Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05175846 |
| Other study ID # |
001 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2022 |
| Est. completion date |
June 30, 2023 |
Study information
| Verified date |
January 2022 |
| Source |
Trinitas Global, LLC |
| Contact |
Lynn G Project Manager |
| Phone |
206 890 2710 |
| Email |
lynngallen[@]live.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Observational Study of the Association of Immunological and Inflammatory Biomarkers in
COVID-19 Naïve and Infected Participants and Severity of Disease. Thirty naive and 30 COVID
positive participants will have a blood sample taken after informed consent and be assessed
for COVID symptoms according to WHO classification. Participants will be followed monthly for
6 months. At each contact, participants will be assessed for COVID symptoms and progress
since the previous visit.
Description:
This is an observational study of participants who are being or have been tested for
COVID-19. Participants with or without COVID-19 will be entered into one of two groups for
Stage 1 and one of three groups for Stage 2.
Stage 1:
- Group 1: Participants whose COVID-19 test is negative and who do not have symptoms of
COVID-19 disease.
- Group 2: Participants whose COVID-19 test is positive and who have Severe or Critical
symptoms of COVID-19 disease.
Stage 2:
- Group 1: Participants whose COVID-19 test is negative and who do not have symptoms of
COVID-19 disease.
- Group 2: Participants whose COVID-19 test is positive and who have Mild or Moderate
symptoms of COVID-19 disease.
- Group 3: Participants whose COVID-19 test is positive and who have Severe or Critical
symptoms of COVID-19 disease.
During Stage 1, Group 1 participants will be matched to Group 2 subjects as follows: Age:
18-64 and >65; Race: Caucasian, Latino, African American, other; Sex: Male or Female Each
participant will be assigned a study number. The study case report form (CRF) will record the
participants initials, age and study number. Participants will have blood drawn for
biomarkers. All samples will be identified using the participants age and study number. Blood
volume will be approximately ten milliliters to yield at least four 1 ml serum aliquots.
Serum will be frozen at -80ºF and stored. Batch shipments of the serum will occur during the
study and sent to AccessDx Laboratory in Houston TX. Laboratory procedures for AccessDx are
presented in Appendices B and C. AccessDx will perform the following biomarker tests on the
serum: Interleukins 1B, 6, 8,10, 22; CRP; Ferritin; Interferon-ꝩ; MIP 1α and 1β; TNF; VEGF A,
B, C.
Participants will be followed for up to 6 months and have monthly calls from the study staff.
As much as possible, the participant will be contacted by the same study member at each
follow-up visit. If agreed with the participant, information about the participants status
may be collected on email or text. Participants will be asked specific questions and their
responses recorded on a paper CRF. At enrollment and at each follow-up call, the
participant's severity of COVID-19 disease will be categorized based on WHO Interim guidance
27 May 2020 as follows:
- Mild cases are marked by the onset of symptoms such as fever, cough, fatigue, shortness
of breath, headache, diarrhea, and so forth, without evidence of viral pneumonia or
hypoxia.
- Moderate cases include clinical signs of pneumonia (fever, cough, dyspnea, fast
breathing) but no signs of severe pneumonia, including SpO2 ≥ 90% on room air.
- Severe cases demonstrate clinical signs of pneumonia (fever, cough, dyspnea, fast
breathing) plus one of the following: respiratory rate > 30 breaths/min; severe
respiratory distress; or SpO2 < 90% on room air.
- Critical cases present symptoms such as acute respiratory distress syndrome (ARDS),
sepsis and/or septic shock A participant's engagement in the study will be approximately
6 months. Recruitment is expected to last 6 months. It is expected that the total study
for Stage 1 will be one year. The duration of Stage 2 will not be determined until
results from Stage 1 are available. The number of investigator sites for Stage 1 is
expected to be up to 3 and for Stage 2, up to 50.
