COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05578391

Not reported

Not reported

2022-10-13

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: patients with sars-cov-2 infection, confirmed by any validated microbiological technique, and with one or more symptoms associated with covid-19 with ≤5 days of evolution and with an oxygen saturation ≥93% breathing room air. in addition, the patients had to present some risk factor for severe disease: chronic heart failure (nyha ≥ 2) arterial hypertension under pharmacological treatment chronic lung disease: copd (bronchitis, emphysema or chronic obstruction) with dyspnoea at least on moderate exertion, or moderate-severe asthma (that required inhaled corticosteroids to control symptoms or had received systemic corticosteroids during the last year due to decompensation) chronic renal failure (glomerular filtration rate <60 ml/min/1.73 m², by ckd- ild) diabetes mellitus requiring pharmacological treatment or obesity grade ≥ i (bmi ≥30 kg/m2). patients ≥65 years were included, regardless of other risk factors.

duration of symptoms >5 days dyspnoea at rest need for supplemental oxygen to maintain o2 saturation >93% solid neoplastic or haematologic disease (except skin cancer) with active treatment in the last 3 months before the onset of symptoms patients under chronic corticosteroid treatment (equivalent to prednisone 10 mg/d for at least 28 days) or immunosuppressive treatment decompensated liver cirrhosis participation in another clinical trial history of hypersensitivity to haematological derivatives pregnancy or lactation, ast/alt >5 times the upper limit of normal or at baseline in patients with chronic liver disease any condition that in the opinion of the investigator limits participation in the study. patients who had received monoclonal antibodies against sars-cov-2

2

Fundacin Biomedica Galicia Sur

18

100

Spain

Mild disease at enrollment

1: Mild disease at enrollment

61

Requirement for oxygen therapy to maintain saturation >93%

None

Phase 2

[{"arm_notes": "", "treatment_id": 322, "treatment_name": "Convalescent plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]