Trial Outcomes & Findings for Endocrine, Metabolic and Microbiome Influence on the Post-acute Sequelae SARS-CoV-2 (PASC) (NCT NCT04860869)
NCT ID: NCT04860869
Last Updated: 2024-10-28
Results Overview
Insulin-Like Growth Factor-1 (IGF1) will be measured in serum. Results will be reported in ng/mL.
COMPLETED
23 participants
baseline
2024-10-28
Participant Flow
This study was conducted from May 2021 to May 2022. Subjects for PASC group were recruited from the UTMB post-COVID clinic. Subjects for the nPASC group were recruited from the community. All subjects were required to have a confirmed PCR diagnosis of SARS-CoV-2 at least 6 months prior to enrollment as well as confirmed negative at enrollment. Confirmed SARS-CoV-2 infection dates for subjects ranged from June 2020 to August 2021, before the emergence and dominance of the Omicron variant.
Participant milestones
| Measure |
Symptomatic Post-COVID (PASC)
Patients with post-acute sequelae of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (PASC)
|
Non-symptomatic Post-COVID (nPASC)
Patients with that recovered without lingering symptoms after being infected with post-acute sequelae of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
13
|
|
Overall Study
COMPLETED
|
9
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Symptomatic Post-COVID (PASC)
Patients with post-acute sequelae of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (PASC)
|
Non-symptomatic Post-COVID (nPASC)
Patients with that recovered without lingering symptoms after being infected with post-acute sequelae of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Endocrine, Metabolic and Microbiome Influence on the Post-acute Sequelae SARS-CoV-2 (PASC)
Baseline characteristics by cohort
| Measure |
Symptomatic Post-COVID
n=10 Participants
10 patients with Post-COVID syndrome
|
Non-symptomatic Post-COVID
n=13 Participants
13 patients with that recovered without lingering symptoms after being infected with COVID
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
48.5 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
46.8 years
STANDARD_DEVIATION 14.9 • n=7 Participants
|
47.6 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Days post-diagnosis
|
293.9 days
STANDARD_DEVIATION 97.1 • n=5 Participants
|
473.0 days
STANDARD_DEVIATION 145.8 • n=7 Participants
|
395.1 days
STANDARD_DEVIATION 153.9 • n=5 Participants
|
|
COVID Hospitalization
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Height
|
164.2 cm
STANDARD_DEVIATION 9.8 • n=5 Participants
|
170.7 cm
STANDARD_DEVIATION 8.8 • n=7 Participants
|
167.9 cm
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Weight
|
85.2 kg
STANDARD_DEVIATION 23.0 • n=5 Participants
|
90.3 kg
STANDARD_DEVIATION 16.4 • n=7 Participants
|
88 kg
STANDARD_DEVIATION 19.2 • n=5 Participants
|
|
BMI
|
31.2 (kg/m^2)
STANDARD_DEVIATION 5.9 • n=5 Participants
|
30.9 (kg/m^2)
STANDARD_DEVIATION 4.5 • n=7 Participants
|
31.0 (kg/m^2)
STANDARD_DEVIATION 5.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: baselineInsulin-Like Growth Factor-1 (IGF1) will be measured in serum. Results will be reported in ng/mL.
Outcome measures
| Measure |
Symptomatic Post-COVID
n=10 Participants
Patients with Post-COVID syndrome
|
Non-symptomatic Post-COVID
n=13 Participants
Patients with that recovered without lingering symptoms after being infected with COVID
|
|---|---|---|
|
Insulin-Like Growth Factor-1 (IGF1)
|
142.8 ng/ml
Standard Deviation 41.6
|
137.6 ng/ml
Standard Deviation 56.7
|
PRIMARY outcome
Timeframe: baselineFollicle Stimulation Hormone (FSH) will be measured in serum.
Outcome measures
| Measure |
Symptomatic Post-COVID
n=10 Participants
Patients with Post-COVID syndrome
|
Non-symptomatic Post-COVID
n=13 Participants
Patients with that recovered without lingering symptoms after being infected with COVID
|
|---|---|---|
|
Follicle Stimulating Hormone (FSH)
|
38.2 mIU/ml
Standard Deviation 35.3
|
24.1 mIU/ml
Standard Deviation 32.7
|
PRIMARY outcome
Timeframe: baselineSex Hormone Binding Globulin (SHBG) will be measured in serum. Results will be reported in nmol/L.
Outcome measures
| Measure |
Symptomatic Post-COVID
n=10 Participants
Patients with Post-COVID syndrome
|
Non-symptomatic Post-COVID
n=13 Participants
Patients with that recovered without lingering symptoms after being infected with COVID
|
|---|---|---|
|
Sex Hormone Binding Globulin (SHBG)
|
46.4 nmol/L
Standard Deviation 25.0
|
97.7 nmol/L
Standard Deviation 85.8
|
PRIMARY outcome
Timeframe: baselinePopulation: Testosterone reported in male subjects only
Total testosterone will be measured in serum of male subjects. Results will be reported in ng/dL.
Outcome measures
| Measure |
Symptomatic Post-COVID
n=2 Participants
Patients with Post-COVID syndrome
|
Non-symptomatic Post-COVID
n=4 Participants
Patients with that recovered without lingering symptoms after being infected with COVID
|
|---|---|---|
|
Total Testosterone
|
508.0 ng/dl
Standard Deviation 81.2
|
292.5 ng/dl
Standard Deviation 53.0
|
PRIMARY outcome
Timeframe: baselinePopulation: Free testosterone measured in males only
Free testosterone will be measured in serum of male subjects. Results will be reported in pg/mL.
Outcome measures
| Measure |
Symptomatic Post-COVID
n=2 Participants
Patients with Post-COVID syndrome
|
Non-symptomatic Post-COVID
n=4 Participants
Patients with that recovered without lingering symptoms after being infected with COVID
|
|---|---|---|
|
Free Testosterone
|
27.9 pg/ml
Standard Deviation 37.0
|
76.0 pg/ml
Standard Deviation 4.6
|
PRIMARY outcome
Timeframe: baselineProlactin will be measured in serum. Results will be reported in ng/mL.
Outcome measures
| Measure |
Symptomatic Post-COVID
n=10 Participants
Patients with Post-COVID syndrome
|
Non-symptomatic Post-COVID
n=13 Participants
Patients with that recovered without lingering symptoms after being infected with COVID
|
|---|---|---|
|
Prolactin
|
11.5 ng/ml
Standard Deviation 9.5
|
9.5 ng/ml
Standard Deviation 4.0
|
PRIMARY outcome
Timeframe: baselineThyroid Stimulating Hormone (TSH) will be measured in serum. Results will be reported in mUI/L.
Outcome measures
| Measure |
Symptomatic Post-COVID
n=10 Participants
Patients with Post-COVID syndrome
|
Non-symptomatic Post-COVID
n=13 Participants
Patients with that recovered without lingering symptoms after being infected with COVID
|
|---|---|---|
|
Thyroid Stimulating Hormone (TSH)
|
2.38 mUI/L
Standard Deviation 1.27
|
1.60 mUI/L
Standard Deviation 0.95
|
PRIMARY outcome
Timeframe: baselineC Reactive Protein (CRP) will be measured in serum.
Outcome measures
| Measure |
Symptomatic Post-COVID
n=10 Participants
Patients with Post-COVID syndrome
|
Non-symptomatic Post-COVID
n=13 Participants
Patients with that recovered without lingering symptoms after being infected with COVID
|
|---|---|---|
|
C Reactive Protein (CRP)
|
0.47 mg/dl
Standard Deviation 0.46
|
0.38 mg/dl
Standard Deviation 0.57
|
PRIMARY outcome
Timeframe: baselineVitamin B12 will be measured in serum.
Outcome measures
| Measure |
Symptomatic Post-COVID
n=10 Participants
Patients with Post-COVID syndrome
|
Non-symptomatic Post-COVID
n=13 Participants
Patients with that recovered without lingering symptoms after being infected with COVID
|
|---|---|---|
|
Vitamin B12
|
553.7 pg/ml
Standard Deviation 156.4
|
446.1 pg/ml
Standard Deviation 254.3
|
PRIMARY outcome
Timeframe: baselineVitamin D 25OH will be measured in serum.
Outcome measures
| Measure |
Symptomatic Post-COVID
n=10 Participants
Patients with Post-COVID syndrome
|
Non-symptomatic Post-COVID
n=13 Participants
Patients with that recovered without lingering symptoms after being infected with COVID
|
|---|---|---|
|
Vitamin D 25OH
|
30.6 ng/ml
Standard Deviation 8.6
|
41.1 ng/ml
Standard Deviation 10.7
|
PRIMARY outcome
Timeframe: Before glucose consumptionPopulation: PASC subjects only
Glucose will be measured in serum before (0 minutes) oral consumption of 75g glucose. OGTT will be performed on PASC subjects only.
Outcome measures
| Measure |
Symptomatic Post-COVID
n=9 Participants
Patients with Post-COVID syndrome
|
Non-symptomatic Post-COVID
Patients with that recovered without lingering symptoms after being infected with COVID
|
|---|---|---|
|
Glucose Tolerance as Measured by the Oral Glucose Tolerance Test (OGTT) Before Glucose Consumption
|
91.9 mg/dl
Standard Deviation 6.9
|
—
|
PRIMARY outcome
Timeframe: 120 minutes after glucose consumptionPopulation: OGTT will be performed on PASC subjects only.
Glucose will be measured in serum at 120 minutes after oral consumption of 75g glucose. OGTT will be performed on PASC subjects only.
Outcome measures
| Measure |
Symptomatic Post-COVID
n=9 Participants
Patients with Post-COVID syndrome
|
Non-symptomatic Post-COVID
Patients with that recovered without lingering symptoms after being infected with COVID
|
|---|---|---|
|
Glucose Tolerance as Measured by the Oral Glucose Tolerance Test (OGTT) 120 Minutes After Glucose Consumption
|
150.3 mg/dl
Standard Deviation 33.7
|
—
|
PRIMARY outcome
Timeframe: Before glucose consumptionPopulation: OGTT will be performed on PASC subjects only. 2 subjects from PASC are missing this analysis.
Insulin will be measured in serum before (0 min) oral consumption of 75g glucose. OGTT will be performed on PASC subjects only.
Outcome measures
| Measure |
Symptomatic Post-COVID
n=8 Participants
Patients with Post-COVID syndrome
|
Non-symptomatic Post-COVID
Patients with that recovered without lingering symptoms after being infected with COVID
|
|---|---|---|
|
Insulin as Measured by the Oral Glucose Tolerance Test (OGTT) Before Glucose Consumption
|
7.4 uIU/ml
Standard Deviation 4.4
|
—
|
PRIMARY outcome
Timeframe: 120 minutes after glucose consumptionPopulation: OGTT will be performed on PASC subjects only. 2 subjects from the PASC group are missing from analysis for this measure.
Insulin will be measured in serum at 120 minutes after oral consumption of 75g glucose. OGTT will be performed on PASC subjects only.
Outcome measures
| Measure |
Symptomatic Post-COVID
n=8 Participants
Patients with Post-COVID syndrome
|
Non-symptomatic Post-COVID
Patients with that recovered without lingering symptoms after being infected with COVID
|
|---|---|---|
|
Insulin as Measured by the Oral Glucose Tolerance Test (OGTT) 120 Minutes After Glucose Consumption
|
82.0 uIU/ml
Standard Deviation 46.7
|
—
|
PRIMARY outcome
Timeframe: 120 minutes after glucose consumptionPopulation: OGTT will be performed on PASC subjects only.
Glucose derived CO2 will be measured in breath samples at 120 minutes after oral consumption of 75g glucose isotopically labeled with 150 mg \[U-13C6\] glucose. Glucose-derived breath CO2 data are analyzed by measuring the ratios of 13CO2 to 12CO2 in single breath samples using an UBiT-IR300 infrared spectrophotometer (Otsuka Electronics, Hirakata, Osaka, Japan). The UBIT-IR300 calculates the difference in 13CO2 abundance from the baseline breath sample to each timed sample and expresses this as per mille delta over baseline (%DOB). OGTT will be performed on PASC subjects only.
Outcome measures
| Measure |
Symptomatic Post-COVID
n=10 Participants
Patients with Post-COVID syndrome
|
Non-symptomatic Post-COVID
Patients with that recovered without lingering symptoms after being infected with COVID
|
|---|---|---|
|
Glucose Derived CO2 as Measured by Breath During the Oral Glucose Tolerance Test (OGTT) 120 Minutes After Glucose Consumption
|
40.9 %DOB
Standard Deviation 12.6
|
—
|
PRIMARY outcome
Timeframe: baselinePopulation: 1 PASC subject missing from analysis
Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1 month-time interval. Minimum Score = 0 (better); Maximum Score = 21 (worse). Interpretation: Total \< 5 associated with good sleep quality. Total \> 5 associated with poor sleep quality.
Outcome measures
| Measure |
Symptomatic Post-COVID
n=9 Participants
Patients with Post-COVID syndrome
|
Non-symptomatic Post-COVID
n=13 Participants
Patients with that recovered without lingering symptoms after being infected with COVID
|
|---|---|---|
|
Sleep Quality as Measured by Pittsburgh Sleep Quality Index
|
11.1 score on a scale
Standard Deviation 4.0
|
4.5 score on a scale
Standard Deviation 2.8
|
PRIMARY outcome
Timeframe: Before glucagon administrationPopulation: One PASC patient is missing from this measure
Growth hormone secretion will be measured using the glucagon stimulation test. Serum will be collected for the baseline (time: 0 minutes) to test for levels of human growth hormone. 1 mg glucagon (for subjects over 90 kg, 1.5 mg glucagon) will be injected intramuscularly (IM) in the deltoid muscle of the subject and blood will be drawn at specified time points. Results will be reported as ng/mL.
Outcome measures
| Measure |
Symptomatic Post-COVID
n=9 Participants
Patients with Post-COVID syndrome
|
Non-symptomatic Post-COVID
n=13 Participants
Patients with that recovered without lingering symptoms after being infected with COVID
|
|---|---|---|
|
Growth Hormone as Measured by Glucagon Stimulation Test Before Glucagon Administration
|
0.4 ng/ml
Standard Deviation 0.6
|
0.9 ng/ml
Standard Deviation 0.8
|
PRIMARY outcome
Timeframe: 90 minutes after glucagon administrationPopulation: One PASC patient is missing from this measure
Growth hormone secretion will be measured using the glucagon stimulation test. Serum will be collected at time point 90 minutes after glucagon injection to test for levels of human growth hormone. Results will be reported as ng/mL.
Outcome measures
| Measure |
Symptomatic Post-COVID
n=9 Participants
Patients with Post-COVID syndrome
|
Non-symptomatic Post-COVID
n=13 Participants
Patients with that recovered without lingering symptoms after being infected with COVID
|
|---|---|---|
|
Growth Hormone as Measured by Glucagon Stimulation Test 90 Minutes After Glucagon Administration
|
0.6 ng/ml
Standard Deviation 0.5
|
1.6 ng/ml
Standard Deviation 3.5
|
PRIMARY outcome
Timeframe: 120 minutes after glucagon administrationPopulation: One PASC patient is missing from this measure.
Growth hormone secretion will be measured using the glucagon stimulation test. Serum will be collected at timepoint 120 minutes after glucagon injection to test for levels of growth hormone. Results will be reported as ng/mL.
Outcome measures
| Measure |
Symptomatic Post-COVID
n=9 Participants
Patients with Post-COVID syndrome
|
Non-symptomatic Post-COVID
n=13 Participants
Patients with that recovered without lingering symptoms after being infected with COVID
|
|---|---|---|
|
Growth Hormone as Measured by Glucagon Stimulation Test 120 Minutes After Glucagon Administration
|
2.2 ng/ml
Standard Deviation 2.5
|
5.6 ng/ml
Standard Deviation 6.0
|
PRIMARY outcome
Timeframe: 150 minutes after glucagon administrationPopulation: One PASC patient is missing from this measure.
Growth hormone secretion will be measured using the glucagon stimulation test. Serum will be collected at timepoint 150 minutes after glucagon injection to test for levels of growth hormone. Results will be reported as ng/mL.
Outcome measures
| Measure |
Symptomatic Post-COVID
n=9 Participants
Patients with Post-COVID syndrome
|
Non-symptomatic Post-COVID
n=13 Participants
Patients with that recovered without lingering symptoms after being infected with COVID
|
|---|---|---|
|
Growth Hormone as Measured by Glucagon Stimulation Test 150 Minutes After Glucagon Administration
|
2.6 ng/ml
Standard Deviation 2.1
|
5.8 ng/ml
Standard Deviation 3.5
|
PRIMARY outcome
Timeframe: 180 minutes after glucagon administrationPopulation: One PASC patient is missing from this measure.
Growth hormone secretion will be measured using the glucagon stimulation test. Serum will be collected at timepoint 180 minutes after glucagon injection to test for levels of growth hormone. Results will be reported as ng/mL.
Outcome measures
| Measure |
Symptomatic Post-COVID
n=9 Participants
Patients with Post-COVID syndrome
|
Non-symptomatic Post-COVID
n=13 Participants
Patients with that recovered without lingering symptoms after being infected with COVID
|
|---|---|---|
|
Growth Hormone as Measured by Glucagon Stimulation Test 180 Minutes After Glucagon Administration
|
2.3 ng/ml
Standard Deviation 1.9
|
3.0 ng/ml
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: baselinePopulation: PASC patients only. 2 patients from the PASC group are missing from measure.
Resting Energy Expenditure will be measured by capturing the expired breath of subjects while at rest with a metabolic cart over a 30 minute time period. Data from the first 5 minutes will be discarded and the remaining 25 minutes of data will be averaged to calculate the resting energy expenditure. Data will be reported as kilocalories/day Procedure will be performed on PASC subjects only.
Outcome measures
| Measure |
Symptomatic Post-COVID
n=8 Participants
Patients with Post-COVID syndrome
|
Non-symptomatic Post-COVID
Patients with that recovered without lingering symptoms after being infected with COVID
|
|---|---|---|
|
Basal Metabolic Rate as Measured by Resting Energy Expenditure
|
1489.2 kcal/day
Standard Deviation 257.7
|
—
|
PRIMARY outcome
Timeframe: Before Cortrosyn administrationPopulation: PASC patients only. 1 PASC patient is missing from measure.
Cortisol secretion will be measured using the ACTH stimulation test. Serum will be collected for the baseline (time: 0 minutes) to test for levels of cortisol. 0.25 mg Cortrosyn will be administered and additional serum (3.5 mL) will be collected at specified time points. Results will be reported as ug/dL. Procedure will be performed on PASC subjects only.
Outcome measures
| Measure |
Symptomatic Post-COVID
n=9 Participants
Patients with Post-COVID syndrome
|
Non-symptomatic Post-COVID
Patients with that recovered without lingering symptoms after being infected with COVID
|
|---|---|---|
|
Cortisol as Measured by the Adrenocorticotropic Hormone Stimulation Test (ACTH) Before Cortrosyn Administration
|
5.3 ug/dl
Standard Deviation 2.3
|
—
|
PRIMARY outcome
Timeframe: 30 minutes after Cortrosyn administrationPopulation: PASC patients only 1 PASC patient missing from measure
Cortisol secretion will be measured using the ACTH stimulation test. Serum will be collected at time point 30 minutes after Cortrosyn administration to test for levels of cortisol. Procedure will be performed on PASC subjects only. Results will be reported as ug/dL.
Outcome measures
| Measure |
Symptomatic Post-COVID
n=9 Participants
Patients with Post-COVID syndrome
|
Non-symptomatic Post-COVID
Patients with that recovered without lingering symptoms after being infected with COVID
|
|---|---|---|
|
Cortisol as Measured by the Adrenocorticotropic Hormone Stimulation Test (ACTH) 30 Minutes After Cortrosyn Administration
|
17.9 ug/dl
Standard Deviation 2.4
|
—
|
PRIMARY outcome
Timeframe: 60 minutes after Cortrosyn administrationPopulation: PASC patients only. 1 PASC patient missing from measure.
Cortisol secretion will be measured using the ACTH stimulation test. Serum will be collected at time point 60 minutes after Cortrosyn administration to test for levels of cortisol. Results will be reported as ug/dL. Procedure will be performed on PASC subjects only.
Outcome measures
| Measure |
Symptomatic Post-COVID
n=9 Participants
Patients with Post-COVID syndrome
|
Non-symptomatic Post-COVID
Patients with that recovered without lingering symptoms after being infected with COVID
|
|---|---|---|
|
Cortisol as Measured by the Adrenocorticotropic Hormone Stimulation Test (ACTH) 60 Minutes After Cortrosyn Administration
|
21.7 ug/dl
Standard Deviation 2.6
|
—
|
PRIMARY outcome
Timeframe: baselinePopulation: 1 PASC patient missing from measure
The Montreal Cognitive Assessment (MoCA) will be used to assess cognition. The Montreal Cognitive Assessment (MoCA) is a rapid assessment of cognition. The MoCA consists of 9 questions with the following subcategories: visuospatial/executive, naming, memory, language, abstraction, delayed recall and orientation. The MoCA has been used extensively to detect cognitive impairment in many conditions, including head trauma. Version 7.1 will be used. Scores range from 0 to 30, higher score being a better outcome.
Outcome measures
| Measure |
Symptomatic Post-COVID
n=9 Participants
Patients with Post-COVID syndrome
|
Non-symptomatic Post-COVID
n=13 Participants
Patients with that recovered without lingering symptoms after being infected with COVID
|
|---|---|---|
|
Cognitive Function as Measured by Montreal Cognitive Assessment
|
27.0 units on a scale
Standard Deviation 2.5
|
27.9 units on a scale
Standard Deviation 2.8
|
PRIMARY outcome
Timeframe: baselinePopulation: 1 PASC patient is missing from this measure.
The Gastrointestinal Symptom Rating Scale (GSRS) is a specific 15-item questionnaire. Subjects are asked to numerically score their subjective symptoms on a scale of 1-7 (1 = no discomfort at all; 7 = very severe discomfort). The average of the scores for all 15 items is regarded as the GSRS total score. A higher score indicates a worse outcome.
Outcome measures
| Measure |
Symptomatic Post-COVID
n=9 Participants
Patients with Post-COVID syndrome
|
Non-symptomatic Post-COVID
n=13 Participants
Patients with that recovered without lingering symptoms after being infected with COVID
|
|---|---|---|
|
Gastrointestinal Health Measured by the Gastrointestinal Symptom Rating Scale
|
2.5 units on a scale
Standard Deviation 1.0
|
1.4 units on a scale
Standard Deviation 0.4
|
PRIMARY outcome
Timeframe: baselinePopulation: 1 PASC patient is missing from this measure
Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the total score is -24 to 96, with the higher the number meaning more fatigue.
Outcome measures
| Measure |
Symptomatic Post-COVID
n=9 Participants
Patients with Post-COVID syndrome
|
Non-symptomatic Post-COVID
n=13 Participants
Patients with that recovered without lingering symptoms after being infected with COVID
|
|---|---|---|
|
Fatigue as Measured by the Multidimensional Fatigue Symptom Inventory
|
31.0 units on a scale
Standard Deviation 17.3
|
-14.0 units on a scale
Standard Deviation 7.4
|
PRIMARY outcome
Timeframe: baselinePopulation: 1 PASC patient is missing from this measure.
Symptoms of growth hormone deficiency will be measured using the Quality of Life - Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA). This 25-item questionnaire measures specific symptoms associated with growth hormone deficiency, with a score range of 0 to 25, with a higher score indicating worse symptoms.
Outcome measures
| Measure |
Symptomatic Post-COVID
n=9 Participants
Patients with Post-COVID syndrome
|
Non-symptomatic Post-COVID
n=13 Participants
Patients with that recovered without lingering symptoms after being infected with COVID
|
|---|---|---|
|
Symptoms of Growth Hormone Deficiency Measured by the Questionnaire Quality of Life - Assessment of Growth Hormone Deficiency in Adults
|
13.6 units on a scale
Standard Deviation 7.0
|
2.4 units on a scale
Standard Deviation 5.1
|
PRIMARY outcome
Timeframe: baselinePopulation: 1 PASC patient is missing from this measure.
The Beck Depression Inventory- II (BDI-II) assesses depressive symptom severity. The BDI-II is comprised of 21 individual items reflecting specific cognitive, affective, and physical symptoms of depression. Each item includes four statements that vary in the description of symptom of severity. Scores range from 0 to 3, with a score of "3" indicating a severe symptoms and a score of "0" indicating an absence of concern with that particular aspect of depressive symptomology. The total score is the sum of all endorsed statements. The maximum total score is 63. The BDI-II Manual designates the following raw score classifications depression severity: ≤13 = minimal; 14-19 = mild; 20-28 = moderate; ≥ 29 = severe.
Outcome measures
| Measure |
Symptomatic Post-COVID
n=9 Participants
Patients with Post-COVID syndrome
|
Non-symptomatic Post-COVID
n=13 Participants
Patients with that recovered without lingering symptoms after being infected with COVID
|
|---|---|---|
|
Depression Measured by the Beck Depression Inventory-II
|
16.8 units on a scale
Standard Deviation 10.7
|
2.2 units on a scale
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: baselineFree T4 measured at baseline
Outcome measures
| Measure |
Symptomatic Post-COVID
n=10 Participants
Patients with Post-COVID syndrome
|
Non-symptomatic Post-COVID
n=13 Participants
Patients with that recovered without lingering symptoms after being infected with COVID
|
|---|---|---|
|
Free T4
|
1.05 ng/dl
Standard Deviation 0.16
|
1.19 ng/dl
Standard Deviation 0.20
|
Adverse Events
Symptomatic Post-COVID (PASC)
Non-symptomatic Post-COVID (nPASC)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place