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1.
Clin Appl Thromb Hemost ; 27: 10760296211051712, 2021.
Article in English | MEDLINE | ID: covidwho-1495925

ABSTRACT

BACKGROUND: Since the beginning of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) pandemic, there have been many reports of increased incidence of venous thromboembolism and arterial events as a complication. OBJECTIVE: To determine the incidence of symptomatic thrombotic events (TEs) in patients hospitalized for SARS-CoV2 disease (coronavirus 19 [Covid-19]). METHODS: A retrospective single-center cohort study with adult patients with a positive reverse transcriptase-polymerase chain reaction (rt-PCR) for SARS-CoV2, included from the date of diagnosis of Covid-19 and followed for 90 days or until death. RESULTS: A total of 1621 patients were included in this study. The median age was 73 years (interquartile range25th-75th [IQR] 53-87 years) and 57% (913) were female. Overall mortality was 21.6% (348). The overall incidence of symptomatic TEs within 90 days of diagnosis was 1.8% (30 of 1621) occurring in 28 patients, including an incidence of pulmonary embolism of 0.9% (15, 95% confidence interval [CI] 0.60%-1.6%), deep venous thrombosis of 0.61% (10, 95% CI 0.2%-1%), ischemic stroke of 0.25% (4, 95% CI 0.09%-0.65%), and ischemic arterial events of 0.06% (1, 95% CI 0.008%-0.43%). No acute coronary syndrome events were recorded. The incidence of symptomatic TEs was significantly lower in the general ward than in intensive care units (1.2% vs 5.7%; p < .001). The median time since positive rt-PCR for SARS-CoV2 to symptomatic TE was 22.5 days (IQR 19-43 days). There was no significant difference in the proportion of patients receiving (53.6%) and not receiving thromboprophylaxis (66.5%) and the development of TEs. CONCLUSION: The overall incidence of symptomatic TEs among these patients was lower than the incidence previously reported.


Subject(s)
Arterial Occlusive Diseases/epidemiology , COVID-19/epidemiology , Pulmonary Embolism/epidemiology , Thromboembolism/epidemiology , Venous Thrombosis/epidemiology , Aged , Aged, 80 and over , Argentina/epidemiology , Arterial Occlusive Diseases/blood , Arterial Occlusive Diseases/diagnosis , COVID-19/blood , COVID-19/diagnosis , Female , Humans , Incidence , Ischemic Stroke/blood , Ischemic Stroke/diagnosis , Ischemic Stroke/epidemiology , Male , Middle Aged , Patient Admission , Pulmonary Embolism/blood , Pulmonary Embolism/diagnosis , Retrospective Studies , Thromboembolism/blood , Thromboembolism/diagnosis , Time Factors , Venous Thrombosis/blood , Venous Thrombosis/diagnosis
2.
N Engl J Med ; 384(7): 619-629, 2021 02 18.
Article in English | MEDLINE | ID: covidwho-990095

ABSTRACT

BACKGROUND: Convalescent plasma is frequently administered to patients with Covid-19 and has been reported, largely on the basis of observational data, to improve clinical outcomes. Minimal data are available from adequately powered randomized, controlled trials. METHODS: We randomly assigned hospitalized adult patients with severe Covid-19 pneumonia in a 2:1 ratio to receive convalescent plasma or placebo. The primary outcome was the patient's clinical status 30 days after the intervention, as measured on a six-point ordinal scale ranging from total recovery to death. RESULTS: A total of 228 patients were assigned to receive convalescent plasma and 105 to receive placebo. The median time from the onset of symptoms to enrollment in the trial was 8 days (interquartile range, 5 to 10), and hypoxemia was the most frequent severity criterion for enrollment. The infused convalescent plasma had a median titer of 1:3200 of total SARS-CoV-2 antibodies (interquartile range, 1:800 to 1:3200). No patients were lost to follow-up. At day 30 day, no significant difference was noted between the convalescent plasma group and the placebo group in the distribution of clinical outcomes according to the ordinal scale (odds ratio, 0.83; 95% confidence interval [CI], 0.52 to 1.35; P = 0.46). Overall mortality was 10.96% in the convalescent plasma group and 11.43% in the placebo group, for a risk difference of -0.46 percentage points (95% CI, -7.8 to 6.8). Total SARS-CoV-2 antibody titers tended to be higher in the convalescent plasma group at day 2 after the intervention. Adverse events and serious adverse events were similar in the two groups. CONCLUSIONS: No significant differences were observed in clinical status or overall mortality between patients treated with convalescent plasma and those who received placebo. (PlasmAr ClinicalTrials.gov number, NCT04383535.).


Subject(s)
Antibodies, Neutralizing/blood , COVID-19/therapy , Immunoglobulin G/blood , Pneumonia, Viral/therapy , SARS-CoV-2/immunology , Aged , Aged, 80 and over , Blood Component Transfusion , COVID-19/complications , COVID-19/mortality , Disease Progression , Double-Blind Method , Female , Hospitalization , Humans , Immunization, Passive , Kaplan-Meier Estimate , Male , Middle Aged , Pneumonia, Viral/etiology , Pneumonia, Viral/mortality , Severity of Illness Index , COVID-19 Serotherapy
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