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

NCT ID: NCT04958889

Last Updated: 2024-04-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 392 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-11
• Study Completion Date: 2024-03-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No intervention

Intervention Type: OTHER

(observational study)

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

No intervention

Intervention Type: OTHER

(observational study)

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.

No intervention

Intervention Type: OTHER

(observational study)

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.

No intervention

Intervention Type: OTHER

(observational study)

Interventions

No intervention

(observational study)

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rush University Medical Center

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: collaborator

amfAR, The Foundation for AIDS Research

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Annie Antar, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Infectious Disease - Broadway

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00278774

Identifier Type: -

Identifier Source: org_study_id