Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV2)NCT04958889
COVID-19 Recovery Study: Symptoms and Biomarkers of Long COVID-19 in People Living With and Without HIV
An observational study of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV2) and HIV, run by Johns Hopkins University at 1 site in United States.
Trial summary
This observational study will prospectively characterize the long-term symptoms and side effects of COVID-19 in cohorts of people living with and without HIV. This will be achieved through a series of remote study visits involving completing surveys about health history, symptoms, mood, quality of life and changes in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV2), HIV
- How many people
- 392 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2021to 31 Mar 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Investigators will recruit volunteers with and without HIV and with and without a COVID-19 diagnosis from across the contiguous 48 US states in the following numbers: 1. 110 adult people living with HIV (PWH) with COVID-19 symptom onset or first positive test within the prior 4 weeks 2. 110 adult HIV-negative people with COVID-19 symptom onset or first positive test within the prior 4 weeks 3. 45 adult PWH with no history of COVID-19 4. 50 adult HIV-negative people with no history of COVID-19 Investigators aim to enroll a population of PWH that is roughly representative of the demographic and geographic diversity of PWH across the United States.
Who may be able to join
- Adults 18 years of age or older
- Living within the contiguous 48 states
- Groups 1 and 3: self-reported HIV infection
- Groups 2 and 4: self-reported HIV negative
Who cannot join
- Inability to communicate by telephone in English or Spanish
- Inability to complete required study events
- A first or only diagnosis of COVID-19 5 or more weeks prior to first contact with participant
- Groups 3 and 4: diagnosis of cOVID-19 ever, or participant suspects they had COVID-19 at any time regardless of whether they were tested
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Symptoms and Biomarkers of Long COVID-19 in People Living With and Without HIV
This observational study will prospectively characterize the long-term symptoms and side effects of COVID-19 in cohorts of people living with and without HIV. This will be achieved through a series of remote study visits involving completing surveys about health history, symptoms, mood, quality of life and changes in health, and up to two blood draws from home through the use of a mobile phlebotomy service.
Read the detailed description
This is a prospective observational study being conducted to learn about late (2+ weeks or more) effects of COVID-19 in people living with and without HIV. The investigators plan to do this by studying people who have COVID-19 and people who have not had COVID-19, and by studying people living with HIV and people who are HIV-negative. The investigators will investigate the average duration of symptoms after COVID-19, how these symptoms affect quality of life, and what medical complications are common after COVID-19 in people with and without HIV.
Participation involves:
- Participant completion of surveys about themselves, their health history, their quality of life and mood in the recent past, and about COVID-19 or HIV if the participant has a history of either infection. The investigators will ask participants to answer questions in up to 5 follow-up surveys over the course of a year about their symptoms, mood, quality of life, and changes in health. Participants will also complete a series of short tests of thinking, memory, and reaction speed at certain follow-up surveys.
- Up to two visits to the participant's home (or an acceptable location of their choosing) by a phlebotomist. The phlebotomist will collect about 3.5 tablespoons of blood, as well as measure height, weight, and vital signs when laying down and standing up.
This is a fully remote study and all study activities can be done from home or another location of the participant's choosing.
- Being tested
- No intervention
- Keywords
- COVID-19, Long COVID, HIV
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
(observational study)
| Study group | Role | What they receive |
|---|---|---|
| HIV+ adults with recent COVID-19 diagnosis | Required study visits:
* Baseline questionnaire at enrollment or month 1.
* Follow up questionnaire at month 1 and month 4
* Height, weight, vital signs, and blood sampling at month 1 and month 4
Optional study visits:
• Follow up questionnaire at month 2, month 6, and month 12 Receives: Other: No intervention | |
| HIV- adults with recent COVID-19 diagnosis | Required study visits:
* Baseline questionnaire at enrollment or month 1.
* Follow up questionnaire at month 1 and month 4
* Height, weight, vital signs, and blood sampling at month 1 and month 4
Optional study visits:
• Follow up questionnaire at month 2, month 6, and month 12 Receives: Other: No intervention | |
| HIV+ adults with no history of COVID-19 | Required study visits:
* Baseline questionnaire at enrollment.
* Follow up questionnaire at enrollment and approximately 3 months after first follow up questionnaire.
* Height, weight, vital signs, and blood sampling at enrollment.
Optional study visits:
• Follow up questionnaire at 1, 5, and 11 months after first follow up questionnaire. Receives: Other: No intervention | |
| HIV- adults with no history of COVID-19 | Required study visits:
* Baseline questionnaire at enrollment.
* Follow up questionnaire at enrollment and approximately 3 months after first follow up questionnaire.
Optional study visits:
• Follow up questionnaire at 1, 5, and 11 months after first follow up questionnaire. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in symptom severity after COVID-19 infection over 12 months after infection
Time to return to usual health and activities, as measured using the Influenza Patient-reported Outcome (Flu-PRO) instrument. The overall score is calculated as the mean across 32 items, and ranges from 0 (symptom free) to 4 (very severe symptoms).
Measured: 1, 2, 4, 6 and 12 months
Change in fatigue severity
Presence/absence of fatigue post-symptom onset, severity of fatigue and its effect on activity level as measured using the Fatigue Severity Scale. The Fatigue Severity Scale is a 9-item tool and each item is ranked from 1 (strongly disagree) to 7 (strongly agree). The item scores are added to generate the overall score, ranging from 9 (least severe) to 63 (most severe).
Measured: 1 and 4 months
Change in number of COVID-19 symptoms experienced over 12 months after infection
Number of symptoms experienced using Flu-PRO and additional COVID-19 specific symptoms in domains of neuropsychiatry, cardiovascular, and skin. Flu-PRO scores range from 0 (symptom free) to 4 (very severe symptoms).
Measured: 1, 2, 4, 6 and 12 months
Secondary outcomes (12)
Change in mMRC rates of dyspnea
The Modified Medical Research Council (mMRC) instrument will be used to measure dyspnea. The mMRC rates severity of dyspnea on a scale of 0 to 4, 4 indicating the highest level of dyspnea severity.
Measured: 1 and 4 months
Change in cognitive function (learning and memory) as measured by the RAVLT from month 1 to month 4
Learning and memory assessed through the Rey Auditory Verbal Learning Test (RAVLT), in which participants receive a total learning score (range 0-36), a delayed recall score (range 0-12) and a recognition score (range -12 - +12). In all cases, a higher score indicates better recall.
Measured: 1 and 4 months
Change in cognitive function (attention and executive function) as assessed through oral trail tests from month 1 to month 4
Attention and executive function assessed through an oral trail test, in which participants are timed between 0 and 300 seconds. A higher time indicates lower attention and executive function.
Measured: 1 and 4 months
Change in cognitive function (attention and working memory) as assessed through digit span tests from month 1 to month 4
Attention and working memory assessed through a digit span task-forward and backward test. The forward test is scored from 0-16 and the backward test from 0-18, higher scores indicating better attention and memory.
Measured: 1 and 4 months
Change in cognitive function (phonemic and semantic fluency) as assessed through letter and category-guided fluency tests from month 1 to month 4
Phonemic and semantic fluency assessed through a letter-guided and category-guided fluency test. Scores range from 0-100, with a higher score indicating increased fluency.
Measured: 1 and 4 months
Dysautonomia measured through orthostatic hypotension and orthostatic tachycardia
Orthostatic hypotension and orthostatic tachycardia (decrease in systolic blood pressure of 20 mmHg or decrease in diastolic blood pressure of 10 mmHg after 3 minutes of standing compared to sitting).
Measured: 1 month
Dysautonomia measured through orthostatic hypotension and orthostatic tachycardia
Orthostatic hypotension and orthostatic tachycardia (decrease in systolic blood pressure of 20 mmHg or decrease in diastolic blood pressure of 10 mmHg after 3 minutes of standing compared to sitting).
Measured: 4 months
Change in PHQ-9 depression symptoms
Self-reported measure of depressive symptoms using The Patient Health Questionnaire (PHQ-9). The PHQ-9 is a 9 item scale with a score range of 1-27 with higher scores indicating severe depression.
Measured: 1 and 4 months
Change in quality of life as assessed using the Short Form-36
Quality of life in the domains of vitality, physical functioning, bodily pain, general health perceptions, physical and emotional and social role functioning, as assessed using the Short Form-36. The Short Form-36 measures physical and mental health using 8 scales. The final score ranges from 0 (worse health status) to 100 (better health status).
Measured: 1 and 4 months
Change in insomnia as assessed using the Insomnia Severity Index from month 1 to month 4
Presence, severity, and patterns of insomnia, and its interference with daily functioning as assessed by the Insomnia Severity Index. The Insomnia Severity Index is a 7 item scale with a score range of 0-28. A higher score indicates severe insomnia.
Measured: 1 and 4 months
Change in anxiety as assessed using the GAD-7 from month 1 to month 4
Self-reported measure of anxiety using The Generalized Anxiety Disorder (GAD-7). The GAD-7 is a 7 item instrument used to measure or assess anxiety disorders. The score range is from 0-21. A higher score indicates severe anxiety.
Measured: 1 and 4 months
Change in overall mental health as assessed using the CAT-MH from month 1 to month 4
Self-reported measures of mental health symptoms (anxiety and depression) using the Computer Adaptive Test-Mental Health (CAT-MH). Scores range from 0-100, with a higher score indicating more severe symptoms.
Measured: 1 and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start11 Jun 2021
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV2)Studies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Rush University Medical Center, University of California, San Francisco, amfAR, The Foundation for AIDS Research
- Responsible party
- Sponsor
- Investigators
- Annie Antar, MD,PhD, Principal investigator, Infectious Disease - Broadway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04958889
- Sponsor's protocol ID
- IRB00278774
- Status last verified
- Apr 2024
- First submitted
- 6 Jul 2021
- Last updated
- 4 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptoms and Biomarkers of Long COVID-19 in People Living With and Without HIV
- ClinicalTrials.gov ID
- NCT04958889
- Acronym / sponsor ID
- IRB00278774
- Keywords
- COVID-19, Long COVID, HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Rush University Medical Center, University of California, San Francisco, amfAR, The Foundation for AIDS Research
- Study start
- 11 Jun 2021 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 12 Jul 2021 (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.
This observational study will prospectively characterize the long-term symptoms and side effects of COVID-19 in cohorts of people living with and without HIV. This will be achieved through a series of remote study visits involving completing surveys about health history, symptoms, mood, quality of life and changes in health, and up to two blood draws from home through the use of a mobile phlebotomy service.
Detailed description
This is a prospective observational study being conducted to learn about late (2+ weeks or more) effects of COVID-19 in people living with and without HIV. The investigators plan to do this by studying people who have COVID-19 and people who have not had COVID-19, and by studying people living with HIV and people who are HIV-negative. The investigators will investigate the average duration of symptoms after COVID-19, how these symptoms affect quality of life, and what medical complications are common after COVID-19 in people with and without HIV.
Participation involves:
- Participant completion of surveys about themselves, their health history, their quality of life and mood in the recent past, and about COVID-19 or HIV if the participant has a history of either infection. The investigators will ask participants to answer questions in up to 5 follow-up surveys over the course of a year about their symptoms, mood, quality of life, and changes in health. Participants will also complete a series of short tests of thinking, memory, and reaction speed at certain follow-up surveys.
- Up to two visits to the participant's home (or an acceptable location of their choosing) by a phlebotomist. The phlebotomist will collect about 3.5 tablespoons of blood, as well as measure height, weight, and vital signs when laying down and standing up.
This is a fully remote study and all study activities can be done from home or another location of the participant's choosing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HIV+ adults with recent COVID-19 diagnosis | – | Other: No interventionRequired study visits: * Baseline questionnaire at enrollment or month 1. * Follow up questionnaire at month 1 and month 4 * Height, weight, vital signs, and blood sampling at month 1 and month 4 Optional study visits: • Follow up questionnaire at month 2, month 6, and month 12 |
| HIV- adults with recent COVID-19 diagnosis | – | Other: No interventionRequired study visits: * Baseline questionnaire at enrollment or month 1. * Follow up questionnaire at month 1 and month 4 * Height, weight, vital signs, and blood sampling at month 1 and month 4 Optional study visits: • Follow up questionnaire at month 2, month 6, and month 12 |
| HIV+ adults with no history of COVID-19 | – | Other: No interventionRequired study visits: * Baseline questionnaire at enrollment. * Follow up questionnaire at enrollment and approximately 3 months after first follow up questionnaire. * Height, weight, vital signs, and blood sampling at enrollment. Optional study visits: • Follow up questionnaire at 1, 5, and 11 months after first follow up questionnaire. |
| HIV- adults with no history of COVID-19 | – | Other: No interventionRequired study visits: * Baseline questionnaire at enrollment. * Follow up questionnaire at enrollment and approximately 3 months after first follow up questionnaire. Optional study visits: • Follow up questionnaire at 1, 5, and 11 months after first follow up questionnaire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Investigators will recruit volunteers with and without HIV and with and without a COVID-19 diagnosis from across the contiguous 48 US states in the following numbers: 1. 110 adult people living with HIV (PWH) with COVID-19 symptom onset or first positive test within the prior 4 weeks 2. 110 adult HIV-negative people with COVID-19 symptom onset or first positive test within the prior 4 weeks 3. 45 adult PWH with no history of COVID-19 4. 50 adult HIV-negative people with no history of COVID-19 Investigators aim to enroll a population of PWH that is roughly representative of the demographic and geographic diversity of PWH across the United States.
Key inclusion criteria (4 listed)
- Adults 18 years of age or older
- Living within the contiguous 48 states
- Groups 1 and 3: self-reported HIV infection
- Groups 2 and 4: self-reported HIV negative
Key exclusion criteria (4 listed)
- Inability to communicate by telephone in English or Spanish
- Inability to complete required study events
- A first or only diagnosis of COVID-19 5 or more weeks prior to first contact with participant
- Groups 3 and 4: diagnosis of cOVID-19 ever, or participant suspects they had COVID-19 at any time regardless of whether they were tested
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention(observational study) | Other | HIV+ adults with no history of COVID-19, HIV+ adults with recent COVID-19 diagnosis, HIV- adults with no history of COVID-19, HIV- adults with recent COVID-19 diagnosis |
Primary outcome
Change in symptom severity after COVID-19 infection over 12 months after infection
Time frame: 1, 2, 4, 6 and 12 months
Time to return to usual health and activities, as measured using the Influenza Patient-reported Outcome (Flu-PRO) instrument. The overall score is calculated as the mean across 32 items, and ranges from 0 (symptom free) to 4 (very severe symptoms).
Change in fatigue severity
Time frame: 1 and 4 months
Presence/absence of fatigue post-symptom onset, severity of fatigue and its effect on activity level as measured using the Fatigue Severity Scale. The Fatigue Severity Scale is a 9-item tool and each item is ranked from 1 (strongly disagree) to 7 (strongly agree). The item scores are added to generate the overall score, ranging from 9 (least severe) to 63 (most severe).
Change in number of COVID-19 symptoms experienced over 12 months after infection
Time frame: 1, 2, 4, 6 and 12 months
Number of symptoms experienced using Flu-PRO and additional COVID-19 specific symptoms in domains of neuropsychiatry, cardiovascular, and skin. Flu-PRO scores range from 0 (symptom free) to 4 (very severe symptoms).
12 secondary outcomes
Change in mMRC rates of dyspnea
Time frame: 1 and 4 months
Change in cognitive function (learning and memory) as measured by the RAVLT from month 1 to month 4
Time frame: 1 and 4 months
Change in cognitive function (attention and executive function) as assessed through oral trail tests from month 1 to month 4
Time frame: 1 and 4 months
Change in cognitive function (attention and working memory) as assessed through digit span tests from month 1 to month 4
Time frame: 1 and 4 months
Change in cognitive function (phonemic and semantic fluency) as assessed through letter and category-guided fluency tests from month 1 to month 4
Time frame: 1 and 4 months
Dysautonomia measured through orthostatic hypotension and orthostatic tachycardia
Time frame: 1 month
Dysautonomia measured through orthostatic hypotension and orthostatic tachycardia
Time frame: 4 months
Change in PHQ-9 depression symptoms
Time frame: 1 and 4 months
Change in quality of life as assessed using the Short Form-36
Time frame: 1 and 4 months
Change in insomnia as assessed using the Insomnia Severity Index from month 1 to month 4
Time frame: 1 and 4 months
Change in anxiety as assessed using the GAD-7 from month 1 to month 4
Time frame: 1 and 4 months
Change in overall mental health as assessed using the CAT-MH from month 1 to month 4
Time frame: 1 and 4 months
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 4 Apr 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Annie Antar, MD,PhD principal investigator
Infectious Disease - Broadway
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 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV2) and HIV, run by Johns Hopkins University 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 4 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: finished, as of the sponsor's last update on 4 Apr 2024. 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?
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?
Change in symptom severity after COVID-19 infection over 12 months after infection (time frame: 1, 2, 4, 6 and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2024.