Trial Outcomes & Findings for COVID-19 Observational Research Collaboratory (NCT NCT05394025)

NCT ID: NCT05394025

Last Updated: 2025-08-07

Results Overview

Measures level of disability on a scale from 0 - 14, where higher values are considered a worse outcome. Multiple survey timepoints will allow us to assess change in disability over time. The score consists of 14 questions about activities of daily living. The I/ADL score is a sum total of reported limitations ranging from 0 (no limitations reported) to 14 (limitations in all activities asked reported).

Recruitment status

COMPLETED

Target enrollment

479 participants

Primary outcome timeframe

Survey months 18, 24, 30, 36

Results posted on

2025-08-07

Participant Flow

We retrospectively assembled 14 monthly cohorts of Veterans with a first positive test for COVID-19 and up to 20 matched uninfected comparators between March 2020 and April 2021. Survey participants were sampled from this parent cohort. First, we randomly sampled 100 Veterans with COVID-19 from each month between Oct 2020 and April 2021. Sampled Veterans were invited to participate in surveys. If a sampled Veteran consented, we reached out to five of their matched comparators to participate.

Participant milestones

Participant milestones
Measure
Veterans Who Tested Positive for COVID-19 (Case)
A random sample of Veterans who tested positive for COVID-19 between October 2020 and April 2021. The sampled Veterans who survived their initial SARS-CoV-2 infection were invited to participate in a series of four longitudinal surveys beginning approximately 18 months after their infection (or "index date"). After the first survey 18-month survey was completed, Veterans were contacted every 6-months to complete a follow-up survey up until 36-months after their initial infection or index date. In this arm, 235 consented and completed the initial survey and 220 completed all four surveys.
Veterans Who Did Not Test Positive for COVID-19 (Comparator)
To support causal inference, the investigators will also sample up to five comparator Veterans without COVID who are matched to participants with COVID-19 (within the same month of their infection). In general, cases will be compared to comparators matched on risk of developing COVID infection during a given wave. The five uninfected comparators were contacted after the matched index Veteran (case) consented to participate in surveys. The uninfected comparators were given the same series of surveys (four total beginning 18-months after their matched index date). In this arm, 244 consented and completed the initial survey and 220 completed all four.
Overall Study
STARTED
235
244
Overall Study
COMPLETED
220
220
Overall Study
NOT COMPLETED
15
24

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

COVID-19 Observational Research Collaboratory

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Veterans Who Tested Positive for COVID-19 (Case)
n=235 Participants
The investigators will organize the sampling of cases (and later of comparators) around the waves of the epidemic, as defined by their nadirs between national death rates-each approximately 3-4 months long. The investigators will initiate surveys of Veterans who have survived their initial SARS-CoV-2 infection. The viral infection "index date" will be defined as date of each patient's first positive test.
Veterans Who Did Not Test Positive for COVID-19 (Comparator)
n=244 Participants
To support causal inference, the investigators will also sample Veterans without COVID who are matched to participants with COVID-19. In general, cases will be compared to comparators matched on risk of developing COVID infection during a given wave.
Total
n=479 Participants
Total of all reporting groups
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty preparing a hot meal? · Can't do
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Continuous
61 years
n=5 Participants
62 years
n=7 Participants
61 years
n=5 Participants
Sex/Gender, Customized
Sex · Female
23 Participants
n=5 Participants
20 Participants
n=7 Participants
43 Participants
n=5 Participants
Sex/Gender, Customized
Sex · Male
183 Participants
n=5 Participants
124 Participants
n=7 Participants
307 Participants
n=5 Participants
Sex/Gender, Customized
Sex · Unknown
29 Participants
n=5 Participants
100 Participants
n=7 Participants
129 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
14 Participants
n=5 Participants
16 Participants
n=7 Participants
30 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
187 Participants
n=5 Participants
127 Participants
n=7 Participants
314 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
34 Participants
n=5 Participants
101 Participants
n=7 Participants
135 Participants
n=5 Participants
Race/Ethnicity, Customized
Race · Black
48 Participants
n=5 Participants
36 Participants
n=7 Participants
84 Participants
n=5 Participants
Race/Ethnicity, Customized
Race · White
145 Participants
n=5 Participants
98 Participants
n=7 Participants
243 Participants
n=5 Participants
Race/Ethnicity, Customized
Race · Other
4 Participants
n=5 Participants
4 Participants
n=7 Participants
8 Participants
n=5 Participants
Race/Ethnicity, Customized
Race · Unknown
38 Participants
n=5 Participants
106 Participants
n=7 Participants
144 Participants
n=5 Participants
Region of Enrollment
United States
235 participants
n=5 Participants
244 participants
n=7 Participants
479 participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty dressing, including putting on shoes and socks · No
161 Participants
n=5 Participants
178 Participants
n=7 Participants
339 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty dressing, including putting on shoes and socks · Yes
63 Participants
n=5 Participants
57 Participants
n=7 Participants
120 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty dressing, including putting on shoes and socks · Don't do
10 Participants
n=5 Participants
5 Participants
n=7 Participants
15 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty dressing, including putting on shoes and socks · Can't do
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty dressing, including putting on shoes and socks · Unknown
1 Participants
n=5 Participants
4 Participants
n=7 Participants
5 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty walking across room? · No
171 Participants
n=5 Participants
177 Participants
n=7 Participants
348 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty walking across room? · Yes
62 Participants
n=5 Participants
63 Participants
n=7 Participants
125 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty walking across room? · Don't do
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty walking across room? · Can't do
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty walking across room? · Unknown
1 Participants
n=5 Participants
4 Participants
n=7 Participants
5 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty bathing or showering? · No
185 Participants
n=5 Participants
191 Participants
n=7 Participants
376 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty bathing or showering? · Yes
49 Participants
n=5 Participants
48 Participants
n=7 Participants
97 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty bathing or showering? · Don't do
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty bathing or showering? · Can't do
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty bathing or showering? · Unknown
1 Participants
n=5 Participants
5 Participants
n=7 Participants
6 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty eating? · No
219 Participants
n=5 Participants
224 Participants
n=7 Participants
443 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty eating? · Yes
14 Participants
n=5 Participants
16 Participants
n=7 Participants
30 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty eating? · Don't do
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty eating? · Can't do
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty eating? · Unknown
2 Participants
n=5 Participants
4 Participants
n=7 Participants
6 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty getting in or out of bed? · No
168 Participants
n=5 Participants
172 Participants
n=7 Participants
340 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty getting in or out of bed? · Yes
65 Participants
n=5 Participants
68 Participants
n=7 Participants
133 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty getting in or out of bed? · Don't do
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty getting in or out of bed? · Can't do
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty getting in or out of bed? · Unknown
1 Participants
n=5 Participants
4 Participants
n=7 Participants
5 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty using toilet? · No
184 Participants
n=5 Participants
196 Participants
n=7 Participants
380 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty using toilet? · Yes
50 Participants
n=5 Participants
42 Participants
n=7 Participants
92 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty using toilet? · Don't do
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty using toilet? · Can't do
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty using toilet? · Unknown
1 Participants
n=5 Participants
5 Participants
n=7 Participants
6 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty using map? · No
199 Participants
n=5 Participants
217 Participants
n=7 Participants
416 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty using map? · Yes
30 Participants
n=5 Participants
21 Participants
n=7 Participants
51 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty using map? · Don't do
4 Participants
n=5 Participants
2 Participants
n=7 Participants
6 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty using map? · Can't do
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty using map? · Unknown
2 Participants
n=5 Participants
4 Participants
n=7 Participants
6 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty shopping for groceries? · No
161 Participants
n=5 Participants
178 Participants
n=7 Participants
339 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty shopping for groceries? · Yes
63 Participants
n=5 Participants
57 Participants
n=7 Participants
120 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty shopping for groceries? · Don't do
10 Participants
n=5 Participants
5 Participants
n=7 Participants
15 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty shopping for groceries? · Can't do
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty shopping for groceries? · Unknown
1 Participants
n=5 Participants
4 Participants
n=7 Participants
5 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty preparing a hot meal? · No
201 Participants
n=5 Participants
203 Participants
n=7 Participants
404 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty preparing a hot meal? · Yes
24 Participants
n=5 Participants
32 Participants
n=7 Participants
56 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty preparing a hot meal? · Don't do
9 Participants
n=5 Participants
5 Participants
n=7 Participants
14 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty preparing a hot meal? · Unknown
1 Participants
n=5 Participants
4 Participants
n=7 Participants
5 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty making phone calls? · No
209 Participants
n=5 Participants
226 Participants
n=7 Participants
435 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty making phone calls? · Yes
25 Participants
n=5 Participants
14 Participants
n=7 Participants
39 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty making phone calls? · Don't do
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty making phone calls? · Can't do
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty making phone calls? · Unknown
1 Participants
n=5 Participants
4 Participants
n=7 Participants
5 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty making medications? · No
188 Participants
n=5 Participants
208 Participants
n=7 Participants
396 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty making medications? · Yes
42 Participants
n=5 Participants
30 Participants
n=7 Participants
72 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty making medications? · Don't do
4 Participants
n=5 Participants
1 Participants
n=7 Participants
5 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty making medications? · Can't do
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty making medications? · Unknown
1 Participants
n=5 Participants
5 Participants
n=7 Participants
6 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty managing money? · No
180 Participants
n=5 Participants
200 Participants
n=7 Participants
380 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty managing money? · Yes
48 Participants
n=5 Participants
35 Participants
n=7 Participants
83 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty managing money? · Don't do
6 Participants
n=5 Participants
5 Participants
n=7 Participants
11 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty managing money? · Can't do
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty managing money? · Unknown
1 Participants
n=5 Participants
4 Participants
n=7 Participants
5 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty stooping or kneeling? · No
63 Participants
n=5 Participants
81 Participants
n=7 Participants
144 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty stooping or kneeling? · Yes
166 Participants
n=5 Participants
155 Participants
n=7 Participants
321 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty stooping or kneeling? · Don't do
2 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty stooping or kneeling? · Can't do
3 Participants
n=5 Participants
3 Participants
n=7 Participants
6 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty stooping or kneeling? · Unknown
1 Participants
n=5 Participants
5 Participants
n=7 Participants
6 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty lifting over 10 pounds? · No
135 Participants
n=5 Participants
138 Participants
n=7 Participants
273 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty lifting over 10 pounds? · Yes
93 Participants
n=5 Participants
100 Participants
n=7 Participants
193 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty lifting over 10 pounds? · Don't do
1 Participants
n=5 Participants
2 Participants
n=7 Participants
3 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty lifting over 10 pounds? · Can't do
5 Participants
n=5 Participants
0 Participants
n=7 Participants
5 Participants
n=5 Participants
Baseline Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL)
Difficulty lifting over 10 pounds? · Unknown
1 Participants
n=5 Participants
4 Participants
n=7 Participants
5 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Survey months 18, 24, 30, 36

Measures level of disability on a scale from 0 - 14, where higher values are considered a worse outcome. Multiple survey timepoints will allow us to assess change in disability over time. The score consists of 14 questions about activities of daily living. The I/ADL score is a sum total of reported limitations ranging from 0 (no limitations reported) to 14 (limitations in all activities asked reported).

Outcome measures

Outcome measures
Measure
Veterans Who Tested Positive for COVID-19 (Case)
n=235 Participants
The investigators will organize the sampling of cases (and later of comparators) around the waves of the epidemic, as defined by their nadirs between national death rates-each approximately 3-4 months long. The investigators will initiate surveys of Veterans who have survived their initial SARS-CoV-2 infection. The viral infection "index date" will be defined as date of each patient's first positive test.
Veterans Who Did Not Test Positive for COVID-19 (Comparator)
n=244 Participants
To support causal inference, the investigators will also sample Veterans without COVID who are matched to participants with COVID-19. In general, cases will be compared to comparators matched on risk of developing COVID infection during a given wave.
Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Score
18-month I/ADL Score
3.40 I/ADL Score
Standard Deviation 3.18
3.05 I/ADL Score
Standard Deviation 3.09
Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Score
24-month I/ADL Score
3.50 I/ADL Score
Standard Deviation 3.40
3.40 I/ADL Score
Standard Deviation 3.30
Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Score
30-month I/ADL Score
3.31 I/ADL Score
Standard Deviation 3.39
2.98 I/ADL Score
Standard Deviation 2.88
Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Score
36-month I/ADL Score
3.60 I/ADL Score
Standard Deviation 3.50
3.30 I/ADL Score
Standard Deviation 3.20

Adverse Events

Veterans Who Tested Positive for COVID-19 (Case)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Veterans Who Did Not Test Positive for COVID-19 (Comparator)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Project Manager

Center to Improve Veteran Involvement in Care (CIVIC), VA Portland Health Care System

Phone: 503-220-8262

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place