History of Changes for Study: NCT04333953

COVID-19 in Patients With HIV

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Study Record Versions

Version	Submitted Date	Changes
1	April 1, 2020	None (earliest Version on record)
2	April 4, 2020	References and Study Status
3	April 19, 2021	Study Status and Study Identification
4	May 16, 2022	Recruitment Status, Study Status, Contacts/Locations, Study Design and References

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	262095
Brief Title:	COVID-19 in Patients With HIV
Official Title:	Prospective Observational Study for Patients With HIV and Confirmed SARS-CoV-2
Secondary IDs:

Study Status


Record Verification:	April 2020
Overall Status:	Recruiting
Study Start:	April 1, 2020
Primary Completion:	October 1, 2020 [Anticipated]
Study Completion:	October 1, 2020 [Anticipated]

First Submitted:	March 31, 2020
First Submitted that Met QC Criteria:	April 1, 2020
First Posted:	April 3, 2020 [Actual]

Last Update Submitted that Met QC Criteria:	April 1, 2020
Last Update Posted:	April 3, 2020 [Actual]

Sponsor/Collaborators


Sponsor:	University of Missouri-Columbia
Responsible Party:	Principal Investigator Investigator: Dima Dandachi Official Title: Assistant Professor of Clinical Medicine Affiliation: University of Missouri-Columbia
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	No

Study Description

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.

Detailed Description:

Currently, limited data is available about patients with HIV in the context of the COVID-19 pandemic. People with HIV (PWH)/AIDS, or people with HIV who have not achieved viral suppression through antiretroviral treatment may have at higher risk for SARS-CoV-2 infections and disease progression. At present there is no evidence to suggest that there is an increased risk of infection and increased severity of illness for PWH. We know that during the SARS and MERS outbreaks, there were only few case reports of mild disease among PWH. Current clinical data suggest the main mortality risk factors are linked to older age and other co-morbidities. However, some healthy people have also developed severe disease from the SARS-CoV-2 infection.

This is a multi-center prospective observational study. Our aim is to characterize the clinical presentation and clinical course of COVID-19 in patients with HIV.

Patients with HIV and confirmed SARS-Cov-2 will be identified during routine clinical care in the inpatient or outpatient setting.

Contributors will share de-identified demographic data, health history data, and clinical data pertaining the patient's presentation with COVID-19 and outcomes obtained during routine care for their patients, using the secure online data collection tool REDCap.

Conditions


Conditions:	HIV/AIDS COVID-19 SARS-CoV-2
Keywords:	HIV AIDS COVID-19 SARS-CoV-2 clinical presentation progression clinical outcome

Study Design


Study Type:	Observational [Patient Registry]
Observational Study Model:	Case-Only
Time Perspective:	Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment:	500 [Anticipated]
Number of Groups/Cohorts	0
Target Follow-Up Duration:	1 Month

Groups and Interventions


Intervention Details:
	No intervention No intervention, observational study

Outcome Measures


Primary Outcome Measures:
1.	Mortality [ Time Frame: 30 days ] COVID-19 related death among patients with HIV and COVID-19
Secondary Outcome Measures:
1.	Frequency of patients requiring hospital admissions [ Time Frame: 30 days ] Percentage of patients who required hospitalization
2.	Frequency of patients requiring ICU admissions [ Time Frame: 30 days ] Percentage of patients who required ICU admission
3.	Frequency of respiratory support use [ Time Frame: 30 days ] Percentage of patients who required respiratory support (new oxygen use, non-invasive ventilation,or invasive ventilation)
4.	Frequency of kidney injury [ Time Frame: 30 days ] Percentage of patients who developed acute kidney injury defined as increase in baseline creatinine, or use of renal replacement therapy
5.	Frequency of liver injury [ Time Frame: 30 days ] Percentage of patients who developed liver injury defined as increase in baseline ALT

Eligibility


Study Population:	Patients with HIV disease who are diagnosed with COVID-19, inpatient or outpatient
Sampling Method:	Non-Probability Sample
Minimum Age:
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: HIV disease Laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay Exclusion Criteria: None

Contacts/Locations


Locations:	United States, Missouri
	University of Missouri-Columbia [Recruiting] Columbia, Missouri, United States, 65212 Contact:Contact: Dima Dandachi, MD 573-884-8728 dandachid@health.missouri.edu

IPDSharing


Plan to Share IPD:	Undecided

References


Links:
Available IPD/Information: