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Completed

NCT Number: NCT04958889

COVID-19 Recovery Study: 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.

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Key information

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV2) COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes HIV Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

No intervention

Other

(observational study)

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

Secondary outcomes

  1. Change in mMRC rates of dyspnea

    Time frame: 1 and 4 months

    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.

  2. Change in cognitive function (learning and memory) as measured by the RAVLT from month 1 to month 4

    Time frame: 1 and 4 months

    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.

  3. 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

    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.

  4. 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

    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.

  5. 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

    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.

  6. Dysautonomia measured through orthostatic hypotension and orthostatic tachycardia

    Time frame: 1 month

    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).

  7. Dysautonomia measured through orthostatic hypotension and orthostatic tachycardia

    Time frame: 4 months

    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).

  8. Change in PHQ-9 depression symptoms

    Time frame: 1 and 4 months

    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.

  9. Change in quality of life as assessed using the Short Form-36

    Time frame: 1 and 4 months

    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).

  10. Change in insomnia as assessed using the Insomnia Severity Index from month 1 to month 4

    Time frame: 1 and 4 months

    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.

  11. Change in anxiety as assessed using the GAD-7 from month 1 to month 4

    Time frame: 1 and 4 months

    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.

  12. Change in overall mental health as assessed using the CAT-MH from month 1 to month 4

    Time frame: 1 and 4 months

    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.

Other outcomes

  1. New self-reported diagnoses over 12 months after COVID-19 infection

    Time frame: 1, 2, 4, 6 and 12 months

    New medical diagnoses after COVID-19 infection.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Rush University Medical Center
  • University of California, San Francisco
  • amfAR, The Foundation for AIDS Research

Registry information

Official study title

Symptoms and Biomarkers of Long COVID-19 in People Living With and Without HIV

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 12, 2021
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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