Effect of COVID-19 during pregnancy: Studying the maternal and neonatal outcomes and assessing the placental changes related to SARS-CoV-2 (preprint)

Abstract: Background: Pregnant females affected with COVID-19 are reported to have poorer disease outcomes as compared to non-pregnant females of a similar age group. COVID-19 may lead to adverse changes in the placenta, which needs to be studied. Methods: This is a case series of 63 pregnant women hospitalized with COVID-19 from May 2020 to February 2021.The primary outcomes were maternal death or complications. Results: 63 women were studied. 83.3% of women were in the age group of 26 to 35 years. 33% women had associated comorbidities. 68.3% of women tested positive in their third trimester, 15.9% and 11% tested positive in their second and first trimesters respectively. 73% women had mild disease and 27% women required oxygen support. 3/63 women died. One woman in the second and two women in the third trimester died respectively. Histopathological examination in 13 placentae (of 19 placentae examined) were suggestive of maternal and fetal malperfusion. Conclusion: Pregnant COVID-19 women may develop disease-related as well as obstetric complications.

Hydroxychloroquine Prophylaxis against Coronavirus Disease-19: Practice Outcomes among Health-Care Workers (preprint)

BackgroundSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a rapidly emerging virus responsible for the ongoing Covid-19 pandemic with no known effective prophylaxis. We investigated whether hydroxychloroquine(HCQ) could prevent SARS CoV-2 in healthcare workers(HCW) at high-risk of exposure. MethodThis voluntary observational study for the prevention and treatment of COVID-19 was conducted at a tertiary care center, from 12th June to 12th October 2020(total 16 weeks). All consented asymptomatic HCWs of CIMS hospital were administered 400 mg HCQ twice a day on day one followed by 400 mg once weekly to be taken with meals up to 16 weeks. Data collected included OPD registration, risk assessment, medical and family history (related to COVID), physical examination and vitals, pulse oximetry, ECG (pre and post HCQ), drug adherence, side effects, adverse drug reactions. ResultThe study enrolled 927 full-time, hospital-based HCWs ((including doctors, nurses, paramedical, lab technicians, sanitary workers and others), of whom 731(78.85%) initially started HCQ while 196 (21.14%) did not volunteer. The median age and weight of the study population was 27.5 years and 69.5 kg respectively. No major associated co-morbidities were present in these HCWs. There was an increased trend towards non adherence to HCQ with each proceeding week more so after week 11. Of the 731 HCWs taking HCQ a total of 167(22.8%) tested COVID positive at different intervals of time as against 30 HCW (15.3%) out of 196 not taking HCQ. The rate of COVID-19 positive was statistically significantly higher in the HCWs taking HCQ (p=0.0220; 95% CI: 1.14% to 12.94%), as compared to those not on HCQ. Thus HCQ was not prophylactically effective against COVID 19 infection. No participants in this study experienced grade 3 or 4 adverse events. No significant difference in the median of ECG changes in QTc between pre and post HCQ administration of 46 HCWs was observed. ConclusionsThis clinical study did not detect a reduction in SARS CoV-2 transmission with prophylactic administration of 400 mg/HCQ in HCWs. All participants who did contract SARSCoV-2 were either asymptomatic or had mild disease courses with full recoveries. All adverse events were self-limiting and no serious cardiovascular events were reported with use of HCQ. In the absence of robust data, it seems premature to recommend HCQ as a prophylactic panacea for COVID-19.

Remdesivir for the treatment of COVID-19 disease: A retrospective comparative study of patients treated with and without Remdesivir (preprint)

BackgroundRemdesivir (RDV) in coronavirus disease 2019 (COVID-19) has been found to be beneficial in patients with severe disease; however, its role in mild-moderate disease and its optimal timing need to be identified. ObjectiveTo assess the course of illness and final outcome in patients who received RDV at various stages of illness, and compare it to the non-RDV group. MethodsThis is a retrospective data analysis of 1262 COVID-19 patients hospitalized from May5, 2020 to August 31, 2020. The primary outcomes were progression to mechanical ventilation (MV) or death. Kaplan Meier survival analysis and log rank test were used for evaluating primary outcomes. Results398 patients comprised the RDV group and 260 patients comprised the non-RDV group. 2/3rd of patients were above 50 years of age in both the groups and 3/4th patients were male. Mortality rate was 5.8% in RDV group (10.4% in non-RDV group). Mortality rate was 3.6%, 4% and 16.7% when RDV was started within 5 days, 5 to 10 days and after 10 days of symptom onset respectively. Fewer patients in RDV group progressed to MV (4.0% v/s 8.2%). Earlier discharge occurred in RDV group. Use of supplemental oxygen was observed in 44.7% patients in RDV group (54.2% in non-RDV group). No significant adverse events were observed with RDV. Survival analysis showed that probability of event (death) was significant for patients with hypertension (HT) and/or diabetes mellitus (DM) in RDV group. ConclusionEarly initiation of RDV is associated with shorter hospital stay, lower mortality as well as reduced need for supplemental oxygen and mechanical ventilation.

A Comparative COVID 19 Characterizations and Clinical Course Analysis between ICU and Non ICU Settings (preprint)

Objective: With COVID-19 pandemic severely affecting India and Ahmedabad city being one accounting for half COVID cases, objective was to determine disease course and severity of in patients at a COVID care hospital. Design: A Clinical trial registry of India registered observational study (CTRI/2020/05/025247). Setting: Certified COVID hospital located in Ahmedabad, Gujarat, India. Participants: 549 COVID positive patients hospitalized between 15 th May to 10 th August, 2020 and treated in ICU and non ICU settings. Main Outcome Measure: Comparative analysis of demographic, clinical characteristics, investigations, treatment, complications and outcome of COVID patients in ICU and non ICU settings. Results: Of the 549 hospitalized COVID positive patients, 159 were admitted in ICU during disease course while 390 had ward admissions. Overall median age was 52 (1-86) years. The ICU group was older (>65years), with associated comorbidities like hypertension and diabetes (p<0.001); higher proportion of males (79.25%); with dyspnea as a major clinical characteristic and consolidation in lungs as a major radiological finding as compared to ward patients. C - reactive protein, D-Dimer and Ferritin were higher in ICU patients. Overall 50% females depicted elevated Ferritin levels. Steriods(92.45%)and tocilizumab (69.18%) were more frequently used for ICU patients . Remdesivir was prescribed to both ICU and non ICU patients. Favirapir was also a line of treatment for 25% of ICU patients. Convalescent plasma therapy was given to 7 ICU patients. Complications like acute kidney injury (13.84%), shock (10.69 %), sepsis and encephalopathy were observed in ICU patients. Overall mortality rate was 5.47 % with higher mortality among males in comparison to females (p<0.0001). Conclusion: About 29% of overall patients required ICU admission that was commonly elderly males. Chances of ICU admission were higher with baselines comorbidities (1.5 times) and dyspnea (3.4 times) respectively. A multi-specialty COVID care team and updated treatment protocols improves outcomes.