VITAL: Vital Innovative Treatments and Antivirals for Long Covid Act 2024

(for research into curing, treating, and preventing Long Covid)

This proposed U.S. Congressional Law creates a federally funded program for grant-funded research into Long Covid. Grant funds are provided for:

• clinical research programs and for research centers doing basic and clinical research;
• training in advanced diagnostic, prevention, and treatment methods for Long Covid;
• developing and disseminating Long Covid clinical care model protocols to physicians;
• establishing fellowships and training programs for health professionals and health personnel to develop skills in epidemiology, surveillance, testing, counseling, education, information, and laboratory analysis relating to Long Covid;
• research grants in local communities to plan and conduct clinical trials of experimental treatments for Long Covid with new drugs including antivirals, and with off-label uses of existing drugs;
• research grants in local communities to plan and conduct clinical trials of experimental diagnostics and biomarkers including viral load tests, and;
• long-term research into treatments developed from knowledge of the genetic nature of the etiologic agent for Long Covid.

The law establishes a priority to develop and expand clinical trials of treatments and therapies for Long Covid to include clinical trials for women, infants, children, and minorities.

The law also requires continuous data collection, to be published at least once yearly,  on:

• the incidence of cases of Long Covid in the United States;
• the incidence of cases of infection with Covid-19/SARS-CoV-2, the etiologic agent for Long Covid; and,
• domestic and international transmission patterns.

Data will include demographic characteristics of individuals infected, and data on specific subpopulations at risk of infection.

This law establishes a research infrastructure that includes:

• the Office of Long Covid Research at the National Institutes of Health, with clinical evaluation units with inpatient beds at the Clinical Center of the National Institutes of Health to conduct clinical evaluations of experimental treatments for Long Covid;
• a Long Covid Clinical Research Review Committee to advise on appropriate research on clinical treatment of Long Covid;
• coordination of activities between the Health and Human Services Secretary, the Director of the National Institutes of Health, and the Director of the Office of Long Covid Research to develop and expand clinical trials of treatments and therapies for infection with the etiologic agent for Long Covid, which may also include large-scale development and preclinical screening, production, or distribution of specialized biological materials and other therapeutic substances for research relating to Long Covid;
• funds for repairing, operating and obtaining equipment for research labs; and,
• grants for conducting research outside the United States by qualified foreign professionals that can reasonably be expected to benefit the people of the United States, and for collaborative research involving American and foreign participants as well as training of American scientists abroad and foreign scientists in the United States.

The Long Covid Clinical Research Review Committee will advise on appropriate research on clinical treatment of Long Covid and will consist of:

• physicians whose clinical practice includes a significant number of patients with Long Covid, and,
• physicians who are also Long Covid patients.

This committee will:

• advise on research into drugs for preventing and treating Long Covid, including drugs not yet FDA-approved which are being used as off-label treatments by Long Covid patients.
• review and report on publicly and privately supported research into clinical treatments for Long Covid, including research on drug treatments, diagnostics, biomarkers, antivirals, and viral load tests;
• issue reports and advisories to health care professionals; and,
• conduct studies and meetings to determine recommendations among physicians on clinical treatment for Long Covid, including drug treatments.

To facilitate the attendance at committee meetings of physicians with Long Covid, mitigations for airborne infectious disease are required at committee meeting locations, and live virtual attendance options for meetings are also required for every meeting.

Based on recommendations of the Long Covid Clinical Research Review Committee, the Health and Human Services Secretary will:

• encourage investigational use of new drugs in drug trials including antivirals, and establish a program for evaluation of drugs used as off-label treatments by Long Covid patients, for which assessment of treatments will include viral load testing,  scanning,  and/or other types of viral load assessment technology use as a measured parameter;
• establish appropriate scientific and ethical guidelines for conducting these evaluations in consultation with physicians whose clinical practice includes a significant number of Long Covid patients; physicians who are Long Covid patients;  individuals with Long Covid; and other individuals with appropriate expertise or experience, including experts in airborne disease mitigation;
• conduct a study of Long Covid mortality rates among various risk groups, and among individuals with varying ability to afford health care services to be completed no later than 18 months after the passage of the Act;
• conduct a study of how vaccines for COVID-19 have impacted individuals with Long Covid and report on these impacts, and how vaccines could be improved to be safely provided to people with Long Covid;
• request reports on emergency use authorizations (EUAs) needed to be put into place to expedite research and clinical treatment for diagnostics, viral load tests, antivirals, immunotherapies, immunomodulators, peptides, and other existing and novel drug  treatments for people with Long Covid;
• conduct a study and provide recommendations on how a program could be put into place for people with Long Covid to donate their bodies to science for use in research studying Long Covid, and how such a program could disseminate samples to researchers; and,
• request reports on how establishing consortia that combine businesses with nonprofits could enhance and expedite resource sharing and development of vaccines and drugs for the prevention and treatment of Long Covid, including through a variety of avenues such as Compassionate Use programs, due no less than 1 year after passage of the Act.

The Health and Human Services Secretary will also:

• make grants to public and nonprofit private entities/organizations for developing clinical care model protocols for treating individuals with Long Covid;
• make grants to, and enter into contracts with, public and nonprofit private entities for planning, establishing, strengthening, and providing operating support for centers doing basic and clinical research, and training in advanced diagnostic, prevention, and treatment methods for Long Covid;
• prioritize and expedite clinical research trials for antivirals, to include viral load testing such as transcriptomics, and provide funding for extended length of antiviral clinical trials beyond days or weeks in order to assess results over months to a year;
• establish a program of testing, research and education to assess the safety of the blood supply and organs for transplants;
• establish testing to prevent the acquisition of transplant organs that are infected with the etiologic agent for Long Covid; and,
• ensure that clinical research programs include as research subjects women, children, and minorities as appropriate.

The Director of the National Institutes of Health will make grants to public and nonprofit entities/organizations to plan and conduct clinical trials in the community for experimental treatments for Long Covid by providing funds for:

• assistance to community-based organizations and community health centers for retaining appropriate medical supervision;
• for assisting with administration, data collection and record management;
• for conducting training of community physicians, nurse practitioners, physicians’ assistants and other health professionals for the purpose of conducting clinical trials; and
• assistance for community-based demonstration project clinical trials to provide access to the entire scope of communities affected with the etiologic agent for Long Covid, including minorities, women, children, and individuals who are asymptomatic.

Mitigations for airborne infectious disease are required for all research with Long Covid patients receiving grant funds, and consent documentation must fully disclose to Long Covid patients whether researchers and healthcare providers who will be in contact with patients will wear N95 masks and use mitigations such as HEPA filtration and upper-air UV:

• Clean air mitigations required of all grantees when interacting with individuals and families with Long Covid  include: masking by all research and clinical treatment staff, service and care providers with an N95 respirator; N95 respirators provided free of charge to all staff and to individuals and families seeking care and services or participating in research; and HEPA filtration devices and/or Corsi-Rosenthal boxes in full operation at all service, research and treatment locations to provide clean air mitigation during service, research and treatment activities.

The law also creates a program in the Department of Health and Human Services to provide and disseminate information on research, treatment, and prevention of Long Covid to include:

• a web site and toll-free telephone communications to provide medical and technical information on Long Covid to to health care professionals, allied health care providers, and to professionals providing emergency health services;
• a clearinghouse of information which develops and obtains educational materials, model curricula, and information on methods for reducing the transmission of the etiologic agent for Long Covid;
• information on preventing exposure to and transmission of the etiologic agent for Long Covid in health care settings with immune compromised Long Covid patients;
• information on Long Covid research, clinical trials, and treatment databanks;
• creation of a databank of information with results of research on Long Covid conducted in the United States and in other countries and information on Long Covid experimental treatments, clinical trials, and results including potential toxicities or adverse effects, and;
• making the databank available to researchers, physicians, journalists, organizations for Long Covid research, treatment, and patient advocacy, Long Covid patients, and other appropriate individuals in the United States and other countries,

To help take action and lobby to adopt the HEAL legislation, please sign the following letter and be sure to personalize it with your story: Tell Bernie Sanders to Enact the HEAL Legislation Proposal for Long Covid »