Weekly Review: Clinical Studies – September 8, 2020

Clinical Characteristics

In this case series of 91 children who tested positive for COVID-19 in Korea, 22% were asymptomatic. These children were tested for COVID-19 when they had a history of close contact with confirmed cases. Only 8.5% of symptomatic cases were diagnosed at the time of symptom onset, while 66.2% had unrecognized symptoms before diagnosis and 25.4% developed symptoms after diagnosis; SARS-CoV-2 RNA was detected for a mean of 17.6 days overall and 14.1 days in asymptomatic cases. The take home point from this article is that symptom screening fails to identify most COVID-19 cases in children, and SARS-CoV-2 RNA in children is detected for over two weeks.


In the CoDEX randomized clinical trial in Brazil, researchers examined whether intravenous dexamethasone plus standard care was better than standard care alone when increasing the number of days alive and free from mechanical ventilation. Within 299 patient, they found that those treated with dexamethasone plus standard care has significantly more days alive and free from mechanical ventilation during the first 28 days of COVID-19 disease, compared to standard care alone (6.6; 95% CI, 5.0-8.2 days vs 4.0; 95% CI, 2.9-5.4 days; difference, 2.26; 95% CI, 0.2-4.38; P = .04) .

In a the CAPE COD randomized clinical trial of 149 patients in France, low-dose hydrocortisone did not significantly reduce treatment failure (defined as death or persistent respiratory support with mechanical ventilation or high-flow oxygen therapy) on day 21 compared to placebo groups (42.1% vs 50.7%, respectively). Of note, this study was stopped early by the data and safety monitoring board, so it was likely underpowered.

In a bayesian randomized clinical trial of 403 multinational patients,  treatment with a 7-day fixed-dose course of hydrocortisone or shock-dependent dosing of hydrocortisone was compared with no hydrocortisone when looking to improve 21-day organ support-free days. Treatment with 7-day fixed-dose hydrocortisone resulted in 93% odds probability of superiority (and the shock-dependent dosing resulted in 80%) compared to the no-hydrocortisone group. The study was stopped early after results from another trial (the RECOVERY Trial) were released.

Vaccine Development

This Phase 1-2 Trial of a SARS-CoV-2 recombinant nanoparticle vaccine (composed of trimeric full length SARS-COV-2 spike glycoproteins and Matrix-M1 adjuvant) found that it is safe and it elicited immune responses that exceeded levels in COVID-19 convalescent serum.

|2020-09-05T21:35:06-04:00September 8th, 2020|COVID-19 Literature|Comments Off on Weekly Review: Clinical Studies – September 8, 2020

About the Author: Megan McHenry

Megan McHenry
Megan S. McHenry, MD, MS, FAAP is a pediatrician and an Assistant Professor of Pediatrics in the Ryan White Center for Pediatric Infectious Disease and Global Health at Indiana University School of Medicine. Dr. McHenry's research focuses on early childhood development in children living in resource-limited settings. This work is frequently aligned with community-engaged research and dissemination and implementation science frameworks. She primarily conducts research in collaboration with the Academic Model for Providing Access to Healthcare (AMPATH) Research Network in Kenya. Dr. McHenry currently has a career development award through the National Institutes of Health to develop a neurodevelopmental screening program for children born to HIV-infected mothers in Kenya. Dr. McHenry is also the Director of Pediatric Global Health Education and a co-Director of the Morris Green Physician-Scientist Development Program at Indiana University School of Medicine. In additional to global health lectures, she also educates residents and students on early childhood development, basic biostatistical techniques, research methodologies, and research ethics. She mentors multiple pediatric fellows, residents, and medical students interested in early childhood development within global contexts.

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