Other Clinical Trial - Survival TRial Using CytoKines in COVID-19 (STRUCK

Status Completed

Clinical Trial Summary

Currently, there are few approved treatments for COVID-19, antiretroviral (remdesivir) and corticoids. With about 15% of COVID-19 patients suffering from severe disease health system will be overwhelmed. Treatments approaches to inhibit viral replication (antiretroviral and extended spectrum antiviral drugs), such as Remdesivir and Hydroxychloroquine are being used. In severe cases, by CT scans investigators are able to observe that these patients seem to be dying with fibrosis and lung vasculitis. It is hypothesised that targeting vasculitis and lung inflammation secondary to the viral infection may help patients' survival (reducing mortality) and/or decrease time in mechanical ventilators. It is proposed a 4-arm trial, converted to 2 after interim analysis (60 patients for the initial phase, sample size recalculation after initial analysis and 2 arms beyond). In initial phase, IL-6 indirect inhibitor (colchicine), in first arm; IL-17 inhibitor, an innovative target never tested (at this moment) in COVID-19 severe patients, in second study arm. Both approaches (indirect IL-6 and Il-17) are related to modulation of inflammatory immune response. Finally, in third arm, IL-2 low dose. This cytokine was identified as Treg upregulation. Treg levels decrease in hepatitis C virus (HCV) associated vasculitis and increase in vasculitis resolution. In fourth arm, control group, standard of care. Initially, for the first 60 included patients, the study will comprise 4 arms (15 patients per arm, randomization ratio 1:1:1:1). An interim effectiveness and safety analysis at this point will guide the selection of one single treatment strategy (adaptative study) to be carried on after that, comparatively with the control group. The multi-site trial planned enrollment duration of 4-6 months and for each participant will be approximately 4 weeks. This trial will bring complementary data to the global effort in COVID-19 cases resolution.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04724629
Study type	Interventional
Source	University of Sao Paulo
Contact
Status	Completed
Phase	Phase 3
Start date	January 5, 2021
Completion date	July 30, 2021

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05047692` - Safety and Immunogenicity Study of AdCLD-CoV19-1: A COVID-19 Preventive Vaccine in Healthy Volunteers	Phase 1
Recruiting	`NCT04395768` - International ALLIANCE Study of Therapies to Prevent Progression of COVID-19	Phase 2
Terminated	`NCT04555096` - A Trial of GC4419 in Patients With Critical Illness Due to COVID-19	Phase 2
Completed	`NCT04506268` - COVID-19 SAFE Enrollment	N/A
Completed	`NCT04508777` - COVID SAFE: COVID-19 Screening Assessment for Exposure
Completed	`NCT04961541` - Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine	Phase 1/Phase 2
Active, not recruiting	`NCT04546737` - Study of Morphological, Spectral and Metabolic Manifestations of Neurological Complications in Covid-19 Patients	N/A
Completed	`NCT04532294` - Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants	Phase 1
Terminated	`NCT04542993` - Can SARS-CoV-2 Viral Load and COVID-19 Disease Severity be Reduced by Resveratrol-assisted Zinc Therapy	Phase 2
Completed	`NCT04494646` - BARCONA: A Study of Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19)	Phase 2
Not yet recruiting	`NCT04543006` - Persistence of Neutralizing Antibodies 6 and 12 Months After a Covid-19	N/A
Terminated	`NCT04581915` - PHRU CoV01 A Trial of Triazavirin (TZV) for the Treatment of Mild-moderate COVID-19	Phase 2/Phase 3
Completed	`NCT04387292` - Ocular Sequelae of Patients Hospitalized for Respiratory Failure During the COVID-19 Epidemic	N/A
Completed	`NCT04537663` - Prevention Of Respiratory Tract Infection And Covid-19 Through BCG Vaccination In Vulnerable Older Adults	Phase 4
Completed	`NCT04507867` - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III	N/A
Not yet recruiting	`NCT04527211` - Effectiveness and Safety of Ivermectin for the Prevention of Covid-19 Infection in Colombian Health Personnel	Phase 3
Completed	`NCT04979858` - Reducing Spread of COVID-19 in a University Community Setting: Role of a Low-Cost Reusable Form-Fitting Fabric Mask	N/A
Not yet recruiting	`NCT05038449` - Study to Evaluate the Efficacy and Safety of Colchicine Tablets in Patients With COVID-19	N/A
Completed	`NCT04610502` - Efficacy and Safety of Two Hyperimmune Equine Anti Sars-CoV-2 Serum in COVID-19 Patients	Phase 2
Active, not recruiting	`NCT06042855` - ACTIV-6: COVID-19 Study of Repurposed Medications - Arm G (Metformin)	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Survival TRial Using CytoKines in COVID-19 (STRUCK Trial) — STRUCK

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms