COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05293210

Maria Carranza, MD

mariadecarranza@gmail.com

2022-03-24

Not recruiting

RCT

Randomized

Parallel

Open label

unclear

Treatment

inclusion criteria: patients admitted with sars-cov-2 (covid19) pneumonia confirmed by antigenic test or pcr age ≥ 18 yrs. pcr ≥ 66 mg/l and ≤150 mg/l at inclusion or pandemic score at admission > 200 with pcr 9.7-149 mg/l at inclusion. who scale level 4, with need for oxygen therapy in ng ≥ 1 lpm to maintain saturation ≥ 94%. onset of symptoms ≤ 10 days before the date of inclusion. after having received verbal and written information about the study, the patient must submit the signed and dated informed consent before performing any activity related to the study.

patients with respiratory distress criteria at the time of randomization, understood as need for ocnaf/vmni/vmi (levels 5 and 6 of the who scale) or o2 saturation ≤ 92% and/or fr ≥ 30 despite oxygen in ng at 4 liters. patients with allergy or contraindication to the use of systemic corticosteroids. patients with severe asthma or chronic pulmonary pathology with home oxygen requirements and active treatment with corticosteroids. patients on chronic corticosteroid treatment. use of corticosteroids daily in the 15 days prior to hospital admission. indication of corticosteroid use due to other clinical conditions of the patient (e.g., septic shock). pregnant or actively breastfeeding women patients with suspected or confirmed bacterial, fungal, or viral infection other than sars-cov-2 itself at the time of randomization patients with confirmed past or latent tuberculosis infection prior to inclusion. patients with known hiv infection with cd4 below 500 cells/mm3 or on active treatment with protease inhibitors or boosters such as cobicistat or ritonavir. patients with active oncologic processes in the last year or in active treatment with chemotherapy. patients with life expectancy < 3 months at inclusion due to clinical conditions other than sars-cov-2 pneumonia. patients with expected death in the following 48-72 hours. patients included in another clinical trial.

2

Hospital Universitario Infanta Leonor

18

100

None

Moderate disease at enrollment

3: Moderate disease at enrollment

200

Evaluate if there is a decrease in the proportion of patients who develop respiratory distress

None

Phase 3

[{"arm_notes": "nan", "treatment_id": 400, "treatment_name": "Dexamethasone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]