Clinical Updates

FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic which has been caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). FDA is committed to providing timely guidance to support response efforts to this pandemic. FDA is issuing this guidance to assist sponsors in the clinical development and licensure of vaccines for the prevention of COVID-19.

Association of Treatment Dose Anticoagulation with In-Hospital Survival Among Hospitalized Patients with COVID-19 | Feasibility and physiological effects of prone positioning in non-intubated patients with acute respiratory failure due to COVID-19 (PRON-COVID): a prospective cohort study | Effect of Dexamethasone in Hospitalized Patients with COVID-19 – Preliminary Report | Tocilizumab treatment for Cytokine Release Syndrome in hospitalized COVID-19 patients: survival and clinical outcomes

SARS-CoV-2 shedding and seroconversion among passengers quarantined after disembarking a cruise ship: a case series | Low-cost dexamethasone reduces death by up to one third in hospitalised patients with severe respiratory complications of COVID-19 (Press release) | Shedding of infectious virus in hospitalized patients with coronavirus disease-2019 (COVID-19): duration and key determinants

COVID-19 Vaccine Developers Search for Antibodies That ‘First Do No Harm’ | Consensus summary report for CEPI/BC March 12–13, 2020 meeting: Assessment of risk of disease enhancement with COVID-19 vaccines

A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19 | Predicting infectious SARS-CoV-2 from diagnostic samples | Physical distancing, face masks, and eye protection to prevent person-to-person transmission of SARS-CoV-2 and COVID-19: a systematic review and meta-analysis

Developing Covid-19 Vaccines at Pandemic Speed | Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial | Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis

Multisystem inflammatory syndrome in children and adolescents temporally related to COVID-19 | Cigarette smoke exposure and inflammatory signaling increase the expression of the SARS-CoV-2 receptor ACE2 in the respiratory tract

An outbreak of severe Kawasaki-like disease at the Italian epicentre of the SARS-CoV-2 epidemic: an observational cohort study | Preventing a Parallel Pandemic — A National Strategy to Protect Clinicians’ Well-Being | Triple combination of interferon beta-1b, lopinavir–ritonavir, and ribavirin in the treatment of patients admitted to hospital with COVID-19: an open-label, randomised, phase 2 trial

Arterial thromboembolic complications in COVID-19 in low risk patients despite prophylaxis | Association of Treatment With Hydroxychloroquine or Azithromycin With In-Hospital Mortality in Patients With COVID-19 in New York State | Observational Study of Hydroxychloroquine in Hospitalized Patients with Covid-19

Large-Vessel Stroke as a Presenting Feature of Covid-19 in the Young | Hyperinflammatory shock in children during COVID-19 pandemic | Interpreting Diagnostic Tests for SARS-CoV-2 | The Ecology of Being Human by Dickson Despommier