COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04443881

Patricia Fanlo Mateo, PhD

patricia.fanlo.mateo@navarra.es

2020-06-23

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

- inclusion criteria: - age 18-80 years. - severe pneumonia covid-19 defined as: - nasopharyngeal smear with rcp positive for sars-cov-2 - x-rays (or other technique) pulmonary infiltrates compatible with pneumonia. - 1 or more of the following criteria: - ambient air oxygen saturation <= 94% measured with a pulse oximeter. - pa:fio2 (partial pressure o2/fraction of inspired o2) <=300. - sa:fio2 (o2 saturation measured with pulse oximeter/ fraction of inspired o2) <=350. - high suspicion of css that could resemble mas-like: represented by il-6 values > 40 pg/ml and/or ferritin >500 ug/l and/or pcr > 30 mg/l (rationale: ≥ 5 upper normal limit) and/or ldh >300 ui/l. we have chosen these parameters because they are implemented in all the participating hospitals, they are a reflection of the cytokine storm and they have also been significant in terms of predicting mortality in patients with covid-19 (9). - written informed consent. the protocol will be explained to the patient in front of a nurse who will act as a legal witness by signing the document on behalf of the patient. -

- need for oro-tracheal intubation and/or invasive mechanical ventilation at the start of the study. - ast/alt with values greater than 5 times normal levels. - neutrophils < 1.500 cell/mmc. - platelets < 50.000 cell/mmc. - sepsis or pneumonia documented by other pathogens than sars-cov-2. - existence of any life-threatening comorbidity or any other medical condition that, in the investigator's opinion, makes the patient unsuitable for inclusion. - inability to obtain informed consent. - positivity for hbv, hcv or tuberculin test serology. - pregnancy. - use of other previous or concomitant biological treatments. patients in concomitant treatment with other biologicals that may interfere will be excluded: tocilizumab, canakinumab, tnfalfa inhibitors, jakiinibs - severe renal dysfunction (estimated glomerular filtration rate ≤ 30 ml / min / 1.73 m2) or receive continuous renal replacement therapy, hemodialysis or peritoneal dialysis. - uncontrolled hypertension (sitting systolic blood pressure > 180 mmhg or diastolic blood pressure > 110 mmhg). - administration of plasma from convalescent patients who have recovered from sars-cov-2 infection. - history of hypersensitivity or allergy to any component of the study drug. - enrollment in another concurrent intervention clinical trial, or intake of an investigational medication within three months or 5 half-lives prior to inclusion in this study, if deemed to interfere with the objectives of this study as assessed by the investigator. - predictable inability to cooperate with given instructions or study procedures.

2

Fundacion Miguel Servet

18

80

Spain

Severe disease at enrollment

6: Severe disease at enrollment

179

Time to mechanical ventilation to assess the effect of anakinra in addition to standard treatment on the need for mechanical ventilation in patients with severe COVID-19 and CSS pneumonia.;Number of patients not requiring mechanical ventilation to assess the effect of anakinra in addition to standard treatment on the need for mechanical ventilation in patients with severe COVID-19 and CSS pneumonia.;Treatment success, defined as number of patients not requiring mechanical ventilation to assess the effect of anakinra in addition to standard treatment on the need for mechanical ventilation in patients with severe COVID-19 and CSS pneumonia.;Stay in ICU and hospitalization to assess the effect of anakinra in addition to standard treatment on the need for mechanical ventilation in patients with severe COVID-19 and CSS pneumonia.;Time to oxygen saturation normalization to assess the effect of anakinra in addition to standard treatment on the need for mechanical ventilation in patients with severe COVID-19 and CSS pneumonia.

None

Phase 2/Phase 3

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