Votuporanga, Votuporanga, Sao Paulo, Brazil|Hospital Universitario Prof. Dr. Horacio Carlos Panepucci da Universidade Federal de Sao Carlos (HU-UFSCar), São Carlos, SP, Brazil|Hospital Alemão Oswaldo Cruz, São Paulo, SP, Brazil|CardiAI Inc., Calgary, Alberta, Canada|Hamilton Health Sciences, Hamilton, Ontario, Canada|London Health Sciences Centre, London, Ontario, Canada|Southlake Regional Health Centre, Newmarket, Ontario, Canada|Halton Healthcare/Oakville Trafalgar Memorial Hospital, Oakville, Ontario, Canada|Niagara Health System-St. Catharine's, St. Catharines, Ontario, Canada|Toronto Western Hospital Family Health Team, Toronto, Ontario, Canada|Windsor Regional Hospital, Windsor, Ontario, Canada|Woodstock Hospital, Woodstock, Ontario, Canada|CIUSSS de L'est-de-l'ile de Montreal, Hopital Maisonneuve-Rosemont, Montreal, Quebec, Canada|Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Quebec, Canada|Biomelab SAS, Barranquilla, Atlantico, Colombia|Clinica de la Costa LTDA, Barranquilla, Atlantico, Colombia|Instituto de Neumologico del Oriente, Bucaramanga, Santander, Colombia|Unicormed, Guayaquil, Guayas, Ecuador|Hospital de Especialidades Eugenio Espejo, Quito, Pichincha, Ecuador|Hospital Enrique Garces, Quito, Pichincha, Ecuador|Hospital General Pablo Arturo Suarez, Quito, Pichincha, Ecuador|Oncoambato, Ambato, Tungurahua, Ecuador|Giza Chest Hospital, Giza, Cairo, Egypt|Abbasia Chest Hospital, Cairo, Egypt|Abbasia Fever Hospital, Cairo, Egypt|National Hepatology and Tropical Medicine Research Institute, Cairo, Egypt|Fayoum University Hospital, Fayoum, Egypt|St. John's Medical College and Hospital, Bangalore, Karnataka, India|Bharathi Hospital and Research Center, Pune, Maharashtra, India|Sanjeevan Hospital, Pune, Maharashtra, India|Sidhu Hospital Pvt.Ltd, Doraha, Punjab, India|SRM Medical College Hospital & Research Center, Chengalpattu, Tamil Nadu, India|AIG Hospital, Hyderabad, Telangana, India|KIMS, Secunderabad, Telangana, India|Chitwan Medical College, Bharatpur-10, Bagmati, Nepal|Sahid Gangalal National Heart Center, Kathmandu, Bagmati, Nepal|Province Hospital, Karnali Province, Surkhet, Karnali, Nepal|Mechi Zonal Hospital, Bhadrapur, Province No. 1, Nepal|Koshi Zonal Hospital, Biratnagar, Province No. 1, Nepal|B.P. Koirala Institute of Health Sciences, Kathmandu, Province No.1, Nepal|Aga Khan University Hospital, Karachi, Sindh, Pakistan|Jinnah Postgraduate Medical Center, Karachi, Sindh, Pakistan|Tabba Heart Institute, Karachi, Sindh, Pakistan|Philippine General Hospital, Manila, Metro Manila, Philippines|State Budgetary Health Care Institution of Sverdlovsk region "Central city clinical hospital # 6 Ekaterinburg", Ekaterinburg, Sverdlovsk Region, Russian Federation|Central City Clinical Hospital No. 24, Yekaterinburg, Sverdlovsk Region, Russian Federation|Tver State Medical University, Tver, Tver Oblast, Russian Federation|Voronezh State Medical University named after N.N. Burdenko, Voronezh, Voronezh Region, Russian Federation|Altai Regional Center for Medical Prevention, Barnaul, Russian Federation|City Clinical Hospital No. 15 named after O.M. Filatova, Moscow, Russian Federation|National Medical Research Center for Therapy and Preventive Medicine, Moscow, Russian Federation|City Clinical Hospital No. 3, Nizhny Novgorod, Russian Federation|Rostov State Medical University, Rostov-on-Don, Russian Federation|Tiervlei Trial Centre, Cape Town, Western Cape, South Africa|University of Cape Town- Groote Schuur Hospital, Cape Town, Western Cape, South Africa|TASK Eden, George, Western Cape, South Africa|Hatta Hospital, Hatta, Dubai, United Arab Emirates|Rashid Hospital, Dubai Health Authority, Dubai, United Arab Emirates|Thumbay Hospital Dubai, Dubai, United Arab Emirates
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 6667
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Outpatient trial - Colchicine vs. control: Time from randomization to first occurrence of the composite of hospitalization or death|Outpatient trial - Aspirin vs. control: Time from randomization to first occurrence of the composite of hospitalization, death or major thrombosis (MI, stroke, ALI, or PE)|Inpatient trial - Colchicine vs. control: Time from randomization to first occurrence of the composite of high flow oxygen, mechanical ventilation, or death|Inpatient trial - Aspirin and Rivaroxaban vs. control: Time from randomization to first occurrence of the composite of high flow oxygen, mechanical ventilation, death or major thrombosis (MI, stroke, ALI, or PE)|Outpatient trial - Aspirin vs. control: Time from randomization to first occurrence of any thrombosis (MI, stroke, ALI, PE, or DVT)|Inpatient trial - Colchicine vs. control: Time from randomization to first occurrence of the composite of high flow oxygen, mechanical ventilation, or respiratory death|Inpatient trial - Aspirin vs. control: Time from randomization to first occurrence of the composite of high flow oxygen, mechanical ventilation, or respiratory death|Inpatient trial - Aspirin vs. control: Time from randomization to first occurrence of any thrombosis (MI, stroke, ALI, PE, or DVT)
|
NCT05151614
|
Adjuvant Use Of Colchicine With The Standard Therapy In Moderate And Severe Corona Virus Disease-19 Infection |
Completed |
Phase 1 |
Apr/01/2021 |
Oct/30/2021 |
- Alternative id - PRO21230003
- Interventions - Drug: Colchicine 0.5 MG
- Study type - Interventional
- Study results - No Results Available
- Locations - University of Baghdad, Baghdad, Iraq
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 160
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - - To assess the percentage of cure of the patients|- Study the time to recovery|- to assess side effects seen during the trial
|
NCT04367168
|
Colchicine Twice Daily During 10 Days as an Option for the Treatment of Symptoms Induced by Inflammation in Patients With Mild and Severe Coronavirus Disease |
Recruiting |
Phase 2 |
May/27/2020 |
Apr/27/2021 |
- Alternative id - 337420-21-1
- Interventions - Drug: Colchicine|Drug: Placebo oral tablet
- Study type - Interventional
- Study results - No Results Available
- Locations - Instituto Nacional de Ciencias Medicas y Nutricion, Mexico City, Mexico
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 174
- Age - 18 Years to 70 Years (Adult, Older Adult)
- Outcome measures - Number of patients with improvement in body temperature, myalgia, arthralgia, total lymphocyte count, D-dimer, fibrinogen and ferritin levels|Progression to severe disease
|
NCT04724629
|
Survival TRial Using CytoKines in COVID-19 (STRUCK Trial) |
Recruiting |
Phase 3 |
Jan/05/2021 |
Jul/30/2021 |
- Alternative id - 402422/2020-1
- Interventions - Biological: Ixekizumab|Biological: Aldesleukin|Drug: Colchicine|Drug: Standard of care (SOC)
- Study type - Interventional
- Study results - No Results Available
- Locations - Faculdade de Medicina de Ribeirão Preto - USP, Ribeirão Preto, SP, Brazil|Hospital e Maternidade Christovão da Gama, Santo André, SP, Brazil
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 60
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Ordinal scale of seven World Health Organization (WHO) categories of IL-17 inhibitor versus low dose IL-2 versus indirect IL-6 inhibitor (colchicine) versus standard treatment in the treatment of severe COVID-19|Time until independence from oxygen therapy in days|Ventilator free days (in days)|Assessment of worsening pulmonary involvement, defined as the presence of one of these criteria (absence or presence)|In patients who needed mechanical ventilation, time to indicate mechanical ventilation|Duration of hospitalization, in survivors|Analysis of in-hospital mortality|Analysis of general mortality
|
NCT04667780
|
Study to Investigate the Treatment Effect of Colchicine in Patients With COVID-19 |
Completed |
Phase 3 |
Dec/01/2020 |
Jul/09/2021 |
- Alternative id - ATH/IRB/Colchicine/25.11.2020
- Interventions - Drug: Colchicine|Drug: Standard COVID-19 care
- Study type - Interventional
- Study results - No Results Available
- Locations - Ayub Teaching Hospital, Abbottabad, Khyber Pakhtunkhwa, Pakistan
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 102
- Age - 18 Years to 65 Years (Adult, Older Adult)
- Outcome measures - Changes in the patients' clinical status through the 7 points ordinal scale WHO R&D Blueprint expert group|Changes in IL-6 concentrations|Improvement in the clinical status|Changes in the score for the Sequential Organ Failure Assessment (SOFA score)|Changes in the punctuation in the National Early Warning Score|Number of days with invasive mechanical ventilation|Number of days with high flow oxygen therapy|Changes in other inflammatory markers|Changes in severity markers|Changes in myocardial damage|Time until reaching a virus negative status|Length of hospital stay|Number of days in the intensive care unit.|Mortality
|
NCT04381936
|
Randomised Evaluation of COVID-19 Therapy |
Recruiting |
Phase 2|Phase 3 |
Mar/19/2020 |
Nov/01/2032 |
- Alternative id - NDPHRECOVERY|2020-001113-21|ISRCTN50189673
- Interventions - Drug: Lopinavir-Ritonavir|Drug: Corticosteroid|Drug: Hydroxychloroquine|Drug: Azithromycin|Biological: Convalescent plasma|Drug: Tocilizumab|Biological: Immunoglobulin|Drug: Synthetic neutralising antibodies|Drug: Aspirin|Drug: Colchicine|Drug: Baricitinib|Drug: Anakinra|Drug: Dimethyl fumarate|Drug: High Dose Corticosteroid|Drug: Empagliflozin|Drug: Sotrovimab
- Study type - Interventional
- Study results - No Results Available
- Locations - Kumasi Center for Collaborative Research in Tropical Medicine KNUST, Kumasi, Ghana|Indian Council of Medical Research, Division of Epidemiology and Communicable Diseases, New Delhi, India|Eijkman Oxford Clinical Research Unit (EOCRU), Eijkman Institute for Molecular Biology, Jakarta, Indonesia|Clinical Trial Unit, Oxford University Clinical Research Unit-Nepal, Patan Academy of Health Sciences, Kathmandu, Nepal|Wits Health Consortium, Johannesburg, South Africa|RECOVERY Sri Lanka & Pakistan, National Intensive Care Surveillance - M.O.R.U, Colombo, Sri Lanka|Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom|Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam
- Study designs - Allocation: Randomized|Intervention Model: Factorial Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 50000
- Age - Child, Adult, Older Adult
- Outcome measures - All-cause mortality|Duration of hospital stay|Composite endpoint of death or need for mechanical ventilation or ECMO
|
NCT04416334
|
PREEMPTIVE THERAPY WITH COLCHICINE IN PATIENTS OLDER THAN 60 YEARS WITH HIGH RISK OF SEVERE PNEUMONIAE DUE TO CORONAVIRUS |
Recruiting |
Phase 3 |
Aug/19/2020 |
Dec/31/2021 |
- Alternative id - COLCHICOVID
- Interventions - Drug: Colchicine plus symptomatic treatment (paracetamol)|Drug: Symptomatic treatment (paracetamol or best symptomatic treatment based on doctor recommendations)
- Study type - Interventional
- Study results - No Results Available
- Locations - Atención primaria (Área 2), Laredo, Cantabria, Spain|Gerencia de atención primaria (Área 3), Reinosa, Cantabria, Spain|Atencion primaria (AREA 1), Santander, Cantabria, Spain|Gerencia de atención primaria (área 4), Torrelavega, Cantabria, Spain
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
- Enrollment - 954
- Age - 60 Years and older (Adult, Older Adult)
- Outcome measures - Number of participants who die due to COVID-19 infection|Number of participants who require hospitalization due to COVID-19 infection
|
NCT04350320
|
Trial to Study the Benefit of Colchicine in Patients With COVID-19 |
Completed |
Phase 3 |
Apr/30/2020 |
Dec/30/2020 |
- Alternative id - IMIB-COLVID-2020-03
- Interventions - Drug: Colchicine Tablets|Drug: Standard therapy for COVID-19 according to the stablished hospital protocols.
- Study type - Interventional
- Study results - No Results Available
- Locations - Virgen de la Arrixaca University Clinical Hospital, Murcia, Spain
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 102
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Changes in the patients' clinical status through the 7 points ordinal scale WHO R&D Blueprint expert group|Changes in IL-6 concentrations|Improvement in the clinical status|Changes in the score for the Sequential Organ Failure Assessment (SOFA score)|Changes in the punctuation in the National Early Warning Score|Number of days with invasive mechanical ventilation|Number of days with high flow oxygen therapy|Changes in other inflammatory markers|Changes in severity markers|Changes in myocardial damage|Time until reaching a virus negative status|Length of hospital stay|Number of days in the intensive care unit.|Mortality
|
NCT04997551
|
Double Blind Randomized Clinical Trial of Use of Colchicine Added to Standard Treatment in Hospitalized With Covid-19 |
Active, not recruiting |
Phase 3 |
Sep/08/2020 |
Jan/01/2022 |
- Alternative id - EC CORONACOLCHI
- Interventions - Drug: Colchcine
- Study type - Interventional
- Study results - No Results Available
- Locations - Biodonostia Health Research Institute, San Sebastián, Guipuzcoa, Spain
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
- Enrollment - 752
- Age - 18 Years to 99 Years (Adult, Older Adult)
- Outcome measures - Proportion of patients who present death, need for mechanical ventilation or respiratory distress (Pa02 / FiO2 <300 or baseline O2 saturation ≤93%) on days +7, +14 and +30.|Each of the items (proportion of patients who suffer death, need for mechanical ventilation and development of respiratory distress) separately on days +7, +14 and +30.|Proportion of patients in each of the items of the clinical scale detailed below on days +3, +7, +14 and +30:|Time (days) until death|Proportion of patients in whom fever ≥37.8 ºC persists on days +3, +7, +14 and +30.|Evolution of the levels of C-Reactive Protein (CRP), LDH, D-dimer, ferritin, lymphocytes on days +3, +7, +14 and +30.|Proportion of patients who have received tocilizumab / other antiL6 or antiL1 drug / corticosteroids on days +3, +7, +14 and +30.|Proportion of patients experiencing serious unexpected adverse reactions that require discontinuation of the investigational product.
|
NCT04762771
|
Colchicine for the Treatment of Cardiac Injury in Hospitalized Patients With COVID-19 (COLHEART-19) |
Terminated |
Phase 1|Phase 2 |
Dec/01/2020 |
Oct/25/2021 |
- Alternative id - 152247
- Interventions - Drug: Colchicine
- Study type - Interventional
- Study results - Has Results
- Locations - Baptist Hospital of Miami, Miami, Florida, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 2
- Age - 18 Years to 99 Years (Adult, Older Adult)
- Outcome measures - Mortality|Mechanical Ventilation|Mechanical Circulatory Support|Time (Days) to the Primary End Point|Peak and Delta (Change From Baseline) Troponin Level|Baseline Brain Natriuretic Peptide (BNP) Level|Inflammatory Biomarkers|Hospital Length of Stay|Need for Re-hospitalization|Change in Inflammatory Biomarkers
|
NCT04322682
|
Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) |
Terminated |
Phase 3 |
Mar/23/2020 |
Jan/21/2021 |
- Alternative id - MHIPS-2020-001|3R01HL146206-02S1
- Interventions - Drug: Colchicine|Drug: Placebo oral tablet
- Study type - Interventional
- Study results - Has Results
- Locations - Mayo Clinic - Phoenix, Phoenix, Arizona, United States|Yuma Regional Medical Center Cancer Center, Yuma, Arizona, United States|Centric Health Resources Inc., Bakersfield, California, United States|Westside Medical Associates of Los Angeles, Beverly Hills, California, United States|Rancho Research Institute, Downey, California, United States|University of California San Francisco - Zuckerberg San Francisco General Hospital, San Francisco, California, United States|Mayo Clinic - Jacksonville, Jacksonville, Florida, United States|South Florida Research Organization, Medley, Florida, United States|Miami Center for Advanced Cardiology, Miami Beach, Florida, United States|Mayo Clinic - Rochester, Rochester, Minnesota, United States|North Mississippi Medical Clinics, Inc., Tupelo, Mississippi, United States|New York Langone Health, New York, New York, United States|University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States|Baylor Scott & White Research Institute - Pharmacy, Dallas, Texas, United States|University of Texas(UT) Southwestern Medical Center, Dallas, Texas, United States|Spring Clinical Research, Houston, Texas, United States|Instituto do Coração (InCor), School of Medicine, University of Sao Paulo, São Paulo, Sao Paulo, Brazil|Hospital Universitário Bragança Paulista, Bragança Paulista, Brazil|Instituto Cruzaltense de Cardiologia, Cruz Alta, Brazil|Hospital de Clínicas de Passo Fundo, Passo Fundo, Brazil|Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil|Hospital Samaritano Higienópolis, São Paulo, Brazil|Montreal Heart Institute, Montreal, Quebec, Canada|University General Hospital of Athens "Attikon", Chaïdári, Athens, Greece|General Hospital of Kozani "Mamatsio", Kozáni, Greece|Tread Research, Tygerberg Hospital, Cape Town, South Africa|Hospital Universitario La Paz, IdiPaz, La Paz, Madrid, Spain|Hospital Universitario de La Princesa, Madrid, Spain|Hospital Universitario Ramón y Cajal, Madrid, Spain|Fundación Jiménez Díaz, Madrid, Spain|Hospital Universitario 12 de Octubre, Madrid, Spain|Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
- Enrollment - 4506
- Age - 40 Years and older (Adult, Older Adult)
- Outcome measures - Number of Participants Who Died or Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization.|Number of Deaths in the 30 Days Following Randomization.|Number of Participants Who Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization.|Number of Participants Who Required Mechanical Ventilation in the 30 Days Following Randomization.
|
NCT04359095
|
Effectiveness and Safety of Medical Treatment for SARS-CoV-2 (COVID-19) in Colombia |
Completed |
Phase 2|Phase 3 |
Aug/18/2020 |
Jun/30/2021 |
- Alternative id - 76968
- Interventions - Drug: Emtricitabine/tenofovir|Drug: Colchicine Pill|Drug: Rosuvastatin|Other: Standard treatment
- Study type - Interventional
- Study results - No Results Available
- Locations - Clinica santa Maria del lago, Bogota, DC, Colombia|Clínica Reina Sofía, Bogotá, Colombia|Fundacion Cardio Infantil, Bogotá, Colombia|Hospital Universitario San Ignacio, Bogotá, Colombia|Clinica Universitaria Colombia, Bogotá, Colombia|Hospital Universitario Nacional de Colombia, Bogotá, Colombia
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 650
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Mortality|Number of Participants with Treatment Related Severe Adverse Events as Assessed by the NCORP Guidance for Collection of Adverse Events Related to COVID-19 Infection|Time to death|Number of Participants that are transferred to the Intensive Care Unit (ICU)|Number of Participants that need Mechanical Ventilation Support with endotracheal intubation.|Number of participants Cured assessed by Nasopharyngeal swab, oropharyngeal swab, and blood aspiration for COVID19 (RT-PCR) without clinical symptoms and normal chest X ray|Number of Participants with Any Adverse Event Related to Treatment Assessed by the NCORP Guidance for Collection of Adverse Events Related to COVID-19 Infection
|
NCT05118737
|
Adding Colchicine to Tocilizumab in Patients With Severe COVID-19 Pneumonia. |
Recruiting |
Early Phase 1 |
Oct/01/2021 |
Aug/30/2022 |
- Alternative id - MRC-01-21-299
- Interventions - Drug: Colchicine
- Study type - Interventional
- Study results - No Results Available
- Locations - Alaa Rahal, Doha, DA, Qatar
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 230
- Age - 18 Years to 90 Years (Adult, Older Adult)
- Outcome measures - Rate of invasive mechanical ventilation|Time to invasive mechanical ventilation|Duration of invasive mechanical ventilation|Mortality|ICU length of stay|Hospital length of stay|Change in inflammatory markers (CRP)|Change in inflammatory markers, (D-Dimer)|Change in inflammatory markers( IL-6)
|
NCT05038449
|
Study to Evaluate the Efficacy and Safety of Colchicine Tablets in Patients With COVID-19 |
Not yet recruiting |
Not Applicable |
Sep/06/2021 |
Sep/01/2023 |
- Alternative id - KPC/QSXJ/01
- Interventions - Drug: Colchicine Tablets|Drug: Standard therapy
- Study type - Interventional
- Study results - No Results Available
- Locations - Shanghai Public Health Clinical Center, Shanghai, Shanghai, China
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 60
- Age - 18 Years to 65 Years (Adult, Older Adult)
- Outcome measures - Recovery rate of clinical symptoms (fever, cough, expectoration, chest tightness, shortness of breath, dyspnea) and virus negative conversion rate (RT-PCR) at day 7|Changes in the patients' clinical status through the WHO Clinical Progression Scale (scores 0-10) at day 7|Changes in the patients' clinical status through the WHO Clinical Progression Scale (scores 0-10) at day 10|Ventilator usage rate, usage time at day 7|Ventilator usage rate, usage time at 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)|Time for the virus negative conversion (RT-PCR)|Time for observation in hospital|Length of hospital stay|Number of days in the intensive care unit|Changes in inflammatory markers at day 7: C-reactive protein|Changes in inflammatory markers at day 10: C-reactive protein|Changes in inflammatory markers at day 7: TNF-alfa|Changes in inflammatory markers at day 10: TNF-alfa|Changes in inflammatory markers at day 7: IL-6|Changes in inflammatory markers at day 10: IL-6|Changes in inflammatory markers at day 7: IL-1β|Changes in inflammatory markers at day 10: IL-1β|Changes in severity markers at day 7: D-dimer|Changes in severity markers at day 10: D-dimer|Changes in myocardial damage at day 7: hs-cTn|Changes in myocardial damage at day 10: hs-cTn|Changes in myocardial damage at day 7: NT-proBNP|Changes in myocardial damage at day 10: NT-proBNP
|
NCT04539873
|
Impact of Colchicine in Hospitalized Colombian Patients With COVID-19 |
Terminated |
Phase 3 |
Apr/30/2021 |
Oct/30/2021 |
- Alternative id - 5175
- Interventions - Drug: Colchicine 0.5 MG|Combination Product: CONTROL GROUP
- Study type - Interventional
- Study results - No Results Available
- Locations - Fundación Universitaria de Ciencias de La Salud, Bogota, Cundinamarca, Colombia
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment
- Enrollment - 128
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Number of participants who die or require transfer to Intesive care unit|Number of participants who die
|
NCT04603690
|
Study to Investigate the Benefits of Colchicine in Patients With COVID-19 |
Withdrawn |
Phase 3 |
Dec/15/2020 |
Jun/14/2021 |
- Alternative id - LUMHS/REC/893
- Interventions - Drug: Colchicine
- Study type - Interventional
- Study results - No Results Available
- Locations -
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 0
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Improvement in the clinical status|Changes in IL-6 concentrations|Changes in the score for the Sequential Organ Failure Assessment (SOFA score)|Changes in the punctuation in the National Early Warning Score|Number of days with invasive mechanical ventilation or ECMO|Number of days with high flow oxygen therapy|Changes in other inflammatory markers (C-reactive protein, IL-6) from randomization|Changes in severity markers (D-dimer, lymphocytes, and ferritin) from randomization|Changes in myocardial damage and stress markers (hsTnT and NT-proBNP) from randomization.|Time until reaching a virus negative status by RT-PCR assay|Length of hospital stay|Number of days in the intensive care unit|Mortality by causes
|
NCT04375202
|
Colchicine in COVID-19: a Pilot Study |
Recruiting |
Phase 2 |
Apr/18/2020 |
Oct/31/2022 |
- Alternative id - 2020-001475-33
- Interventions - Drug: Colchicine 1 MG Oral Tablet
- Study type - Interventional
- Study results - No Results Available
- Locations - Associazione Italiana Pneumologi Ospedalieri, Milan, Italy|Società Italiana di Reumatologia, Milan, Italy
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 308
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Rate of entering the critical stage|Trend of White blood cell count|Change of the "Sequential Organ failure Assessment" (SOFA)|Rate of biochemical criterion (CK, ALT, ferritin) recovery|Rate of disease remission
|
NCT04355143
|
Colchicine to Reduce Cardiac Injury in COVID-19 (COLHEART-19) |
Completed |
Phase 2 |
May/01/2020 |
Jul/21/2021 |
- Alternative id - 20-000685
- Interventions - Drug: Colchicine Tablets|Other: Current care per UCLA treating physicians
- Study type - Interventional
- Study results - No Results Available
- Locations - UCLA Ronald Reagan Medical Center, Los Angeles, California, United States|UCLA Santa Monica Hospital, Santa Monica, California, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 91
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Composite of all-cause mortality, need for mechanical ventilation, or need for mechanical circulatory support (MCS)|Delta (peak minus baseline) troponin level|Delta (baseline to peak) brain natriuretic peptide (BNP) level|Change in left ventricular ejection fraction (LVEF) on echocardiography|Delta (peak minus baseline) C-Reactive protein (CRP) inflammatory biomarker level|Delta (peak minus baseline) D-Dimer inflammatory biomarker level|Time (days) to primary endpoint|Number of participants requiring mechanical ventilation|Number of participants requiring mechanical circulatory support (MCS)|Re-hospitalization at 90 days|All-cause mortality
|
NCT04818489
|
Colchicine and Post-COVID-19 Pulmonary Fibrosis |
Completed |
Phase 4 |
Mar/25/2021 |
Oct/20/2021 |
- Alternative id - PR00202
- Interventions - Drug: Colchicine 0.5 MG|Other: the standard protocol only
- Study type - Interventional
- Study results - No Results Available
- Locations - El-Demerdash Hospital, Cairo, Egypt
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 260
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Clinical status|Pulmonary fibrosis at week 2|Pulmonary fibrosis at 45 days|C-reactive protein|Ferritin|Erythrocyte sedimentation rate|Lactate dehydrogenase|Adverse events|Pulmonary function test: FVC|Pulmonary function test: FEV1
|
NCT04328480
|
The ECLA PHRI COLCOVID Trial. Effects of Colchicine on Moderate/High-risk Hospitalized COVID-19 Patients. |
Completed |
Phase 3 |
Apr/17/2020 |
Apr/26/2021 |
- Alternative id - COLCOVID version 2.0
- Interventions - Drug: Colchicine|Other: Local standard of care
- Study type - Interventional
- Study results - No Results Available
- Locations - Sanatorio Parque, Rosario, Santa Fe, Argentina
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 1279
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Composite outcome: New requirement for mechanical ventilation or death|Mortality|New requirement for mechanical ventilation or death from respiratory failure|New requirement for mechanical ventilation or death from non-respiratory failure|Mortality due to respiratory failure|Mortality due to non-respiratory failure|In hospital - Composite outcome|In hospital - Mortality|Composite outcome (New requirement for mechanical ventilation or death) evaluated in Non-intubated population|Mortality evaluated in Non-intubated population|Mean WHO descriptive score of COVID-19 during hospitalization|Highest WHO descriptive score of COVID-19 during hospitalization
|
NCT05246072
|
Effect of Combined Use of Ivermectin and Colchicine in COVID-19 Patients |
Recruiting |
Phase 4 |
Nov/01/2021 |
Feb/28/2022 |
- Alternative id - FAMSU R 179 / 2021
- Interventions - Drug: Ivermectin + colchicine|Drug: Colchicine
- Study type - Interventional
- Study results - No Results Available
- Locations - Ain Shams University hospitals, Cairo, Egypt
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 60
- Age - 18 Years to 80 Years (Adult, Older Adult)
- Outcome measures - length of oxygen requirement
|
NCT04492358
|
Treatment for Moderate/Severe COVID-19 in a Fragile and Vulnerable Population, Admitted to a Geriatric Hospital Unit or in a Transicional Care Center |
Recruiting |
Phase 2|Phase 3 |
Oct/22/2020 |
Oct/01/2021 |
- Alternative id - 2020-002462-14
- Interventions - Drug: Colchicine|Drug: Prednisone tablet|Drug: standard of care
- Study type - Interventional
- Study results - No Results Available
- Locations - Centre Blauclínic Dolors Aleu, Barcelona, Spain|Hospital Clinic, Department of Internal Medicine, Barcelona, Spain|Clinica Sant Antoni, Barcelona, Spain
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 144
- Age - 65 Years and older (Older Adult)
- Outcome measures - Number of patients that a short cycle of steroids administered together with colchicine reduces mortality from COVID-19|Number and grade of adverse events at group of colchicine and glucocorticoids throughout the treatment and in the two weeks following treatment|Percentage of patients who stop medication due to adverse events.|Severity of symptoms by COVID-19 in the two treatment arms
|
NCT04363437
|
COlchicine in Moderate-severe Hospitalized Patients Before ARDS to Treat COVID-19 |
Terminated |
Phase 2 |
Apr/26/2020 |
Jul/31/2020 |
- Alternative id - 2020-04-12
- Interventions - Drug: Colchicine|Drug: Usual Care
- Study type - Interventional
- Study results - Has Results
- Locations - Maimonides Medical Center, Brooklyn, New York, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 21
- Age - 18 Years to 100 Years (Adult, Older Adult)
- Outcome measures - Percentage of Patients Requiring Supplemental Oxygen Beyond 8L Nasal Cannula|Percentage of Patients Who Will Require Mechanical Ventillation|Mortality
|
NCT04867226
|
Effectiveness of Colchicine Among Patients With COVID-19 Infection |
Completed |
Phase 2 |
May/08/2021 |
Jun/18/2021 |
- Alternative id - Effectiveness of colchicine
- Interventions - Drug: Colchicine 0.5 MG|Drug: usual care treatment
- Study type - Interventional
- Study results - No Results Available
- Locations - Hawler medical university ,Rozhawa emergency hospital, Erbil, Iraq
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 100
- Age - 18 Years to 70 Years (Adult, Older Adult)
- Outcome measures - need for supplemental oxygen|length of hospital stay|need for invasive mechanical ventilation|death rate|oxygen saturation measurement|musculoskeletal symptoms|change in severity marker|change in inflammatory marker|change in marker|adverse effect
|
NCT04322565
|
Colchicine Counteracting Inflammation in COVID-19 Pneumonia |
Recruiting |
Phase 2 |
Apr/20/2020 |
Dec/21/2020 |
- Alternative id - ColCOVID-19
- Interventions - Drug: Colchicine
- Study type - Interventional
- Study results - No Results Available
- Locations - Azienda Ospedaliero Universitaria di Parma, Parma, PR, Italy
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 310
- Age - 18 Years to 100 Years (Adult, Older Adult)
- Outcome measures - Clinical improvement|Hospital discharge|Death|Clinical status|Mechanical ventilhation|Hospitalization|Time from treatment initiation to death|Time to Negativization COVID 19|Fever
|
NCT04516941
|
CorONa Virus edoxabaN ColchicinE (CONVINCE) COVID-19 |
Recruiting |
Phase 3 |
Jan/21/2021 |
Jun/30/2023 |
- Alternative id - CONVINCE Version 1.0 12052020
- Interventions - Drug: Edoxaban Tablets|Drug: Colchicine Tablets
- Study type - Interventional
- Study results - No Results Available
- Locations - Jessa Ziekenhuis, Hasselt, Belgium|Azienda ULSS n.4 "Veneto Orientale", Jesolo, Veneto, Italy|ASST Papa Giovanni XXIII, Bergamo, Italy|ASST Rhodense, Garbagnate Milanese, Italy|Azienda Socio Sanitaria Territoriale di Lecco, Lecco, Italy|ASST Grande Ospedal Metropolitano Niguardia, Milan, Italy|IRCCS Policlinico San Matteo, Pavia, Italy|Azienda Unita' Sanitaria Locale della Romagna, Ravenna, Italy|Hospital Clinic de Barcelona, Barcelona, Spain|Ospedale regionale Lugano, Lugano, Ticino, Switzerland|Bern University Hospital, Bern, Switzerland
- Study designs - Allocation: Randomized|Intervention Model: Factorial Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 420
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Edoxaban vs. no active treatment|Colchicine vs no active treatment|Number of patients with asymptomatic proximal deep-vein thrombosis|Number of patients with symptomatic proximal or distal deep-vein thrombosis|Number of patient with symptomatic pulmonary embolism or thrombosis|Number of patients with myocardial infarction|Number of patients with ischemic stroke|Number of patients with non-CNS systemic embolism|Number of deaths|Ventilation need
|
NCT04403243
|
COLchicine Versus Ruxolitinib and Secukinumab In Open Prospective Randomized Trial |
Recruiting |
Phase 2 |
May/08/2020 |
Aug/23/2020 |
- Alternative id - MSU080520
- Interventions - Drug: Colchicine|Drug: Ruxolitinib 5 MG|Drug: Secukinumab 150 MG/ML Subcutaneous Solution [COSENTYX]|Other: standard therapy
- Study type - Interventional
- Study results - No Results Available
- Locations - Lomonosov Moscow State University Medical Research and Educational Center, Moscow, Moscow Region, Russian Federation
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 70
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - change from baseline in clinical assessment score COVID 19 (CAS COVID 19) Frame: baseline|Combine endpoint: Time to death or mechanical ventilation|C-reactive protein|D-dimer|EuroQol Group. EQ-5D™|exposure area on lung CT
|