| Study name |
Outpatient treatment of COVID‐19 with early pulmonary corticosteroids as an opportunity to modify the course of the disease (TOCICOVID) |
| Methods |
Trial design: open (phase IV) RCT Sample size: 60 Setting: inpatient Language: Spanish, English Number of centres: no information Type of intervention (treatment/prevention): treatment |
| Participants |
Inclusion criteria
Patient > 18 years old Ability to grant consent Bilateral pneumonia caused by SARS‐CoV‐2 without response to the treatment used according to local protocol. This is defined as persistence of fever (above 37.5ºC without other focus) and respiratory worsening (more dyspnoea, more cough, oxygen therapy at increasing doses, worsening of the degree of respiratory distress according to the PaO2/FiO2 ratio in categories 'mild, moderate or serious') or absence of improvement with respect to the previous state Persistently elevated inflammatory markers, among which must be met: ferritin > 1000 ng/mL and/or D‐dimer > 1500 ng/mL and/or IL‐6 > 40 pg/mL
Exclusion criteria
Pregnancy and lactation Terminal situation or life expectancy < 30 days in the judgement of the researcher Allergy or intolerance to any of the drugs under study or to any of the excipients of the preparations (e.g. polysorbate 80) Non‐tolerable interaction of the study drugs with some essential chronic medication of the patient ALT/AST > 5 x ULN Severe neutropenia (< 500 cells / mm3 Plateletpenia < 50,000/mm3 Sepsis (clinical suspicion of active infection at another level with a value on the qSOFA scale of ≥ 2 points) or septic shock (need for vasopressors to maintain a mean arterial pressure ≥ 65 mmHg with a lactate > 2 mmol/L, despite adequate volume replacement Another active infection at any level Complicated diverticulitis or intestinal perforation Kidney failure with estimated glomerular filtration < 30 mL/min Liver failure (Child B onwards) Previous use (during the acute process or as chronic medication for another reason) of medication with potential effect in this phase of the disease (Janus kinase inhibitors, interleukin‐1 inhibitors, other immunosuppressants or immunomodulators that, in the investigator's judgement, could have an effect on the disease based on pathophysiological criteria or previous research or started up in this same period) Be included in another clinical trial Patients who, due to their current situation, their baseline situation or other aspects, in the opinion of the researcher, are not considered candidates to enter the study
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| Interventions |
Details of intervention: tocilizumab
Treatment details of control group (e.g. dose, route of administration): methylprednisolone, 331 mg, IV
Concomitant therapy: no information |
| Outcomes |
Primary study outcome: respiratory situation at 24 hours, 3 and 7 days based on PaO2/FiO2 ratio that graduates respiratory distress from mild (200 to 300), moderate (100 to 200) and severe (< 100). In addition, it will include: presence of dyspnoea and grade according to the New York Health Association (NYHA) scale, presence of respiratory work and respiratory rate (FR) |
| Starting date |
22 July 2020 |
| Contact information |
IIS BIODONOSTIA 943006288 |
| Notes |
Recruitment status: ongoing
Prospective completion date: 20‐month estimated duration of trial
Date last update was posted: 20 April 2020
Sponsor/funding: IIS BIODONOSTIA |
