Corona Virus Infection Clinical Trial
Official title:
Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA)
This is a phase 3, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of colchicine in adult patients diagnosed with COVID-19 infection and have at least one high-risk criterion. Approximately 6000 subjects meeting all inclusion and no exclusion criteria will be randomized to receive either colchicine or placebo tablets for 30 days.
The primary objective of this study is to determine whether short-term treatment with colchicine reduces the rate of death and lung complications related to COVID-19. The secondary objective is to determine the safety of treatment with colchicine in this patient population. Approximately 6000 patients will be enrolled to receive either colchicine or placebo (1:1 allocation ratio) for 30 days. Follow-up assessments will occur at 15 and 30 days following randomization for evaluation of the occurrence of any trial endpoints or other adverse events. Safety and efficacy will be based on data from randomized patients. An independent data and safety monitoring board (DSMB) will periodically review study results as well as the overall conduct of the study, and will make recommendations to the study Executive Steering Committee (ESC) to continue, stop or modify the study protocol. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04384445 -
Zofin (Organicell Flow) for Patients With COVID-19
|
Phase 1/Phase 2 | |
| Completed |
NCT04578210 -
Safety Infusion of NatuRal KillEr celLs or MEmory T Cells as Adoptive Therapy in COVID-19 pnEumonia or Lymphopenia
|
Phase 1/Phase 2 | |
| Completed |
NCT05065827 -
Lung Ultrasound Findings in Patients With COVID-19 in a UK ED
|
||
| Completed |
NCT04720794 -
A Study To Evaluate The Performance of the Lucira Health All-In-One COVID-19 Test Kit vs Hologic Panther Fusion
|
N/A | |
| Enrolling by invitation |
NCT04659486 -
Adolescents With COVID-19/MIS-C at HCFMUSP
|
N/A | |
| Completed |
NCT04598620 -
Non-invasive Prognostication of COVID-19 Patients by Use of Biomarkers in Exhaled Breath Condensate
|
||
| Completed |
NCT05517941 -
Effect of Active Cycle Breathing Technique Along With Incentive Spirometer on COVID19 Patient
|
N/A | |
| Recruiting |
NCT04565782 -
Corona Virus Infection Among Liver Transplant Recipients
|
||
| Recruiting |
NCT04480333 -
Safety, Tolerability and Pharmacokinetics of Inhaled Nanoparticle Formulation of Remdesivir (GS-5734) and NA-831
|
Phase 1 | |
| Active, not recruiting |
NCT04558476 -
Efficacy of CONvalescent Plasma in Patients With COVID-19 Treated With Mechanical Ventilation
|
Phase 2 | |
| Completed |
NCT05639998 -
BBV152/BBV154 Heterologus Prime-Boost Study
|
Phase 2 | |
| Completed |
NCT04526769 -
Detecting SARS-CoV-2 in Tears
|
||
| Completed |
NCT05736926 -
Anal Fissure Among Survivors of COVID-19 Virus Infection.
|
||
| Withdrawn |
NCT04386447 -
Phase II RCT to Assess Efficacy of Intravenous Administration of Oxytocin in Patients Affected by COVID-19
|
Phase 2 | |
| Completed |
NCT04523246 -
Training the Innate Immune System Against SARS-CoV-2 (COVID-19) Using the Shingrix Vaccine in Nursing Home Residents
|
Early Phase 1 | |
| Recruiting |
NCT04583566 -
Differential Expression of Cytokines, Transcriptome and miRNA in Coronavirus Disease 2019 (COVID-19) Egyptian's Patients
|
||
| Completed |
NCT04643678 -
Anakinra in the Management of COVID-19 Infection
|
Phase 2/Phase 3 | |
| Recruiting |
NCT04579588 -
Understanding Immunity to the Flu Vaccine in COVID-19 Patients
|
||
| Terminated |
NCT03331445 -
Inhaled Gaseous Nitric Oxide (gNO) Antimicrobial Treatment of Difficult Bacterial and Viral Lung (COVID-19) Infections
|
Phase 2 | |
| Recruiting |
NCT04573348 -
T Cells Response to SARS COV 2 Peptides
|