COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04330638

Bart Lambrecht, MD, PhD

bart.lambrecht@uzgent.be

2020-04-01

Completed

RCT

Randomized

Factorial

Open label

multi-center

Treatment

inclusion criteria: recent ( ≥ 6 days of flu-like symptoms or malaise yet ≤16 days of flu-like symptoms or malaise prior to randomization) infection with covid-19. confident covid-19 diagnosis confirmed by antigen detection test and/or pcr and/or positive serology, or any emerging and validated diagnostic laboratory test for covid-19 within this period. in some patients, it may be impossible to get a confident laboratory confirmation of covid-19 diagnosis after 24h of hospital admission because viral load is low and/or problems with diagnostic sensitivity. in those cases, in absence of an alternative diagnosis, and with highly suspect bilateral ground glass opacities on recent (<24h) chest-ct scan (confirmed by a radiologist and pulmonary physician as probable covid-19), and a typical clinical and chemical diagnosis with signs of cytokine release syndrome, a patient can be enrolled as probable covid-19 infected. in all cases, this needs confirmation by later seroconversion. presence of hypoxia defined as pao2/fio2 below 350 while breathing room air in upright position or pao2/fio2 below 280 on supplemental oxygen and immediately requiring high flow oxygen device or mechanical ventilation signs of cytokine release syndrome defined as any of the following: serum ferritin concentration >1000 mcg/l and rising since last 24h single ferritin above 2000 mcg/l in patients requiring immediate high flow oxygen device or mechanical ventilation lymphopenia defined as <800 lymphocytes/microliter) and two of the following extra criteria ferritin > 700 mcg/l and rising since last 24h increased ldh (above 300 iu/l) and rising last 24h d-dimers > 1000 ng/ml and rising since last 24h crp above 70mg/l and rising since last 24h and absence of bacterial infection if three of the above are present at admission, no need to document 24h rise chest x-ray or ct scan showing bilateral infiltrates within last 2 days admitted to specialized covid-19 ward or an icu ward taking care of covid-19 patients age ≥ 18yrs male or female willing and able to provide informed consent or legal representative willing to provide informed consent

- patients with known history of serious allergic reactions, including anaphylaxis, to any of the study medications, or any component of the product. - mechanical ventilation > 24 h at randomization - patient on ecmo at time of screening - clinical frailty scale above 3 (this frailty score is the patient status before first symptoms of covid-19 episode.) - active bacterial or fungal infection - unlikely to survive beyond 48h - neutrophil count below 1500 cells/microliter - platelets below 50.000/microliter - patients enrolled in another investigational drug study - patients on high dose systemic steroids (> 20 mg methylprednisolone or equivalent) for covid-19 unrelated disorder - patients on immunosuppressant or immunomodulatory drugs - patients on current anti-il1 or anti-il6 treatment - signs of active tuberculosis - serum transaminase levels >5 times upper limit of normal - bowel perforation or diverticulitis - pregnant or breastfeeding females (all female subjects deemed of childbearing potential by the investigator must have negative pregnancy test at screening) - women of childbearing potential must have a negative serum pregnancy test pre-dose on day 1. woùmen of childbearing potential must consistently and correctly use (during the entire treatment period and 3 months after last reatment) 1 highly effective method for contraception.

6

University Hospital, Ghent

18

80

Belgium

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

342

Time to Clinical Improvement

None

Phase 3

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