Pathogenesis, Treatment and Prevention of Emerging Infectious Diseases

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Principal Investigator: H. Clifford  Lane
Organization: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
Fiscal Year: 2021
Award: $155,251
Funding agency: National Institute of Allergy and Infectious Diseases

Research in this project is currently focused on six areas.  These are: characterization of the survivors of the anthrax attacks of 2001; characterization of emerging respiratory infections including SARS, COVID-19, and influenza; evaluation of experimental vaccines and treatments for Ebola virus; characterizing the long-term sequelae of Ebola virus infection; evaluating experimental therapeutics for COVID-19; characterizing the long-term sequelae of SARS-CoV-2 infection. 

The anthrax study has enrolled a cohort of volunteers who are currently undergoing an extensive diagnostic evaluation. 

The Prevail 4 trial enrolled 38 men who had survived Ebola virus infection and had persistent evidence of Ebola virus RNA in their semen and randomized them to receive remdesivir at a dose of 100 mg/d for five days. While no differences in RNA persistence were noted a the end of the infusions; patients randomized to remdesivir had more negative samples in follow-up (96% vs.  81%; p=0.041)

In the first evaluation of an anti-viral therapy in the COVID-19 therapeutic trial ACTIV-3, 314 hospitalized patients with COVID-19 were randomized to receive an intravenous infusion of bamlanivimab (a monoclonal antibody directed toward the spike protein of SARS CoV-2) or placebo.  An interim futility analysis performed on day 5 based upon a seven-category ordinal scale showed no difference between the two arms, leading to termination of the bamlanivimab arm of the trial.  The study has gone on to randomize patients to the Brii monoclonal antibody cocktail, the Vir antibody and the Astra-Zeneca combination of antibodies.

In collaboration with scientists from Argentina, 333 hospitalized adult patients with COVID-19 were randomized 2:1 to receive convalescent plasma or placebo.  The primary outcome was clinical status at 30 days according to an ordinal scale.  No significant differences were noted between the plasma group and placebo controls.

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