COVID-19 InfectionNCT04582903
Send-In Sample Collection for Comprehensive Analyses of Innate and Adaptive Immune Responses During Acute COVID-19 and Convalescence
An observational study of COVID-19 Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19). The global outbreak of COVID-19 is a major public health problem. COVID-19 causes a wide range of symptoms. These symptoms range from mild breathing problems to life-threatening problems or death. Read more about this study
- Who is it for?
- Ages 1 day to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Infection
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2020to 31 Jan 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: We plan to enroll up to 500 total participants in this protocol, including up to 300 patients with SARS-CoV-2 infection and 200 other participants (patient relatives and individuals who remain uninfected despite heavy or extensive COVID-19 exposure in the workplace or home environment). Health care providers worldwide will contact the study staff to request enrollment of patients and/or their relatives. Additionally, investigators may refer patients from other clinical studies.
Who may be able to join
- Participants enrolled onto this protocol must meet all of the following criteria:
- Aged 0-99 years (including viable neonates).
- Meets one of the following criteria:
- Patient with a known or suspected diagnosis of infection (past or current) with SARS-CoV-2 or an emerging or re-emerging respiratory virus, typically but not always supported by a positive PCR test for viral RNA;
- Individual who has remained uninfected with negative virus serologies despite heavy or extensive exposure to the emerging or re-emerging respiratory virus in the workplace or home environment; or
- Biological relative of a participant being studied under this protocol. Relatives may be biological mother, father, siblings, children, grandparents, aunts, uncles, or first cousins.
Show all 9Show fewer
- For individuals considered for enrollment as uninfected individuals and biological relatives, able to provide informed consent.
- Willing to allow genetic testing.
- Willing to allow storage of samples and data for future research.
Who cannot join
- Individuals meeting any of the following criteria will be excluded from study participation:
- 1. Any condition that, in the opinion of the investigator, contraindicates participation in this study.
- Since patients can be concurrently infected with multiple respiratory viruses, positive testing for other viruses such as rhinovirus, influenza virus, etc., does not exclude an individual from study participation where there remains a high clinical suspicion of infection with the emerging or re-emerging respiratory virus of interest despite negative testing for it.
- Co-enrollment guidelines: Participants may be co-enrolled in other studies; however, study staff should be notified of co-enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Niaid/Lcim
Rockville, Maryland, 20892
Helen Su, M.D. Ph. D, 301-451-8783, hsu@niaid.nih.gov
About this study
Official title: Send-In Sample Collection for Comprehensive Analyses of Innate and Adaptive Immune Responses During Acute Infections With, and Convalescence From, Emerging or Re-emerging Respiratory Viruses
Background:
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19). The global outbreak of COVID-19 is a major public health problem. COVID-19 causes a wide range of symptoms. These symptoms range from mild breathing problems to life-threatening problems or death. Some people have no symptoms. This study aims to learn how acute and late immune responses to COVID-19 lead to different outcomes. The immune system is the body s defense against germs, including viruses, that invade the body.
Read more
Objective:
To characterize the immune responses during and after SARS-CoV-2 infection and determine if there is any relationship to clinical course and outcome.
Eligibility:
People ages 0 99 who have confirmed or suspected SARS-CoV-2 infection, people who are not infected despite heavy exposure, and relatives of enrolled participants.
Design:
This is a sample collection protocol to receive send-in biological specimens for exploratory studies, including gene testing. Participants will not be seen at the NIH for study visits.
Study staff will talk with participants health care providers to screen them for the study. Participants enrolled into the protocol will send samples and clinical information at least once and more often if the participant has COVID-19. All participants will provide blood samples and possibly stool. We may also ask for left over specimens from any medical procedures completed as part of medical care. The study staff will also request participants health care providers to complete a survey to collect demographic and medical data. Some of this information may need to be provided directly by the participant.
Pregnant individuals are invited to participate and may be asked to give cord blood samples after delivery. Study findings that affect participants health may be shared with their health care provider. Depending on findings, participants may be contacted to take part in other NIH studies.
Read the detailed description
Study Description:
This is a prospective sample collection protocol to receive send-in biological samples (e.g., blood, saliva, stool, urine, and leftover clinically collected samples) for exploratory studies to characterize the immune response to coronavirus disease 2019 (COVID-19) or other emerging or re-emerging respiratory viruses. Participants will not be seen at the NIH for study visits. Under this protocol, samples will be collected longitudinally from patients with confirmed or suspected severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or other emerging or re-emerging respiratory viruses and sent to the NIH for research evaluations. Additionally, samples will be collected from uninfected patients and patient relatives. Testing will be performed to improve understanding of host immune responses to these viruses, including but not limited to genetic, molecular, and proteomic testing. Findings relevant to participants' health and medical care may be returned to them and their referring health care providers or study teams.
Objectives:
Primary Objective:
To achieve genetic, immunologic, molecular, and virologic characterization of the host immune responses during and after infection with SARS-CoV-2 or other emerging or re-emerging respiratory viruses, which will be correlated with clinical course and outcome data.
Endpoints:
Primary Endpoints:
- Identification of genetic variants that are associated with either severe/lethal disease or resistance to infection with SARS-CoV-2 or other emerging or re-emerging respiratory viruses.
- Characterization of the dynamic changes of innate and adaptive immune responses acutely and during convalescence after infection with SARS-CoV-2 or other emerging or re-emerging respiratory viruses.
- Measurement of proinflammatory/anti-inflammatory cytokines, including the interferon (IFN) signature response, produced acutely and during convalescence after infection with SARS-CoV-2 or other emerging or re-emerging respiratory viruses.
- Characterization of serological responses against SARS-CoV-2, other viruses or microbiota, and host antigens.
- Survey of other potential blood proteomic biomarkers of disease.
- Characterization of intrapatient SARS-CoV-2 or other emerging or re-emerging virus genetic variation and evolution during infection and convalescence.
- Conditions
- COVID-19 Infection
- Keywords
- severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Repository, Pandemic, Genetics, Proteomics, Natural History
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Biological Relative | Biological relative of a participant being studied under this protocol. Relatives may be biological mother, father, siblings, children, grandparents, aunts, uncles, or first cousins | |
| Confirmed or Suspected SARS-CoV-2 infection | Patient with a known or suspected diagnosis of SARS-CoV-2 infection (past or current), typically but not always supported by a positive PCR test for viral RNA | |
| Exposed but Uninfected | Individual who has remained uninfected with negative SARS-CoV-2 serologies despite heavy or extensive COVID-19 exposure in the workplace or home environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of the dynamic changes of innate and adaptive immune responses during SARS CoV 2 infection and convalescence.
These endpoints were chosen to provide in depth molecularmeasurements of a wide variety of innate and adaptive host immuneresponses to a novel pathogen in heterogenous patients. This is anexploratory hypothesis generating study to identify findings for validation in future studies. These endpoints are needed to better understand pathogenic mechanisms, improve prognostic tools, optimize existing therapies, and identify new targets for treatment.
Measured: End of Study
Identification of genetic variants that are associated with either severe/lethal COVID-19 or resistance to SARS CoV 2 infection.
These endpoints were chosen to provide in depth molecular measurements of a wide variety of innate and adaptive host immune responses to a novel pathogen in heterogenous patients. This is an exploratory hypothesis generating study to identify findings for validation in future studies. These endpoints are needed to better understand pathogenic mechanisms, improve prognostic tools, optimize existing therapies, and identify new targets for treatment.
Measured: End of Study
Measurement of proinflammatory/anti inflammatory cytokines produced during SARS CoV 2 infection and convalescence, including the IFN signature response.
These endpoints were chosen to provide in depth molecular measurements of a wide variety of innate and adaptive host immune responses to a novel pathogen in heterogenous patients. This is an exploratory hypothesis generating study to identify findings for validation in future studies. These endpoints are needed to better understand pathogenic mechanisms, improve prognostic tools, optimize existing therapies, and identify new targets for treatment.
Measured: End of Study
Survey of other potential blood proteomic biomarkers of disease.
These endpoints were chosen to provide in depth molecular measurements of a wide variety of innate and adaptive host immune responses to a novel pathogen in heterogenous patients. This is an exploratory hypothesis generating study to identify findings for validation in future studies. These endpoints are needed to better understand pathogenic mechanisms, improve prognostic tools, optimize existing therapies, and identify new targets for treatment.
Measured: End of Study
Characterization of serological responses against SARS CoV 2, other viruses or microbiota, and host antigens.
These endpoints were chosen to provide in depth molecular measurements of a wide variety of innate and adaptive host immune responses to a novel pathogen in heterogenous patients. This is an exploratory hypothesis generating study to identify findings for validation in future studies. These endpoints are needed to better understand pathogenic mechanisms, improve prognostic tools, optimize existing therapies, and identify new targets for treatment.
Measured: End of Study
Characterization of intrapatient SARS-CoV-2 genetic variation and evolution during infection and convalescence.
These endpoints were chosen to provide in depth molecular measurements of a wide variety of innate and adaptive host immune responses to a novel pathogen in heterogenous patients. This is an exploratory hypothesis generating study to identify findings for validation in future studies. These endpoints are needed to better understand pathogenic mechanisms, improve prognostic tools, optimize existing therapies, and identify new targets for treatment.
Measured: End of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start13 Oct 2020
- Primary completion31 Aug 2030 (estimated)
- Study completion31 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVID-19 InfectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Helen C Su, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04582903
- Sponsor's protocol ID
- 10000044
- Other IDs
- 000044-I
- Status last verified
- 2 Oct 2026
- First submitted
- 9 Oct 2020
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This study is part of a multi-institute project at the NIH and we may share de-identified information to the various participating institutes and investigators as needed.
Publications
Casanova JL, Su HC; COVID Human Genetic Effort. A Global Effort to Define the Human Genetics of Protective Immunity to SARS-CoV-2 Infection. Cell. 2020 Jun 11;181(6):1194-1199. doi: 10.1016/j.cell.2020.05.016. Epub 2020 May 13.
PubMed 32405102Burbelo PD, Riedo FX, Morishima C, Rawlings S, Smith D, Das S, Strich JR, Chertow DS, Davey RT, Cohen JI. Sensitivity in Detection of Antibodies to Nucleocapsid and Spike Proteins of Severe Acute Respiratory Syndrome Coronavirus 2 in Patients With Coronavirus Disease 2019. J Infect Dis. 2020 Jun 29;222(2):206-213. doi: 10.1093/infdis/jiaa273.
PubMed 32427334Gabutti G, d'Anchera E, Sandri F, Savio M, Stefanati A. Coronavirus: Update Related to the Current Outbreak of COVID-19. Infect Dis Ther. 2020 Jun;9(2):241-253. doi: 10.1007/s40121-020-00295-5. Epub 2020 Apr 8.
PubMed 32292686
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Send-In Sample Collection for Comprehensive Analyses of Innate and Adaptive Immune Responses During Acute Infections With, and Convalescence From, Emerging or Re-emerging Respiratory Viruses
- ClinicalTrials.gov ID
- NCT04582903
- Acronym / sponsor ID
- 10000044
- Conditions
- COVID-19 Infection
- Keywords
- severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Repository, Pandemic, Genetics, Proteomics, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 31 Aug 2030 (estimated)
- Study completion
- 31 Jan 2031 (estimated)
- First posted
- 12 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19). The global outbreak of COVID-19 is a major public health problem. COVID-19 causes a wide range of symptoms. These symptoms range from mild breathing problems to life-threatening problems or death. Some people have no symptoms. This study aims to learn how acute and late immune responses to COVID-19 lead to different outcomes. The immune system is the body s defense against germs, including viruses, that invade the body.
Objective:
To characterize the immune responses during and after SARS-CoV-2 infection and determine if there is any relationship to clinical course and outcome.
Eligibility:
People ages 0 99 who have confirmed or suspected SARS-CoV-2 infection, people who are not infected despite heavy exposure, and relatives of enrolled participants.
Design:
This is a sample collection protocol to receive send-in biological specimens for exploratory studies, including gene testing. Participants will not be seen at the NIH for study visits.
Study staff will talk with participants health care providers to screen them for the study. Participants enrolled into the protocol will send samples and clinical information at least once and more often if the participant has COVID-19. All participants will provide blood samples and possibly stool. We may also ask for left over specimens from any medical procedures completed as part of medical care. The study staff will also request participants health care providers to complete a survey to collect demographic and medical data. Some of this information may need to be provided directly by the participant.
Pregnant individuals are invited to participate and may be asked to give cord blood samples after delivery. Study findings that affect participants health may be shared with their health care provider. Depending on findings, participants may be contacted to take part in other NIH studies.
Detailed description
Study Description:
This is a prospective sample collection protocol to receive send-in biological samples (e.g., blood, saliva, stool, urine, and leftover clinically collected samples) for exploratory studies to characterize the immune response to coronavirus disease 2019 (COVID-19) or other emerging or re-emerging respiratory viruses. Participants will not be seen at the NIH for study visits. Under this protocol, samples will be collected longitudinally from patients with confirmed or suspected severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or other emerging or re-emerging respiratory viruses and sent to the NIH for research evaluations. Additionally, samples will be collected from uninfected patients and patient relatives. Testing will be performed to improve understanding of host immune responses to these viruses, including but not limited to genetic, molecular, and proteomic testing. Findings relevant to participants' health and medical care may be returned to them and their referring health care providers or study teams.
Objectives:
Primary Objective:
To achieve genetic, immunologic, molecular, and virologic characterization of the host immune responses during and after infection with SARS-CoV-2 or other emerging or re-emerging respiratory viruses, which will be correlated with clinical course and outcome data.
Endpoints:
Primary Endpoints:
- Identification of genetic variants that are associated with either severe/lethal disease or resistance to infection with SARS-CoV-2 or other emerging or re-emerging respiratory viruses.
- Characterization of the dynamic changes of innate and adaptive immune responses acutely and during convalescence after infection with SARS-CoV-2 or other emerging or re-emerging respiratory viruses.
- Measurement of proinflammatory/anti-inflammatory cytokines, including the interferon (IFN) signature response, produced acutely and during convalescence after infection with SARS-CoV-2 or other emerging or re-emerging respiratory viruses.
- Characterization of serological responses against SARS-CoV-2, other viruses or microbiota, and host antigens.
- Survey of other potential blood proteomic biomarkers of disease.
- Characterization of intrapatient SARS-CoV-2 or other emerging or re-emerging virus genetic variation and evolution during infection and convalescence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Biological Relative | – | –Biological relative of a participant being studied under this protocol. Relatives may be biological mother, father, siblings, children, grandparents, aunts, uncles, or first cousins |
| Confirmed or Suspected SARS-CoV-2 infection | – | –Patient with a known or suspected diagnosis of SARS-CoV-2 infection (past or current), typically but not always supported by a positive PCR test for viral RNA |
| Exposed but Uninfected | – | –Individual who has remained uninfected with negative SARS-CoV-2 serologies despite heavy or extensive COVID-19 exposure in the workplace or home environment |
Who may qualify
- Ages
- 1 day to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We plan to enroll up to 500 total participants in this protocol, including up to 300 patients with SARS-CoV-2 infection and 200 other participants (patient relatives and individuals who remain uninfected despite heavy or extensive COVID-19 exposure in the workplace or home environment). Health care providers worldwide will contact the study staff to request enrollment of patients and/or their relatives. Additionally, investigators may refer patients from other clinical studies.
Key inclusion criteria (9 listed)
- Aged 0-99 years (including viable neonates).
- Meets one of the following criteria:
- For individuals considered for enrollment as uninfected individuals and biological relatives, able to provide informed consent.
- Willing to allow genetic testing.
- Willing to allow storage of samples and data for future research.
Key exclusion criteria (4 listed)
- Individuals meeting any of the following criteria will be excluded from study participation:
- 1. Any condition that, in the opinion of the investigator, contraindicates participation in this study.
- Since patients can be concurrently infected with multiple respiratory viruses, positive testing for other viruses such as rhinovirus, influenza virus, etc., does not exclude an individual from study participation where there remains a high clinical suspicion of infection with the emerging or re-emerging respiratory virus of interest despite negative testing for it.
- Co-enrollment guidelines: Participants may be co-enrolled in other studies; however, study staff should be notified of co-enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characterization of the dynamic changes of innate and adaptive immune responses during SARS CoV 2 infection and convalescence.
Time frame: End of Study
These endpoints were chosen to provide in depth molecularmeasurements of a wide variety of innate and adaptive host immuneresponses to a novel pathogen in heterogenous patients. This is anexploratory hypothesis generating study to identify findings for validation in future studies. These endpoints are needed to better understand pathogenic mechanisms, improve prognostic tools, optimize existing therapies, and identify new targets for treatment.
Identification of genetic variants that are associated with either severe/lethal COVID-19 or resistance to SARS CoV 2 infection.
Time frame: End of Study
These endpoints were chosen to provide in depth molecular measurements of a wide variety of innate and adaptive host immune responses to a novel pathogen in heterogenous patients. This is an exploratory hypothesis generating study to identify findings for validation in future studies. These endpoints are needed to better understand pathogenic mechanisms, improve prognostic tools, optimize existing therapies, and identify new targets for treatment.
Measurement of proinflammatory/anti inflammatory cytokines produced during SARS CoV 2 infection and convalescence, including the IFN signature response.
Time frame: End of Study
These endpoints were chosen to provide in depth molecular measurements of a wide variety of innate and adaptive host immune responses to a novel pathogen in heterogenous patients. This is an exploratory hypothesis generating study to identify findings for validation in future studies. These endpoints are needed to better understand pathogenic mechanisms, improve prognostic tools, optimize existing therapies, and identify new targets for treatment.
Survey of other potential blood proteomic biomarkers of disease.
Time frame: End of Study
These endpoints were chosen to provide in depth molecular measurements of a wide variety of innate and adaptive host immune responses to a novel pathogen in heterogenous patients. This is an exploratory hypothesis generating study to identify findings for validation in future studies. These endpoints are needed to better understand pathogenic mechanisms, improve prognostic tools, optimize existing therapies, and identify new targets for treatment.
Characterization of serological responses against SARS CoV 2, other viruses or microbiota, and host antigens.
Time frame: End of Study
These endpoints were chosen to provide in depth molecular measurements of a wide variety of innate and adaptive host immune responses to a novel pathogen in heterogenous patients. This is an exploratory hypothesis generating study to identify findings for validation in future studies. These endpoints are needed to better understand pathogenic mechanisms, improve prognostic tools, optimize existing therapies, and identify new targets for treatment.
Characterization of intrapatient SARS-CoV-2 genetic variation and evolution during infection and convalescence.
Time frame: End of Study
These endpoints were chosen to provide in depth molecular measurements of a wide variety of innate and adaptive host immune responses to a novel pathogen in heterogenous patients. This is an exploratory hypothesis generating study to identify findings for validation in future studies. These endpoints are needed to better understand pathogenic mechanisms, improve prognostic tools, optimize existing therapies, and identify new targets for treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Background: PubMed 32405102Casanova JL, Su HC; COVID Human Genetic Effort. A Global Effort to Define the Human Genetics of Protective Immunity to SARS-CoV-2 Infection. Cell. 2020 Jun 11;181(6):1194-1199. doi: 10.1016/j.cell.2020.05.016. Epub 2020 May 13.
- Background: PubMed 32427334Burbelo PD, Riedo FX, Morishima C, Rawlings S, Smith D, Das S, Strich JR, Chertow DS, Davey RT, Cohen JI. Sensitivity in Detection of Antibodies to Nucleocapsid and Spike Proteins of Severe Acute Respiratory Syndrome Coronavirus 2 in Patients With Coronavirus Disease 2019. J Infect Dis. 2020 Jun 29;222(2):206-213. doi: 10.1093/infdis/jiaa273.
- Background: PubMed 32292686Gabutti G, d'Anchera E, Sandri F, Savio M, Stefanati A. Coronavirus: Update Related to the Current Outbreak of COVID-19. Infect Dis Ther. 2020 Jun;9(2):241-253. doi: 10.1007/s40121-020-00295-5. Epub 2020 Apr 8.
- Individual participant dataSharing planned: Undecided. This study is part of a multi-institute project at the NIH and we may share de-identified information to the various participating institutes and investigators as needed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Helen C Su, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Margaret A Abaandou ((301) 332-4870, margaret.abaandou@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of the dynamic changes of innate and adaptive immune responses during SARS CoV 2 infection and convalescence. (time frame: End of Study). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04582903, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.