NCT04333953

Brief Summary

Currently, limited data is available about patients with HIV in the context of the COVID-19 pandemic. People with HIV who have not achieved viral suppression through antiretroviral treatment may have a compromised immune system that leaves them vulnerable to infections and disease progression. However, little is known about the presentation and clinical outcomes of patients with HIV and SARS-CoV-2. Our aim is to characterize the clinical presentation and disease course of COVID-19 in patients with HIV.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
412

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2022

Completed
Last Updated

May 23, 2022

Status Verified

May 1, 2022

Enrollment Period

3 months

First QC Date

March 31, 2020

Last Update Submit

May 16, 2022

Conditions

Keywords

HIVAIDSCOVID-19SARS-CoV-2clinical presentationprogressionclinical outcome

Outcome Measures

Primary Outcomes (1)

  • Mortality

    COVID-19 related death among patients with HIV and COVID-19

    30 days

Secondary Outcomes (5)

  • Frequency of patients requiring hospital admissions

    30 days

  • Frequency of patients requiring ICU admissions

    30 days

  • Frequency of respiratory support use

    30 days

  • Frequency of kidney injury

    30 days

  • Frequency of liver injury

    30 days

Interventions

No intervention, observational study

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with HIV disease who are diagnosed with COVID-19, inpatient or outpatient

You may qualify if:

  • HIV disease
  • Laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri-Columbia

Columbia, Missouri, 65212, United States

Location

Related Publications (1)

  • Dandachi D, Geiger G, Montgomery MW, Karmen-Tuohy S, Golzy M, Antar AAR, Llibre JM, Camazine M, Diaz-De Santiago A, Carlucci PM, Zacharioudakis IM, Rahimian J, Wanjalla CN, Slim J, Arinze F, Kratz AMP, Jones JL, Patel SM, Kitchell E, Francis A, Ray M, Koren DE, Baddley JW, Hill B, Sax PE, Chow J. Characteristics, Comorbidities, and Outcomes in a Multicenter Registry of Patients With Human Immunodeficiency Virus and Coronavirus Disease 2019. Clin Infect Dis. 2021 Oct 5;73(7):e1964-e1972. doi: 10.1093/cid/ciaa1339.

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeCOVID-19Disease Progression

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsLung DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Clinical Medicine

Study Record Dates

First Submitted

March 31, 2020

First Posted

April 3, 2020

Study Start

April 1, 2020

Primary Completion

July 1, 2020

Study Completion

March 28, 2022

Last Updated

May 23, 2022

Record last verified: 2022-05

Locations