Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Viral Infections in Healthy and Immunocompromised Hosts

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01306084
Recruitment Status : Recruiting
First Posted : March 1, 2011
Last Update Posted : October 30, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Brief Summary:

Background:

- Viral infections are an important cause of illness and death in hospitalized patients as well as outpatients. New strains of viruses may appear and infect both healthy people and those with weak immune systems. A better understanding of these new virus strains (such as SARS-CoV-2, the virus that causes COVID-19) may help to control and prevent these infections. In particular, some viral infections that are less problematic in healthy persons can be life threatening in persons with weak immune systems, and viruses may be able to evolve more rapidly in persons with weak immune systems and therefore develop resistance to existing treatments. Researchers are interested in collecting samples and information from otherwise healthy persons or persons with weak immune systems to study the effects of viruses and their development.

Objectives:

- To collect samples and data from individuals who have been exposed to or have contracted viral infections.

Eligibility:

  • Individuals of all ages who have been diagnosed with a viral infection are suspected to have a viral infection, or have been in close contact with someone with a suspected or actual viral infection that is of interest to investigators in the Laboratory of Infectious Diseases.
  • Healthy persons and persons with weak immune systems (immunocompromised individuals) are eligible to participate.

Design:

  • Participants will be pre-screened to determine if they meet the eligibility criteria for the trial.
  • If eligible, evaluation may include a medical chart review, a history and physical examination, review of clinical reports from outside hospitals and laboratories, and review of tissue biopsies.
  • Study procedures may include collection of blood, urine, saliva, nasal fluid sampling, throat swabs, stool, and genital swabs. For participants who have specimens collected as part of their medical care (e.g. wound swabs, spinal tap, bronchoscopy, liver biopsy etc.), researchers may use leftover specimens from the clinical laboratory for testing.
  • Specimens may be collected up to 4 times per week during the first 2 weeks after enrollment, and then as many as 2 times per week for up to 2 years. Some participants may be asked to continue providing specimens if there is concern for relapse or recurrence of the infection.
  • Treatment is not offered under this study.

Condition or disease
Anogenital Herpes COVID-19 Herpes Labialis

Detailed Description:
Viral infections are an important cause of morbidity and mortality in hospitalized patients as well as out-patients. New strains of viruses may appear and cause epidemics in healthy persons or immunocompromised persons. A better understanding of these new virus strains may help to control and prevent these infections. Some viral infections that would otherwise be asymptomatic or cause mild disease can be life threatening in immunocompromised persons. Immunocompromised persons often shed high titers of virus for prolonged periods of time. In the absence of a potent immune system, viruses may evolve more rapidly in their hosts. Therefore, analysis of sequential virus specimens from these patients can provide information on virus evolution, including how resistance to antiviral agents can develop. In addition, higher titers of virus may be associated with virus mutants that are more adapted to grow in cell culture. In this protocol we will obtain specimens containing viruses from otherwise healthy or immunocompromised patients over sequential periods of time to study their nucleic acid sequences, sensitivity to antiviral agents, cell types infected by the virus, and ability to grow in cell culture. In some cases we weill review tissue biosies or clinical reports from outside laboratories to assist with the diagnosis of virus-associated diseases. We will also record the patient s signs and symptoms, note results of any pertinent laboratory work-up, and in some cases, obtain blood to measure immune responses, isolate antibodies, or virus-specific T cells, or to look for viremia. This study should provide further understanding on how viruses evolve in their natural hosts, how they become resistant to antiviral agents, how antibody responses evolve to viruses, and might allow some currently uncultivatable viruses to be grown in cell culture.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Viral Infections in Healthy and Immunocompromised Hosts
Actual Study Start Date : March 5, 2011

Group/Cohort
1
NIH campus workers who have recently recovered from COVID-19
2
Clinical Center health care workers and ancillary staff who have close patient contact and possible exposures to SARS-CoV-2
3
Healthy and immunocompromised subjects who have or are suspected to have a viral infection
4
Healthy and immunocompromised subjects exposed to someone who has a viral infection or is suspected of having a viral infection



Primary Outcome Measures :
  1. Sample collection, analysis of immune function, or review of tissue bx or clinical rpts from outside labs in designated pop. w/ viral, suspected, or recovered from a viral infection or a close contact of people w/or suspected to have a viral inf... [ Time Frame: open-ended ]
    January 2031



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Healthy or immunocompromised subjects with viral infections, or suspected of having a viral infection, or recovering from a viral infection, or a close contact of someone who has had or is suspected to have had an acute or chronic viral infection. Subjects may either be at the Clinical Center or samples may be sent to LID directly from subjects enrolled at non-NIH sites.
Criteria
  • INCLUSION CRITERIA:

    1. The protocol is open to people of all ages:

      i. Only patients greater than or equal to 2 years of age can be enrolled at the Clinical Center

      ii. Patients who are < 2 years old may be enrolled only remotely and will not be seen at the Clinical Center.

    2. Must have (or be suspected of having) a viral infection, that is of interest to LID investigators. Alternatively, must be a close contact of someone who has (or is suspected of having) a viral infection that is of interest to LID investigators.
    3. Adults who are unable to provide initial consent may be enrolled providing procedures per Human Research Protections Program (HRPP) standard operation procedure (SOP) 14E have been followed.

EXCLUSION CRITERIA:

  1. Patients who are unable to safely undergo study procedures and tests.
  2. Patients unwilling to have samples collected and stored for future use.

    INCLUSION OF VULNERABLE PARTICIPANTS:

    -Children:

    Children younger than 2 years of age will be enrolled only remotely from non-NIH medical facilities and will not be seen at the Clinical Center, because children of this age are susceptible to viral infections, some of which are more likely to occur in this very young population or could be more severe. Title 45 of the United States Code of Federal Regulations (CFR) Part 46 Subpart D and (OHRSPHRPP SOP 14D) will be followed to comply with research involving children. The proposed research poses a risk no greater than that encountered with blood tests or other minimally invasive tests ordered as part of a routine history and physical examination. The PI will ensure that appropriate permission from each child s parent(s) or guardian has been obtained for participation in this study.

    -Pregnant Women:

    Pregnant women are eligible to participate in this study as they are susceptible to viral infections, some of which may be more severe in this patient population. This study provides an opportunity to learn more about viral infections in pregnant women. This information may be meaningful in informing disease severity, clinical practice for treating pregnant women, or in leading to new treatments for this population. This information cannot be gained without the participation of pregnant women. The primary procedure performed under this protocol is a blood draw but other procedures may be performed and are considered minimal risk in clinical practice. No procedures that would affect a developing fetus or affect a baby through breastfeeding are performed in the protocol.

    -Decisionally Impaired Adults:

    Adults who are unable to provide initial informed consent are eligible to enroll. Also adults who lose the ability to provide on-going consent subsequent to giving initial consent may continue to participate. These adults are susceptible to viral infections and we can learn about viral infections that may occur in this population. Institutionalized adults will not be enrolled. The procedures utilized are clinically considered to be of minimal risk


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01306084


Contacts
Layout table for location contacts
Contact: Krista S Gangler, R.N. (301) 761-6437 krista.gangler@nih.gov
Contact: Jeffrey I Cohen, M.D. jcohen@niaid.nih.gov

Locations
Layout table for location information
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Layout table for investigator information
Principal Investigator: Jeffrey I Cohen, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
Additional Information:
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01306084    
Other Study ID Numbers: 110109
11-I-0109
First Posted: March 1, 2011    Key Record Dates
Last Update Posted: October 30, 2020
Last Verified: October 21, 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
SARS-CoV-2
Respiratory Infections
Norovirus
Adenovirus
Coronavirus
Viral Infection
Respiratory Viruses
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Virus Diseases
Herpes Labialis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Skin Diseases, Viral
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Skin Diseases, Infectious
Skin Diseases