Status:
COMPLETED
Survival TRial Using CytoKines in COVID-19 (STRUCK Trial)
Lead Sponsor:
University of Sao Paulo
Collaborating Sponsors:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Science Valley Research Institute
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 overwhelm...
Eligibility Criteria
Inclusion
- 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
- Oliguria;
- 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 São Paulo State Health Secretariat, resolution SS-28 of 03-Mar-2020, prepared by the Hospital das Clínicas of Medical School-USP.
Exclusion
- 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;
Key Trial Info
Start Date :
January 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04724629
Start Date
January 5 2021
End Date
July 30 2021
Last Update
July 28 2022
Active Locations (2)
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1
Faculdade de Medicina de Ribeirão Preto - USP
Ribeirão Preto, São Paulo, Brazil
2
Hospital e Maternidade Christovão da Gama
Santo André, São Paulo, Brazil, 09030-010