Survival TRial Using CytoKines in COVID-19 (STRUCK 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.

Conditions

• Covid19

Interventions

BIOLOGICAL

Ixekizumab

80 mg of IL-17 inhibitor

BIOLOGICAL

Aldesleukin

1.5 million IU (low-dose) of IL-2

DRUG

Colchicine

0.5 mg of indirect IL-6 inhibitor

DRUG

Standard of care (SOC)

Active comparator (Corticoids and antiretrovirals)

Sponsors & Collaborators

• Conselho Nacional de Desenvolvimento Científico e Tecnológico

  collaborator OTHER_GOV

• Science Valley Research Institute

  collaborator OTHER

• University of Sao Paulo

  lead OTHER

Principal Investigators

• Fernando Rodrigues, MD, PhD · Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto, USP, SP, Brazil

• Eduardo Ramacciotti, MD, PhD · Hospital e Maternidade Dr. Christóvão da Gama, Grupo Leforte, Santo André, SP, Brazil

• Leandro B Agati, PhD · Hospital Leforte Liberdade, SP, Brazil

• Esper Kallas, MD, PhD · Hospital das Clinicas de Sao Paulo (USP)

• Renato D Lopes, MD, PhD · Duke University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-05

Primary Completion

2021-03-31

Completion

2021-07-30

FDA Drug

Yes

Countries

• Brazil

Study Locations