Clinical trial NCT04958889: COVID-19 Recovery Study: Symptoms and Biomarkers of Long COVID-19 in People Living With and Without HIV
Official title: Symptoms and Biomarkers of Long COVID-19 in People Living With and Without HIV
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV2)
HIV
Keywords: COVID-19
Long COVID
HIV
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Rush University Medical Center
name: University of California, San Francisco
name: amfAR, The Foundation for AIDS Research
First posted: 2021-07-12
Enrollment: 392
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in symptom severity after COVID-19 infection over 12 months after infection
timeFrame: 1, 2, 4, 6 and 12 months
measure: Change in fatigue severity
timeFrame: 1 and 4 months
measure: Change in number of COVID-19 symptoms experienced over 12 months after infection
timeFrame: 1, 2, 4, 6 and 12 months
Secondary outcomes:
measure: Change in mMRC rates of dyspnea
timeFrame: 1 and 4 months
measure: Change in cognitive function (learning and memory) as measured by the RAVLT from month 1 to month 4
timeFrame: 1 and 4 months
measure: Change in cognitive function (attention and executive function) as assessed through oral trail tests from month 1 to month 4
timeFrame: 1 and 4 months
measure: Change in cognitive function (attention and working memory) as assessed through digit span tests from month 1 to month 4
timeFrame: 1 and 4 months
measure: Change in cognitive function (phonemic and semantic fluency) as assessed through letter and category-guided fluency tests from month 1 to month 4
timeFrame: 1 and 4 months
measure: Dysautonomia measured through orthostatic hypotension and orthostatic tachycardia
timeFrame: 1 month
measure: Dysautonomia measured through orthostatic hypotension and orthostatic tachycardia
timeFrame: 4 months
measure: Change in PHQ-9 depression symptoms
timeFrame: 1 and 4 months
measure: Change in quality of life as assessed using the Short Form-36
timeFrame: 1 and 4 months
measure: Change in insomnia as assessed using the Insomnia Severity Index from month 1 to month 4
timeFrame: 1 and 4 months
measure: Change in anxiety as assessed using the GAD-7 from month 1 to month 4
timeFrame: 1 and 4 months
measure: Change in overall mental health as assessed using the CAT-MH from month 1 to month 4
timeFrame: 1 and 4 months
Other outcomes:
measure: New self-reported diagnoses over 12 months after COVID-19 infection
timeFrame: 1, 2, 4, 6 and 12 months
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Infectious Disease - Broadway
name: Annie Antar, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: