COVID-19 coronavirus research has overall low methodological quality thus far: case in point for chloroquine/hydroxychloroquine.

OBJECTIVES/BACKGROUND AND OBJECTIVES: Prior epidemics of high-mortality human coronaviruses, such as the acute respiratory syndrome coronavirus (SARS-CoV or SARS-1) in 2003, have driven the characterization of compounds that could be possibly active against the currently emerging novel coronavirus SARS-CoV-2 (COVID-19). Presently, no approved treatment or prophylaxis is available for COVID-19. We comment on the existing COVID-19 research methodologies in general and the published reporting. Given the media attention and claims of effectiveness, we chose chloroquine and hydroxychloroquine, in combination with azithromycin, as an area of COVID-19 research to examine. METHODS/STUDY DESIGN AND SETTING: MEDLINE and EMBASE electronic databases were searched from 2019 to present (April 3rd, 2020) using a mix of keywords such as COVID-19 and chloroquine and hydroxychloroquine. We also searched the largest clinical medicine preprint repository, medRxiv.org. RESULTS: We found 6 studies, 3 randomized control trials and 3 observational studies, focusing on chloroquine and hydroxychloroquine (with azithromycin). We critically appraised the evidence. CONCLUSION: We found that the COVID-19 research methodology is very poor in the area of chloroquine/hydroxychloroquine research. In screening the literature, we observed the same across COVID-19 research in relation to potential treatments. The reporting is very poor and sparse, and patient-important outcomes needed to discern decision-making priorities are not reported. We do understand the barriers to perform rigorous research in health care settings overwhelmed by a novel deadly disease. However, this emergency pandemic situation does not transform flawed methods and data into credible results. The adequately powered, comparative, and robust clinical research that is needed for optimal evidence-informed decision-making remains absent in COVID-19.

Vertical transmission risk of SARS-CoV-2 infection in the third trimester: a systematic scoping review.

BACKGROUND: Studies on COVID-19 infection in pregnancy thus far have largely focused on characterizing maternal and neonatal clinical characteristics. However, another evolving focus is assessing and mitigating the risk of vertical transmission amongst COVID-19-positive mothers. The objective of this review was to summarize the current evidence on the vertical transmission potential of COVID-19 infection in the third trimester and its effects on the neonate. METHODS: OVID MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trial (CENTRAL) were searched from January 2020 to May 2020, with continuous surveillance. RESULTS: 18 studies met the inclusion criteria, consisting of 157 mothers and 160 neonates. The mean age of the pregnant patients was 30.8 years and the mean gestational period was 37 weeks and 1 d. Currently, there is currently no conclusive evidence to suggest that vertical transmission of SARS-CoV-2 occurs. Amongst 81 (69%) neonates who were tested for SARS-CoV-2, 5 (6%) had a positive result. However, amongst these 5 neonates, the earliest test was performed at 16 h after birth, and only 1 neonate was positive when they were later re-tested. However, this neonate initially tested negative at birth, suggesting that the SARS-CoV-2 infection was likely hospital-acquired rather than vertically transmitted. 13 (8%) neonates had complications or symptoms. CONCLUSIONS: The findings of this rapid descriptive review based on early clinical evidence suggest that vertical transmission of SARS-CoV-2 from mother to neonate/newborn did not occur. Future studies are needed to determine the optimal management of neonates born to COVID-19-positive mothers.