ABSTRACT
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.
ABSTRACT
Thirty-two adult female ASA I patients (American Society of Anesthesiologists' grading) undergoing voluntary termination of pregnancy (VTP) under general anaesthesia were randomly divided into three groups. Patients received 0.6 mg/kg pentazocine intravenously five minutes prior to induction of anaesthesia along with either isotonic saline, or promethazine 0.5 mg/kg or metoclopramide 0.2 mg/kg. Anaesthesia was induced with intravenous thiopentone and maintained with nitrous oxide in oxygen and boluses of thiopentone. Vomiting and sedation were scored at the end of anaesthesia, one hour later and at the time of discharge. The mean vomiting score was comparable in the three groups. Though the mean dose of thiopentone used was significantly less in the promethazine group, the sedation scores and the duration of stay in the clinic were comparable in all the groups. It is concluded that promethazine and metoclopramide in the doses used are ineffective as antiemetic agents in outpatient gynaecological patients.
