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

  • days left to enroll
  • participants needed
  • sponsor
    University of Sao Paulo
Updated on 27 January 2021


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.

Condition COVID19
Treatment aldesleukin, colchicine, Standard of Care (SOC), Ixekizumab
Clinical Study IdentifierNCT04724629
SponsorUniversity of Sao Paulo
Last Modified on27 January 2021


Yes No Not Sure

Inclusion Criteria

Positive result in the quantitative real-time PCR (qPCR) test for SARS-CoV-2 in the respiratory tract
Pneumonia confirmed by chest imaging and
Respiratory rate 24 IRPM (for adults) or
O2 saturation <93% or
No improvement in O2 saturation, despite oxygen supply or
Arterial hypotension; or
Changes in capillary filling time; or
Changes in the level of consciousness; or
IMPORTANT: The presence of increased respiratory rate or desaturation (items
a" and "b") are criteria for hospital admission. Items "c" to "g" are
considered criteria for ICU admission
Following the recommendations of The So Paulo State Health Secretariat
resolution SS-28 of 03-Mar-2020, prepared by the Hospital das Clnicas of
Medical School-USP

Exclusion Criteria

Age <18 years
Refuse to sign the Informed Consent Form
Patient's decision that their involvement is not in their interest
Severe known liver disease (eg cirrhosis, with aminotransferase levels> 5 times the reference value limit)
Pregnancy or breastfeeding period
Severe bacterial infection
Severe diarrhea
Diverticulitis or intestinal perforation
Infection known as HIV
Presence of one of the following uncontrolled or unstable cardiovascular diseases: stroke, ECG confirmed acute ischemia or myocardial infarction and / or clinically significant dysrhythmia; Known history of gastrointestinal bleeding, uncontrolled peptic ulcer or uncontrolled duodenal ulcer
Known history of hemophilia or other bleeding disorders
History of organ transplantation, congenital immunodeficiency
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Phone Email

Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note