Long-term Effects of COVID-19

Recruiting

• Conditions: COVID-19; SAR-CoV-2
• Interventions: Drug: (R)-1-(2-chlorophenyl)- N-[11C] ([11C] PK11195); Drug: 2-(4-[11C]methylamino phenyl)-6-hydroxybenzothiazole (11C]6-OH-BTA-1 or [11C]PIB)

• Registration Number: NCT05220514
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of this study is to measure, monitor, and analyze long term effects of SARS-CoV-2. The main purpose is to assess the post-hospitalization outcomes of patients who were diagnosed with SAR-CoV-2 by comparing to patients who were hospitalized with an acute neurological disease.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-10
• Study Start: 2022-01-19
• Study First Submitted QC: 2022-01-31
• Study First Posted: 2022-02-02
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-25
• Last Update Posted: 2024-04-26
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Control Participants: Males and females over the age of 18 years hospitalized and receiving intensive care for diagnosis's other than COVID-19 or an acute neurological disease and who were not diagnosed (clinically or with PCR testing) with COVID-19.
• Case Participants: Males and females over the age of 18 years who had been hospitalized at Mayo Clinic Hospital for treatment of COVID-19 confirmed by PCR test.
• We acknowledge that some participants may be unable to consent due to underlying medical conditions; an eligible proxy may provide the informed consent and provide a signature on the designated line.
• Women of childbearing age, between the ages of 18 to 55, must complete a negative pregnancy test.
• Minority individuals over the age of 18 years will be eligible to enroll.

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Exclusion Criteria

• Males and females, under the age of 18 years.
• Participants with PET/MRI non-compatible devices.
• Claustrophobia.
• Allergies to study related procedures.
• Pregnant , incarcerated, or institutionalized subjects will not be included in the study.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID-19 Diagnosis Case Group	2-(4-[11C]methylamino phenyl)-6-hydroxybenzothiazole (11C]6-OH-BTA-1 or [11C]PIB)	Subjects previously hospitalized at Mayo Clinic Hospital for treatment of PCR test confirmed COVID-19
Non-COVID-19 Diagnosis Control Group	(R)-1-(2-chlorophenyl)- N-[11C] ([11C] PK11195)	Subjects hospitalized and receiving intensive care for diagnosis of an acute neurological disease other than COVID-19
Non-COVID-19 Diagnosis Control Group	2-(4-[11C]methylamino phenyl)-6-hydroxybenzothiazole (11C]6-OH-BTA-1 or [11C]PIB)	Subjects hospitalized and receiving intensive care for diagnosis of an acute neurological disease other than COVID-19
COVID-19 Diagnosis Case Group	(R)-1-(2-chlorophenyl)- N-[11C] ([11C] PK11195)	Subjects previously hospitalized at Mayo Clinic Hospital for treatment of PCR test confirmed COVID-19

Primary Outcome Measures

Name	Time	Method
Change in neurological, cognitive, and functional trajectories in participants who are status post hospitalization for COVID-19 and participants receiving intensive care for diagnosis other than COVID-19	Baseline, 9 months, 12 months, 24 months.	Collect participants' self reported response from questionnaire: Montreal Cognitive Assessment

Trial Locations

Locations (1)

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States