REsearching Covid-19 Outcomes in Diabetes (RECODE) | NCT04805970

Studies
REsearching Covid-19 Outcomes in Diabetes (RECODE)

NCT04805970

Sponsor

AdventHealth Translational Research Institute

Status

Active, not recruiting

Last Update Posted

Mar 30, 2026Actual

Enrollment

35Actual

Phase

Not provided

Conditions

Covid19
Diabetes

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 24, 2021Actual

Primary Completion Date

Oct 22, 2024Actual

Completion Date

Dec 2026Estimated

First Submitted Date

Mar 17, 2021

First Submission Date that Met QC Criteria

Mar 17, 2021

First Posted Date

Mar 18, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2026

Last Update Posted Date

Mar 30, 2026Actual

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Label	Type	Description	Intervention Names
Patients with and without diabetes who were previously diagnosed with COVID-19

Measure	Description	Time Frame
Measure and characterize organ volume change in patients with and without diabetes through use of summary statistics.	Patients recovering from the COVID-19 disease	1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

For Type 2 Diabetes (T2D)

Male or female 18 years of age and older willing and able to give informed consent to participate in the study
Confirmed diagnosis of SARS-CoV-2 RNA via a polymerase chain reaction (PCR) assay (having been discharged at least 2 months from hospital but not greater than 6 months).
Diagnosis of T2D according to American Diabetes Association (ADA) criteria.
Must have access to a computer/laptop or a modern (no more than 3-4 years old) smart phone/tablet for cognitive assessments.

For participant without Type 2 Diabetes (T2D)

Male or female 18 years of age and older willing and able to give informed consent to participate in the study
Confirmed diagnosis of SARS-CoV-2 RNA via a polymerase chain reaction (PCR) assay (having been discharged at least 2 months from hospital but not greater than 6 months).
Must have access to a computer/laptop or a modern (no more than 3-4 years old) smart phone/tablet for cognitive assessments.

Exclusion Criteria:

Symptoms of active respiratory viral infection:
1. high temperature (over 37.8°C/100.4°F)
2. cough (consistent for over an hour; 3 or more episodes in 24 hours)
Any history of Type I diabetes
The participant may not enter the study with any known contraindication to magnetic resonance imaging including
1. Pregnancy, lactation or 6 months postpartum from the scheduled date of collection
2. Metal implants (pacemaker, aneurysm clips) based on Investigator's judgment at Screening
3. Unable to participate in MRI assessments due to physical limitations of equipment tolerances (e.g. MRI bore size) based on Investigator's judgment at Screening
4. Unable to tolerate MRI imaging or claustrophobia
Any condition, including a significant underlying disease or disorder which, in the opinion of the investigator, may put the participant at risk by participating in the study or limit the participant's ability to participate.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who were initially hospitalized with laboratory-confirmed SARS-CoV-2 infection [COVID-19 disease], who are no-longer considered infectious by approved bioassay

Sampling Method

Non-Probability Sample

ID	Term
D000086382	COVID-19
D003920	Diabetes Mellitus

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections