Four NIH COVID-19 Clinical Research Programs Launched to Combat the Pandemic

The National Institutes of Health (NIH) has launched four clinical studies to advance the approval of new medicines for COVID-19. With some of the greatest scientific, clinical and regulatory minds and some of the deepest resources in the world, NIH has an important role in advancing new life-saving drugs to combat the coronavirus pandemic.

NIH is a BioHealth Capital Region (BHCR) anchor institution and a cornerstone for scientific research and biomedical advancements across the globe. Proximity to both NIH and FDA are often noted by life science industry leaders when discussing the benefits of locating their headquarters, a satellite office or a biomanufacturing facility in the region.  The BHRC boasts a host of other bio hub assets, including the University of Maryland, Johns Hopkins, George Mason and other regional universities that have strong biotech programs.

In addition to NIH’s leadership role in advancing biomedical solutions to COVID-19, the region has seen a strong response from the regional industry, including Vaccine Progress from 8 BioHealth Capital Region Companies and 7 Diagnostics Companies Leading the Fight against COVID-19.

The following is a rundown of the trials NIH is currently sponsoring.

First COVID-19 Treatment Trial

NIH clinical trial of remdesivir to treat COVID-19 begins – Feb 25th

In what seems like a lifetime ago, on February 25th, NIH announced a clinical trial of Remdesivir, developed by Gilead Sciences Inc.

At the time, this trial was the first of its kind to test an experimental treatment for COVID-19 in the U.S. The clinical trial, which is being run at the University of Nebraska Medical Center in Omaha, included hospitalized adults with the coronavirus. The first participant was an American who had been on a cruise ship docked in Japan and volunteered to participate in the trial after being quarantined.

The trial regulatory sponsor is the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the NIH. Remdesivir had been previously tested in humans as a treatment for EBOLA and had shown promise after being tested animal models as a possible treatment for Middle East Respiratory Syndrome or MERS and Severe Acute Respiratory Syndrome or SARS. Remdesivir clinical trials are also being conducted in China. 

Early trial results from Gilead on a very small patient population with serious COVID-19 illness can be read here.

First COVID-19 Vaccine Trial Announced

NIH clinical trial of investigational vaccine for COVID-19 begins — March 16th

NIH, headquartered in Bethesda, Maryland, and the National Institute of Allergy and Infectious Disease (NIAID) within NIH, have funded a Phase I clinical trial into a potential COVID-19 vaccine. The trial, which is being conducted by the Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle, began on March 16th and is expected to last six weeks. KPWHRI is part of NIAID’s Infectious Disease Research Consortium; the trial will test the mRNA-1273 COVID-19 vaccine developed by NIAID researchers in collaboration with Moderna, Inc.

45 healthy adult volunteers between the ages of 18 and 55 will be part of the study. Two doses of the vaccine will be given 28 days apart and volunteers will be asked to return for follow up visits between doses and for one year following the second dose. If all goes according to plan, the Phase I component of the vaccine trial should conclude toward the end of April 2020.

Hydroxychloroquine Treatment Clinical Trial Announced

NIH clinical trial of hydroxychloroquine, a potential therapy for COVID-19, begins — April 9th

Hydroxychloroquine (HCQ), has been a controversial topic in the news lately. Approved for medical use in the U.S. in 1955, HCQ has been used to treat malaria, rheumatoid arthritis and systemic lupus erythematosus. Research has begun to investigate HCQ as a possible treatment for COVID-19.

On April 9th, NIH announced a clinical trial called the ORCHID Study whose first participants are enrolled in Tennessee at Vanderbilt University Medical Center. The Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network of the National Heart, Lung, and Blood Institute (NHLBI), which is part of NIH, is conducting the trial.

According to a recent NIH press release, “The blinded, placebo-controlled randomized clinical trial aims to enroll more than 500 adults who are currently hospitalized with COVID-19 or in an emergency department with anticipated hospitalization. All participants in the study will continue to receive clinical care as indicated for their condition.  Those randomized to the experimental intervention will also receive hydroxychloroquine.”

Due to the increased interest in HCQ as a possible therapy for COVID-19 there have been reports of shortages of the drug for patients who have been using it for other medical conditions. In addition, HCQ, while being used mostly by frontline medical workers that currently have few options, has dangerous side effects and has not yet been proven safe and efficacious against COVID-19 through an official clinical trial. Side effects can include cardiac arrhythmias, seizures, dermatological reactions and hypoglycemia.

The ORCHID trial will attempt to gather the HCQ data necessary to more fully understand the drug’s safety and efficacy profile in the context of COVID-19 treatment.

First Serological Survey Announced

NIH begins study to quantify undetected cases of coronavirus infection — April 10th

NIH has commenced a new study to determine how many U.S. adults with no confirmed SARS-Cov-2 infection history have antibodies to the virus. 

This study is addressing the current health crisis by providing a view into how many people in American communities have been infected without even knowing it. Called a “serosurvey,” the study will collect and analyze blood samples from 10,000 volunteers; the data will then be used to inform the creation of epidemiological models and help to map the spread of previously undetected coronavirus cases in the U.S.

A host of NIH groups will participate in the study, including the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Biomedical Imaging and Bioengineering (NIBIB), with additional support from the National Center for Advancing Translational Sciences (NCATS) and the National Cancer Institute (NCI).

According to a recent NIH press release on the topic, Anthony S. Fauci, M.D., NIAID Director, stated that the study “…will give us a clearer picture of the true magnitude of the COVID-19 pandemic in the United States by telling us how many people in different communities have been infected without knowing it, because they had a very mild, undocumented illness or did not access testing while they were sick. These crucial data will help us measure the impact of our public health efforts now and guide our COVID-19 response moving forward.”

Individuals interested in volunteering for this study can contact [email protected].

Looking Forward

These recent COVID-19 related study and trial announcements showcase how NIH is working hand-in-hand with institutions and organizations across the U.S. to combat the coronavirus pandemic.

We expect many more COVID-19-related NIH announcements across the coming weeks and months. Through NIH’s collaborative efforts, its top scientific talent and unmatched pool of research resources, COVID-19 therapeutics and vaccine research  is accelerating while preserving the regulatory standards required to provide safe and efficacious medicines to the American public.