COVID-19 Observational Clinical Studies


Since March 2020, the Department of Defense’s (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense’s (JPEO-CBRND) Joint Project Lead for CBRND Enabling Biotechnologies (JPL CBRND EB) and the Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) have collaborated with public and private sector organizations to support several COVID-19 observational clinical studies. The studies, funded through a partnership with the Defense Health Agency (DHA), support the DOD and its partners to understand SARS-CoV-2 and its progression. The studies support the DOD’s and its partners’ efforts to become better prepared for not only COVID-19, but also future public health emergencies.

The studies JPL CBRND EB has led for the past two and a half years established a network of clinical sites around the country and the globe. These efforts allow the DOD and its academic and private sector clinical partners (e.g., Duke University, Johns Hopkins University and others) to react quickly to future pandemics by testing, evaluating and understanding the medical countermeasures at the DOD’s disposal. Beyond the development and expanded use of the mRNA vaccine, there are new technologies that were put to the test through these observational studies, one of the objectives of the observational studies includes enhancing clinical evaluation while mitgating public health risks of disease spread in infected participants.

 To make this possible, the studies are pushing the decentralization of clinical trials through a device known as Tasso. This device allows for remote blood sample collection, preventing germ spread at testing sites and among infected patients, a feature that is particularly desirable during the ongoing COVID-19 pandemic or with other highly transmissible viruses. Over 10,000 Tasso devices are deployed at military treatment facilities (MTFs), Veterans Affairs (VA) facilities, and civilian clinical sites with ongoing analyses of the device’s effectiveness.

JPL CBRND EB uses other devices that are also advantageous for warfighters in austere environments. The studies test biomarker devices to help medical personnel make informed decisions. New technologies are able to monitor patient vitals, which helps medical professionals make informed decisions and determine appropriate treatment courses, including if a current countermeasure treatment is working, or if patients need additional intervention in a hospital or other setting. Although these devices are being tested for warfighters, they have a lot of potential to be used for civilians too.

COVID-19 testing is a significant component of the observational clinical studies. For example, the longitudinal study of COVID-19 Vaccine Effectiveness and Immunogenicity in Active-Duty Military Population (VIRAMP) evaluates post-vaccination protection against symptomatic, asymptomatic and breakthrough COVID-19 cases. VIRAMP uses twice-weekly home saliva testing to determine immunity to different COVID-19 strands. With nearly 1,000 participants enrolled in the study, the evaluation period is following participants for up to two years to determine vaccination effectiveness and the impact of the emerging variants on the vaccines.
These COVID-19 observational studies are still ongoing. Aside from having a better understanding of the protection that the various vaccines provide against COVID-19, the studies also aim to build clinical networks worldwide to respond quickly to the next pandemic or future biothreat.

The studies aim to test medical countermeasures more rapidly than in the past and in various types of environments. Therefore, no matter the setting, medical professionals will be prepared to treat patients at home and in areas lacking resources needed during a pandemic.
The response effort to COVID-19 and any future pandemics do not stop with these observational studies. In April 2022, JPEO-CBRND collaborated with JUST EvoTech Biologics (JUST) to provide the United States government priority access to the JUST facility for the next seven years. This effort aims to strengthen the DOD and thus the Nation’s rapid response capabilities. 

Rapid response capabilities were established and used during the COVID-19 response to manufacture monoclonal antibodies for use in clinical trials. The innovative continuous manufacturing processes implemented at JUST, in collaboration with DOD, enabled an over sevenfold increase in the number of doses produced compared in the same period using standard manufacturing processes. In a rapid response context, this means
fielding sevenfold or more doses out of the first production lot—a highly significant achievement and capability. This increase in productivity will also result in reduced cost per dose for routinely produced antibody medical countermeasures.

JPEO-CBRND’s Generative Unconstrained Intelligent Drug Engineering (GUIDE), an artificial intelligence machine-learning program, initiated a retargeting campaign in December of 2021, and began establishment of a revolutionary integrated computational drug development toolset. Even with early versions of molecular design tools, GUIDE was able to modify a clinical stage antibody that had lost effectiveness to the Omicron variant, and accomplished the redesign in under three weeks. The tools enable not only a retargeting to the new variant, but also maintained critical product quality attributes to improve safety and manufacturability.

One of the retargeted antibody candidates, Omicron-199, has proven effective against all COVID-19 variants that have emerged to-date. In mid-July 2022, the GUIDE team transferred the Omicron-199 material to AstraZeneca for additional testing and potential product development work. The antibody could be one of the first computationally retargeted antibodies to be further developed. This is promising and may lead to regulatory engagements with the U.S. Food and Drug Administration, and if approved, it could lead to future clinical trials. In short, the JPEO-CBRND’s JPL CBRND EB team may have helped uncover a potential antibody that could be effective against all SARS-CoV-2 variants thus far, which could also be an essential countermeasure for the continuing global COVID-19 response.

Written by:

Daniel Critchfield

Booz Allen Hamilton

Alex Hillman, JPEO Public Affairs Officer