RESUMEN
Infection with SARS-Cov-2 virus, is associated with significant morbidity and mortality, in addition to the economic burden it has put on the country. While waiting for a vaccine that gives adequate protection, it is necessary to understand the course of the infection and identify drugs that could reduce its impact. The results of this multicenter study involving 1035 hospitalized patients in Pune, identified diabetes, hypertension and low lymphocyte counts as predictors of mortality. There is also an indication that multiple comorbidities add to risk of severe disease and mortality. Data from metformin treated diabetics raises the possibility of considering repurposing of this drug in a larger study. It is also noted that Hydroxychloroquine, dexamethasone, azithromycin and remdesivir were associated with lower overall mortality. Diabetes and hypertension put Covid infected patients at greater risk of death, coexistence of both diseases further augment the risk, and must be aggressively treated.
RESUMEN
ObjectivesConvalescent plasma (CP) as a passive source of neutralizing antibodies and immunomodulators is a century-old therapeutic option used for the management of viral diseases. We investigated its effectiveness for the treatment of COVID-19. DesignOpen-label, parallel-arm, phase II, multicentre, randomized controlled trial. SettingThirty-nine public and private hospitals across India. ParticipantsHospitalized, moderately ill confirmed COVID-19 patients (PaO2/FiO2: 200-300 or respiratory rate > 24/min and SpO2 [≤] 93% on room air). InterventionParticipants were randomized to either control (best standard of care (BSC)) or intervention (CP + BSC) arm. Two doses of 200 mL CP was transfused 24 hours apart in the intervention arm. Main Outcome MeasureComposite of progression to severe disease (PaO2/FiO2< 100) or all-cause mortality at 28 days post-enrolment. ResultsBetween 22nd April to 14th July 2020, 464 participants were enrolled; 235 and 229 in intervention and control arm, respectively. Composite primary outcome was achieved in 44 (18.7%) participants in the intervention arm and 41 (17.9%) in the control arm [aOR: 1.09; 95% CI: 0.67, 1.77]. Mortality was documented in 34 (13.6%) and 31 (14.6%) participants in intervention and control arm, respectively [aOR) 1.06 95% CI: -0.61 to 1.83]. InterpretationCP was not associated with reduction in mortality or progression to severe COVID-19. This trial has high generalizability and approximates real-life setting of CP therapy in settings with limited laboratory capacity. A priori measurement of neutralizing antibody titres in donors and participants may further clarify the role of CP in management of COVID-19. Trial registrationThe trial was registered with Clinical Trial Registry of India (CTRI); CTRI/2020/04/024775.
