Acute and Long Term Effects of COVID-19 on Systemic InflammationNCT04401449
Cardiopulmonary Inflammation and Multi-System Imaging During the Clinical Course of COVID-19 Infection in Asymptomatic and Symptomatic Persons
An observational study of Acute and Long Term Effects of COVID-19 on Systemic Inflammation and Acute and Long Term Effects of COVID-19 on Lung Function, run by National Institutes of Health Clinical Center (CC) at 2 sites in United States.
Trial summary
Background: COVID-19 virus infection differs among people. Some people have no or mild symptoms. For others, COVID-19 is life threatening and causes damage to the body s organs. Researchers want to better understand the virus to learn how to kill it. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute and Long Term Effects of COVID-19 on Systemic Inflammation, Acute and Long Term Effects of COVID-19 on Lung Function, Acute and Long Term Effects of COVID-19 on Cardiac Function
- How many people
- 202 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 May 2020to 31 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: men or women, 18 - 80 years of age, a) within 1- 28 days (+/- 7 days) of documented COVID-19 infection for acute care (n=150) with subsequent follow-up during recovery (28 +/- 7 days to 12 weeks) and then during convalescence (Week 13 to 12 months - year 1), year 2 convalesecent phase and year 3 convalesecent phase. Each Phase visit can be done out of window as per PI discretion. OR b) if care for acute COVID-19 infections was given at an outside site, participants would be evaluated during recovery (28 +/- 7 days to 12 weeks, during convalescence (Week 13 to 12 months - year 1), year 2 - convalesecent phase and year 3 - convalesecent phase) Each Phase visit can be done out of window as per PI discretion.
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Subjects within 1-28 days of documented COVID-19 infection for acute care:
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 to 80 years
- Only a minority of children and adolescents have been described as developing serious illness with COVID-19 infection. As such, this is not an age group at significant risk from complications due to this infection. Adults older than 80 years of age represent a group with the greatest risk of mortality from COVID-19 infection. The presence of significant co-morbidities requiring care that cannot be
- provided at the CC would present a disadvantage to them to have their acute care provided for in the CC.
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- Documentation of positive SARSCoV-19 test by nucleic acid detection (COVID-19 infection , RT-PCR)
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Subjects during recovery phase of the acute illness (day 28 +/- 7 days to 12 weeks) and convalescent phase (Week 13 up to 12 months), Year 2 convalescent phase (13 24 months), Year 3 convalescent phase (25 36 months) after recovery if care has been received at a facility outside of NIH:
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, aged 18 to 80 years.
- Study participants will be invited to continue their participation in the study in years 2 and 3 based on the results of their tests from the first year and their willingness to continue for the two additional years. If test results of imaging, blood, pulmonary function and or bronchoscopy have returned to normal at the end of one year, the need for further cardiopulmonary testing will be assessed for each patient. Anyone who is invited to continue in the 2nd and 3rd years may discontinue their participation at any time.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Pregnancy or lactation Study participants who are enrolled in the study and become pregnant during the enrollment period will be discontinued from further study participation. Exposure to radiation or radiographic contrast agents for research purposes .only would not be warranted for a pregnant woman and her fetus.
- Serious mental illness (e.g. schizophrenia, manic depression) that would limit the ability of the participant to participate willingly into the study.
- -- The conduct of the study requires participation in studies that may be unduly stressful (e.g. MRI, bronchoscopy).
- Severe claustrophobia that would prohibit the conduct of imaging by MRI even if sedation is provided.
- Cardiac pacemaker or implantable defibrillator unless it is safe for MRI
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- Cerebral aneurysm clip unless it is safe for MRI
- Brain stimulator (e.g. TENS-Unit) unless it is safe for MRI
- Any type of ear implant unless it is safe for MRI
- Foreign body in the eye (e.g. metal shavings)
- Metal shrapnel or bullet
- Any implanted device (e.g. insulin pump, drug infusion device
- Patients requiring mechanical ventilation at an outside hospital prior to transfer. Transporting these patients adds risk to their care.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Cardiopulmonary Inflammation and Multi-System Imaging During the Clinical Course of COVID-19 Infection in Asymptomatic and Symptomatic Persons (COVID ARC 19)
Background:
COVID-19 virus infection differs among people. Some people have no or mild symptoms. For others, COVID-19 is life threatening and causes damage to the body s organs. Researchers want to better understand the virus to learn how to kill it.
Read more
Objective:
To understand how the COVID-19 virus causes wide differences in how sick one can become from the infection.
Eligibility:
People ages 18-80 with COVID-19 infection
Design:
Participants will be screened with a review of their medical records.
Participants who enter the study at the beginning of their COVID-19 infection will stay in the hospital until they are healthy enough to go home. Those who enter after they have recovered may need to stay in the hospital 1-2 nights to perform the study tests.
Participants will have MRI and CT scans of the brain, heart, and lungs. They will lie in a machine that takes pictures of the body. For the MRI, soft padding or a coil will be placed around their head and chest. They may receive a dye injected into a vein.
Participants will have an ultrasound of the kidneys and heart.
Participants will provide blood and urine samples. They will provide nasal swabs.
Participants will have a bronchoscopy. A thin tube will be placed through the nose or mouth into the airway. Saltwater will be squirted into the lungs and removed by suction.
Participants may provide a spinal fluid sample. A needle injected into the spinal canal will obtain fluid.
Participants will have lung and heart function tests.
At various points after recovery, participants will repeat many of these tests.
Read the detailed description
Study Description: This protocol will enroll patients within a 50 mile radius of Bethesda, Maryland, to the Clinical Center in a longitudinal study using granular clinical observations including pulmonary and cardiac functional assessments, comprehensive immunologic evaluations, and innovative imaging. Sequential analysis of blood, bronchoalveolar lavage, and spinal fluid, with simultaneous serial imaging can provide insights into mechanisms associated with the initiation, progression and resolution of organ dysfunction and systemic inflammation due to COVID-19 infection.
Objectives:
Primary objective:
To link inflammatory responses present in blood, bronchoalveolar lavage, spinal fluid, and with imaging of COVID-19 target organs (lungs, heart and brain) during the earliest stages of infection and at subsequent time points as the infection and host responses evolve, through recovery.
Secondary objectives
Assess the long-term effects of COVID-19 infection on immunologic, neurologic, cardiac and pulmonary function
Endpoints:
- Measure inflammatory responses present in blood, bronchoalveolar lavage, and spinal fluid during the course of COVID-19 infection
- Obtain imaging of target organs during the course of COVID-19 infection
- Evaluate long-term effects of COVID-19 infection on immunologic, cardiac, pulmonary and neural function
- Conditions
- Acute and Long Term Effects of COVID-19 on Systemic Inflammation, Acute and Long Term Effects of COVID-19 on Lung Function, Acute and Long Term Effects of COVID-19 on Cardiac Function, Acute and Long Term Effects of COVID-19 on Kidney Function, Acute and Long Term Effects of COVID-19 on Brain Function
- Keywords
- Immunological Function, SARSCoV-2, Neurologic Function, Cardiac Function, Pulmonary Function, Natural History
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 |
|---|---|---|
| Acutely illl subjects | COVID-19 subjects treated at the Clinical Center, followed through recovery and into convalescence | |
| Recovered subjects | COVID-19 subjects who were treated at other hospitals, followed through recovery and into convalescence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory responses of cells in lung and circulation
Link inflammatory responses present in blood and bronchoalveolar lavage with imaging of COVID-19 target organs (lungs, heart, brain ) during the earliest stages of infection and at subsequent time points as the infection and host responses evolve, through recovery.
Measured: From onset of illness in hospital through acute phase ( days 1 28 more or less 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start21 May 2020
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute and Long Term Effects of COVID-19 on Systemic InflammationStudies of the same condition, open and under way.
- 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
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Anthony F Suffredini, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04401449
- Sponsor's protocol ID
- 200113
- Other IDs
- 20-CC-0113
- Status last verified
- 13 Oct 2026
- First submitted
- 22 May 2020
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The protocol is silent about Individual Participant Data (IPD) sharing.
Publications
Mao L, Jin H, Wang M, Hu Y, Chen S, He Q, Chang J, Hong C, Zhou Y, Wang D, Miao X, Li Y, Hu B. Neurologic Manifestations of Hospitalized Patients With Coronavirus Disease 2019 in Wuhan, China. JAMA Neurol. 2020 Jun 1;77(6):683-690. doi: 10.1001/jamaneurol.2020.1127.
PubMed 32275288Driggin E, Madhavan MV, Bikdeli B, Chuich T, Laracy J, Biondi-Zoccai G, Brown TS, Der Nigoghossian C, Zidar DA, Haythe J, Brodie D, Beckman JA, Kirtane AJ, Stone GW, Krumholz HM, Parikh SA. Cardiovascular Considerations for Patients, Health Care Workers, and Health Systems During the COVID-19 Pandemic. J Am Coll Cardiol. 2020 May 12;75(18):2352-2371. doi: 10.1016/j.jacc.2020.03.031. Epub 2020 Mar 19.
PubMed 32201335Campbell-Washburn AE, Kanth S, Thurston MD, Mancini C, O'Brien KJ, Potersnak A, Wang H, Huapaya J, Regenold D, Baute S, Javed A, Suffredini AF. A longitudinal study of quantitative pulmonary dynamic contrast enhanced MRI following COVID-19 infection. Respir Res. 2026 Mar 26;27(1):221. doi: 10.1186/s12931-026-03582-w.
PubMed 41888852Huapaya JA, Higgins J, Kanth S, Demirkale CY, Gairhe S, Aboye EA, Regenold D, Sahagun SJ, Pastor G, Swaim D, Dewar R, Rehman T, Highbarger HC, Lallemand P, Laverdure S, Adelsberger J, Rupert A, Li W, Krack J, Teferi G, Kuruppu J, Strich JR, Davey R, Childs R, Chertow D, Kovacs JA, Barnett C, Torabi-Parizi P, Suffredini AF; COVID-ARC Study Group. Vaccination Ameliorates Cellular Inflammatory Responses in SARS-CoV-2 Breakthrough Infections. J Infect Dis. 2023 Jun 28;228(1):46-58. doi: 10.1093/infdis/jiad045.
PubMed 36801946
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiopulmonary Inflammation and Multi-System Imaging During the Clinical Course of COVID-19 Infection in Asymptomatic and Symptomatic Persons (COVID ARC 19)
- ClinicalTrials.gov ID
- NCT04401449
- Acronym / sponsor ID
- 200113
- Conditions
- Acute and Long Term Effects of COVID-19 on Systemic Inflammation, Acute and Long Term Effects of COVID-19 on Lung Function, Acute and Long Term Effects of COVID-19 on Cardiac Function, Acute and Long Term Effects of COVID-19 on Kidney Function, Acute and Long Term Effects of COVID-19 on Brain Function
- Keywords
- Immunological Function, SARSCoV-2, Neurologic Function, Cardiac Function, Pulmonary Function, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 21 May 2020 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 26 May 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:
COVID-19 virus infection differs among people. Some people have no or mild symptoms. For others, COVID-19 is life threatening and causes damage to the body s organs. Researchers want to better understand the virus to learn how to kill it.
Objective:
To understand how the COVID-19 virus causes wide differences in how sick one can become from the infection.
Eligibility:
People ages 18-80 with COVID-19 infection
Design:
Participants will be screened with a review of their medical records.
Participants who enter the study at the beginning of their COVID-19 infection will stay in the hospital until they are healthy enough to go home. Those who enter after they have recovered may need to stay in the hospital 1-2 nights to perform the study tests.
Participants will have MRI and CT scans of the brain, heart, and lungs. They will lie in a machine that takes pictures of the body. For the MRI, soft padding or a coil will be placed around their head and chest. They may receive a dye injected into a vein.
Participants will have an ultrasound of the kidneys and heart.
Participants will provide blood and urine samples. They will provide nasal swabs.
Participants will have a bronchoscopy. A thin tube will be placed through the nose or mouth into the airway. Saltwater will be squirted into the lungs and removed by suction.
Participants may provide a spinal fluid sample. A needle injected into the spinal canal will obtain fluid.
Participants will have lung and heart function tests.
At various points after recovery, participants will repeat many of these tests.
Detailed description
Study Description: This protocol will enroll patients within a 50 mile radius of Bethesda, Maryland, to the Clinical Center in a longitudinal study using granular clinical observations including pulmonary and cardiac functional assessments, comprehensive immunologic evaluations, and innovative imaging. Sequential analysis of blood, bronchoalveolar lavage, and spinal fluid, with simultaneous serial imaging can provide insights into mechanisms associated with the initiation, progression and resolution of organ dysfunction and systemic inflammation due to COVID-19 infection.
Objectives:
Primary objective:
To link inflammatory responses present in blood, bronchoalveolar lavage, spinal fluid, and with imaging of COVID-19 target organs (lungs, heart and brain) during the earliest stages of infection and at subsequent time points as the infection and host responses evolve, through recovery.
Secondary objectives
Assess the long-term effects of COVID-19 infection on immunologic, neurologic, cardiac and pulmonary function
Endpoints:
- Measure inflammatory responses present in blood, bronchoalveolar lavage, and spinal fluid during the course of COVID-19 infection
- Obtain imaging of target organs during the course of COVID-19 infection
- Evaluate long-term effects of COVID-19 infection on immunologic, cardiac, pulmonary and neural function
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acutely illl subjects | – | –COVID-19 subjects treated at the Clinical Center, followed through recovery and into convalescence |
| Recovered subjects | – | –COVID-19 subjects who were treated at other hospitals, followed through recovery and into convalescence |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- men or women, 18 - 80 years of age, a) within 1- 28 days (+/- 7 days) of documented COVID-19 infection for acute care (n=150) with subsequent follow-up during recovery (28 +/- 7 days to 12 weeks) and then during convalescence (Week 13 to 12 months - year 1), year 2 convalesecent phase and year 3 convalesecent phase. Each Phase visit can be done out of window as per PI discretion. OR b) if care for acute COVID-19 infections was given at an outside site, participants would be evaluated during recovery (28 +/- 7 days to 12 weeks, during convalescence (Week 13 to 12 months - year 1), year 2 - convalesecent phase and year 3 - convalesecent phase) Each Phase visit can be done out of window as per PI discretion.
Key inclusion criteria (12 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 to 80 years
- provided at the CC would present a disadvantage to them to have their acute care provided for in the CC.
- Documentation of positive SARSCoV-19 test by nucleic acid detection (COVID-19 infection , RT-PCR)
Key exclusion criteria (13 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Pregnancy or lactation Study participants who are enrolled in the study and become pregnant during the enrollment period will be discontinued from further study participation. Exposure to radiation or radiographic contrast agents for research purposes .only would not be warranted for a pregnant woman and her fetus.
- Serious mental illness (e.g. schizophrenia, manic depression) that would limit the ability of the participant to participate willingly into the study.
- -- The conduct of the study requires participation in studies that may be unduly stressful (e.g. MRI, bronchoscopy).
- Severe claustrophobia that would prohibit the conduct of imaging by MRI even if sedation is provided.
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
Inflammatory responses of cells in lung and circulation
Time frame: From onset of illness in hospital through acute phase ( days 1 28 more or less 7
Link inflammatory responses present in blood and bronchoalveolar lavage with imaging of COVID-19 target organs (lungs, heart, brain ) during the earliest stages of infection and at subsequent time points as the infection and host responses evolve, through recovery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Background: PubMed 32275288Mao L, Jin H, Wang M, Hu Y, Chen S, He Q, Chang J, Hong C, Zhou Y, Wang D, Miao X, Li Y, Hu B. Neurologic Manifestations of Hospitalized Patients With Coronavirus Disease 2019 in Wuhan, China. JAMA Neurol. 2020 Jun 1;77(6):683-690. doi: 10.1001/jamaneurol.2020.1127.
- Background: PubMed 32201335Driggin E, Madhavan MV, Bikdeli B, Chuich T, Laracy J, Biondi-Zoccai G, Brown TS, Der Nigoghossian C, Zidar DA, Haythe J, Brodie D, Beckman JA, Kirtane AJ, Stone GW, Krumholz HM, Parikh SA. Cardiovascular Considerations for Patients, Health Care Workers, and Health Systems During the COVID-19 Pandemic. J Am Coll Cardiol. 2020 May 12;75(18):2352-2371. doi: 10.1016/j.jacc.2020.03.031. Epub 2020 Mar 19.
- Derived from this study: PubMed 41888852Campbell-Washburn AE, Kanth S, Thurston MD, Mancini C, O'Brien KJ, Potersnak A, Wang H, Huapaya J, Regenold D, Baute S, Javed A, Suffredini AF. A longitudinal study of quantitative pulmonary dynamic contrast enhanced MRI following COVID-19 infection. Respir Res. 2026 Mar 26;27(1):221. doi: 10.1186/s12931-026-03582-w.
- Derived from this study: PubMed 36801946Huapaya JA, Higgins J, Kanth S, Demirkale CY, Gairhe S, Aboye EA, Regenold D, Sahagun SJ, Pastor G, Swaim D, Dewar R, Rehman T, Highbarger HC, Lallemand P, Laverdure S, Adelsberger J, Rupert A, Li W, Krack J, Teferi G, Kuruppu J, Strich JR, Davey R, Childs R, Chertow D, Kovacs JA, Barnett C, Torabi-Parizi P, Suffredini AF; COVID-ARC Study Group. Vaccination Ameliorates Cellular Inflammatory Responses in SARS-CoV-2 Breakthrough Infections. J Infect Dis. 2023 Jun 28;228(1):46-58. doi: 10.1093/infdis/jiad045.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. The protocol is silent about Individual Participant Data (IPD) sharing.
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. This study is not recruiting at the moment.
Anthony F Suffredini, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute and Long Term Effects of COVID-19 on Systemic Inflammation and Acute and Long Term Effects of COVID-19 on Lung Function, run by National Institutes of Health Clinical Center (CC) at 2 sites 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 12 inclusion and 13 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: finished, as of the sponsor's last update on 15 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 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory responses of cells in lung and circulation (time frame: From onset of illness in hospital through acute phase ( days 1 28 more or less 7). 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 NCT04401449, which also lists 4 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 15 Oct 2026.