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

NCT04958889 | Completed

• 1 other identifier: IRB00278774
• Study Type: observational
• Target: 392
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV2); HIV

Keywords

COVID-19; Long COVID; HIV

Outcome Measures

Primary Outcomes (3)

• 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).

  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).

  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).

  1, 2, 4, 6 and 12 months

Secondary Outcomes (12)

• Change in mMRC rates of dyspnea

  1 and 4 months

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

  1 and 4 months

• Change in cognitive function (attention and executive function) as assessed through oral trail tests from month 1 to month 4

  1 and 4 months

• Change in cognitive function (attention and working memory) as assessed through digit span tests from month 1 to month 4

  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

  1 and 4 months

Other Outcomes (1)

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

  1, 2, 4, 6 and 12 months

Study Arms (4)

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

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

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.

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.

Other: No intervention

Interventions

No intervention OTHER

(observational study)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Rush University Medical Center: collaborator
• University of California, San Francisco: collaborator
• amfAR, The Foundation for AIDS Research: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

A mobile phlebotomist will draw blood at the participant's home at their convenience. The mobile phlebotomist will overnight ship blood samples using International Air Transport Association (IATA) approved procedures to the Immunology Specialty Lab at Rush University for processing, clinical laboratory testing, and storage. Work with samples will occur at Rush, Johns Hopkins and University of California, San Francisco (UCSF).

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Annie Antar, MD,PhD

  Infectious Disease - Broadway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 12, 2021
• Study Start: June 11, 2021
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)