ABSTRACT
Background: Recent studies suggest that baricitinib added to dexamethasone may reduce mortality in hospitalized COVID-19 patients requiring supplemental oxygen Methods: In a multicenter open-label, pragmatic, randomized clinical trial in 25 hospitals in Spain we included symptomatic participants with SARS-CoV-2 detected by PCR or antigenic test, with a creatinine clearance >60 mL/min, > 60 years or younger if they had at least two comorbidities (hypertension, obesity, diabetes, cirrhosis, chronic neurologic disease, active cancer, heart failure, coronary heart disease or COPD). Participants were initially randomized to receive or not tenofovir disoproxil fumarate/emtricitabine (TDF/FTC). At any moment during the trial participants with room air 02 saturation < 95% and at least one increased inflammatory biomarker could be randomized to dexamethasone (D) or dexamethasone plus baricitinib (DB). Primary outcome was 28 days mortality. Secondary outcomes were disease progression (increase of O2 requirements, mechanical ventilation or increase in medical therapy: steroid dose, need for starting tocilizumab) Results: Out of the 355 participants included in the trial 287 (80.8%) were randomized to D (n=142) or DB (n=145), 264 (91.9%) simultaneously with the TDF/FTC randomization and 23 (8.1%) later on. Median age 67 years (IQR 62, 73), male (65.5%), with median 8 days of symptoms (IQR 5-10), 28.6% with ≤ 5 days of symptoms, 100% hospitalized, 31.6% with one and 38.7% with ≥ 2 comorbidities (most common: 35.9% hypertension, 9.4% diabetes, 1.7 % obesity), 14.3% receiving remdesivir and 49.1% TDF/FTC. Endpoints in participants treated with D vs. those treated with DB favored DB without achieving statistical significance: mortality 4.9%/2.1%, disease progression 27.5%/24.8%, mechanical ventilation (invasive or noninvasive) 25.4%/23.4%, days since randomization until discharge (median [IQR]) 7 [5, 12]/7 [5, 13.5], discharge before 28 days 89%/94.2%. By Cox regression Hazard Ratio (95% CI) of 28-day mortality was 0.51 (0.13-2.06) for participants treated with DB. Serious adverse events occurred in 9.9%/9.7% of participants treated with D or DB respectively. Adverse events leading to B discontinuation occurred in 3.45% of participants. Conclusion: In this clinical trial of high-risk patients with COVID-19 all disease outcomes favored baricitinb added to dexamethasone but differences did not reach statistical significance. Overall mortality was unexpectedly low.
ABSTRACT
Infection with the SARS coronavirus type 2 (COVID-19) has a variety of presentations, with little data on the evolution of affected patients in Argentina. This is a retrospective and observational study of patients with virological confirmation of coronavirus treated during the months of March to May in a private third-level university hospital in Buenos Aires. O ne hundred and fifty-five adult patients were included, of which 30.3% attended only for a swab;59.4% were admitted to the hospital and 10.3% were hospitalized at home with daily telephone follow-up. Fifty-four point two percent of participants were women and the median age was 35 years (ICQ 29 to 50). About 59.3% of patients had some risk factor, including age (65 years old or more), underlying chronic disease, were health workers or personnel/residents in a nursing home. The most frequent symptom was fever (75.9%), followed by cough (65.7%), and odyno phagia (48.2%). Globally, 93.5% experienced some symptoms while 17.6% of the participants presented some symptoms but without fever. Chest tomographies were performed to 5 patients. Their chest radiograph was normal or non-diagnostic. Fourteen patients required intensive therapy and 6 of them required mechanical ventilation, 4 of them died. The remaining 2 patients were referred to chronic care centers. No patient with home hospitalization required admission to hospital or died. While this observation is encouraging, it will need to be confirmed with new studies.