Covid-19 Positivity Confirmed With PCR Positivity in the Nasopharyngeal SwabNCT04997928
PAI-1 Levels and Predicting Covid-19 Patients' Prognosis
An observational study of Covid-19 Positivity Confirmed With PCR Positivity in the Nasopharyngeal Swab and Symptomatic Covid -19 Positive Patients Who Require Hospitalization, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of our study is to understand the effects of Covid-19 disease on vascular inflammation and coagulation cascade, and secondarily, to investigate its utility in predicting disease prognosis by analyzing serum PAI-1 levels in patients with different severity. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid-19 Positivity Confirmed With PCR Positivity in the Nasopharyngeal Swab, Symptomatic Covid -19 Positive Patients Who Require Hospitalization, Patients Who Did Not Vaccinate Against Covid-19
- What is being tested?
- Serum PAI-1 alpha analysis.
- Type of treatment
- Vaccines
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jan 2021to 30 Sep 2021
- How long will I take part?
- 9 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study population: patients who are 20 years of age and older, having Covid-19 PCR positivity in the nasopharyngeal swab and showing symptoms of Covid-19 (fever, cough, dyspnea, joint pain, etc.) with or without involvement in lung imaging. A total of 80 volunteers will be enrolled in the trial whose age, gender, and BMI are planned to be matched.
Who may be able to join
- Patients who are 20 years of age and older, having Covid-19 PCR positivity in the nasopharyngeal swab and showing symptoms of Covid-19 (fever, cough, dyspnea, joint pain, etc.) with or without involvement in lung imaging.
- Patients may have hypertension disease and type II diabetes mellitus (occurring less than 5 years, diet and/or insulin-regulated).
- HbA1C levels of all participants (HbA1C < 6.4%) will be studied to confirm if any patient in the study or control groups has unregulated DM or undiagnosed overlooked DM. Diabetic patients with an HbA1C level above 6.4% will be excluded from the study.
- Enrolled patients have to have a diagnostic chest X-ray and/or HRCT. (Participants will be subjected to radiological classification and scoring according to lung involvement such as ground-glass opacity.)
Who cannot join
- Patients who are considered to have previous vascular endothelial damage due to secondary causes such as history of thrombosis, thrombophlebitis and/or thromboembolism,
- Presence of active cancer, history of chemotherapy, radiotherapy or bone marrow transplantation,
- Presence or history of autoimmune, connective tissue diseases, vasculitis (autoimmune thyroiditis, Crohn's, ulcerative colitis, SLE, Sjogren's disease, etc.),
- Familial inherited hereditary diseases (Hemophilia, Mediterranean anemia, FMF, Thalassemia major etc.)
- Patients with chronic renal failure and/or requiring dialysis,
- Presence of acquired/congenital immunodeficiency,
Show all 12Show fewer
- Patients who are receiving immunosuppressive or biologic drug therapy,
- Patients receiving treatment with a diagnosis of bronchial asthma,
- Type 1 or type 2 diabetes mellitus patients with HbA1C levels > 6.4%
- Patients with diabetes for more than 5 years or currently taking oral insulin-sensitizing drugs (biguanides; metformin)
- Patients using antithrombotic (Clopidogrel, low-dose aspirin, etc.) and anticoagulant (LMWH, Warfarin, etc.) agents due to comorbid disease at the time of diagnosis.
- Patients using ACE inhibitors such as lisinopril as an antihypertensive agent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
University of Health Sciences Turkey, Gulhane Research and Training Hospital
Ankara
Nazli ERCAN, MD
About this study
Official title: Predicting The Prognosis Of Covid-19 Patients With Circulating Inflammatory and Coagulation Markers
The primary aim of our study is to understand the effects of Covid-19 disease on vascular inflammation and coagulation cascade, and secondarily, to investigate its utility in predicting disease prognosis by analyzing serum PAI-1 levels in patients with different severity. The study is planned as a prospective, cross-sectional study that will include patients admitted to Covid-19 services between January 18, 2021, and August 30, 2021. A total of 80 volunteers will be enrolled in the trial whose age, gender, and BMI are planned to be matched.The study will be conducted on four groups. Group 1 (n=20; with mild symptoms), Group 2 (n=20; with moderate symptoms), Group 3 (n=20; with severe symptoms) and Group 4 (n=20; Control group).
All participants who accepted the study will have their sociodemographic data, medical history, and vital signs (respiratory rate, saturation, temperature, and blood pressure values) recorded at the start of the study. The pulmonologist in the study will also classify the patient group's chest X-ray and chest tomography findings and the thymus gland dimensions. After all four groups of patients have given their consent for the study, a sample of 5cc blood will be obtained once for the PAI-1 analysis.
Read the detailed description
The study is planned as a prospective, cross-sectional study that will include patients admitted to Covid-19 services between January 18, 2021, and August 30, 2021. A total of 80 volunteers will be enrolled in the trial whose age, gender, and BMI are planned to be matched. The study will be conducted on four groups.
Group 1 (n=20; with mild symptoms)
- Covid positive patients with mild symptoms who required to be hospitalized,
- Symptomatic (fever, cough, weakness, joint pain, etc.) new patients who apply to the Covid clinic for the first time,
- Patients with stable vital signs and/or SpO2 ≥92% in room air, no radiological signs of lung involvement or mild pneumonia,
- Patients who have not been started on steroid therapy and who have not yet received anticoagulant therapy.
Group 2 (n=20; with moderate symptoms)
- Patients who are positive for Covid 19 and admitted to the covid clinic for the first time;
- Radiologically moderate pneumonia findings and/or SpO2=88-92% in room air,
- Patients who have not been started antiviral, steroid, and anticoagulant treatment.
Group 3 (n=20; with severe symptoms)
- Patients who are currently hospitalized in the Covid clinic,
- Patients with radiological findings of severe pneumonia or ARDS and/or high FiO2 requirement due to respiratory failure.
- Patients of this group may have received antiviral, anticoagulant, and/or steroid and/or biologic agent treatment.
Group 4 (n=20; Control group)
- The control group will be composed of healthy adult individuals applying to adult allergy outpatient clinics on a voluntary basis.
- Patients who have not been previously diagnosed with Covid-19 and have not vaccinated against Covid-19,
- The control patients will be matched with the study groups according to age, gender, and BMI.
All participants who accepted the study will have their sociodemographic data, medical history, and vital signs (respiratory rate, saturation, temperature, and blood pressure values) recorded at the start of the study. The pulmonologist in the study will also classify the patient group's chest X-ray and chest tomography findings, as well as the thymus gland dimensions. After all four groups of patients have given their consent for the study, a sample of 5cc blood will be obtained once for the PAI-1analysis. The sample will be centrifuged for around 5 minutes at 3000 rpm before being frozen at -70 degrees. The blood sample will be dissolved under proper conditions after a sufficient number of participants has been reached. The researchers will provide the ELISA kits for the study, and laboratory services will be purchased from outside the hospital. Due to Covid-19 disease, white blood cell, neutrophil, lymphocyte, and platelet counts, liver enzymes (AST, ALT, LDH), sodium, total protein, albumin, aPTT, PTZ, INR, D-Dimer, and fibrinogen levels will be recorded in the patient case report form, as well as CRP, IL-6, and ferritin levels, which are routinely requested from patients during their hospitalization. No treatment other than the treatments specified in the Covid-19 guidelines of the Ministry of Health will never be applied to the patients.
- Conditions
- Covid-19 Positivity Confirmed With PCR Positivity in the Nasopharyngeal Swab, Symptomatic Covid -19 Positive Patients Who Require Hospitalization, Patients Who Did Not Vaccinate Against Covid-19, Patients Among 20 to 90 Years of Age, Healthy Control Patients of the Same Age
- Being tested
- Serum PAI-1 alpha analysis.
- Keywords
- Covid-19, Polymerase Chain Reaction, Plasminogen activator inhibitor 1, Pneumonia
- Medical subject headings
- COVID-19, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum PAI-1 alpha analysis.Other
After all four groups of patients have given their consent for the study, a sample of 5cc blood will be obtained once for the PAI-1 analysis.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (n=20; with mild symptoms) | Group 1 (n=20; with mild symptoms)
* Covid positive patients with mild symptoms who required to be hospitalized,
* Symptomatic (fever, cough, weakness, joint pain, etc.) new patients who apply to the Covid clinic for the first time,
* Patients with stable vital signs and/or SpO2 ≥92% in room air, no radiological signs of lung involvement or mild pneumonia,
* Patients who have not been started on steroid therapy and who have not yet received anticoagulant therapy. Receives: Other: Serum PAI-1 alpha analysis. | |
| Group 2 (n=20; with moderate symptoms) | Group 2 (n=20; with moderate symptoms)
* Patients who are positive for Covid 19 and admitted to the covid clinic for the first time;
* Radiologically moderate pneumonia findings and/or SpO2=88-92% in room air,
* Patients who have not been started antiviral, steroid, and anticoagulant treatment. Receives: Other: Serum PAI-1 alpha analysis. | |
| Group 3 (n=20; with severe symptoms) | Group 3 (n=20; with severe symptoms)
* Patients who are currently hospitalized in the Covid clinic,
* Patients with radiological findings of severe pneumonia or ARDS and/or high FiO2 requirement due to respiratory failure.
* Patients of this group may have received antiviral, anticoagulant, and/or steroid and/or biologic agent treatment. Receives: Other: Serum PAI-1 alpha analysis. | |
| Group 4 (n=20; Control group) | Group 4 (n=20; Control group)
* The control group will be composed of healthy adult individuals applying to adult allergy outpatient clinics on a voluntary basis.
* Patients who have not been previously diagnosed with Covid-19 and have not vaccinated against Covid-19,
* The control patients will be matched with the study groups according to age, gender, and BMI. Receives: Other: Serum PAI-1 alpha analysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum PAI-1 levels of Covid-19 patients
To understand the effects of Covid-19 disease on vascular inflammation and coagulation cascade.
Measured: Blood sample collection is limited to up to 32 weeks and laboratory studies will be completed up to one week.
Secondary outcomes (1)
Serum PAI-1 levels of Covid-19 patients
To investigate PAI-1 utility in predicting disease prognosis.
Measured: Up to 32 weeks for blood sample collection and up to one week for laboratory analysis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start18 Jan 2021
- Primary completion30 Aug 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid-19 Positivity Confirmed With PCR Positivity in the Nasopharyngeal SwabStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazlı ERCAN, Saglik Bilimleri Universitesi
- Investigators
- Ozgür Kartal, MD, Study chair, University of Health Sciences Turkey, Gulhane Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997928
- Sponsor's protocol ID
- COVID19PAI-1
- Status last verified
- Aug 2021
- First submitted
- 5 Aug 2021
- Last updated
- 10 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kwaan HC. Coronavirus Disease 2019: The Role of the Fibrinolytic System from Transmission to Organ Injury and Sequelae. Semin Thromb Hemost. 2020 Oct;46(7):841-844. doi: 10.1055/s-0040-1709996. Epub 2020 May 9. No abstract available.
PubMed 32386428
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting The Prognosis Of Covid-19 Patients With Circulating Inflammatory and Coagulation Markers
- ClinicalTrials.gov ID
- NCT04997928
- Acronym / sponsor ID
- COVID19PAI-1
- Conditions
- Covid-19 Positivity Confirmed With PCR Positivity in the Nasopharyngeal Swab, Symptomatic Covid -19 Positive Patients Who Require Hospitalization, Patients Who Did Not Vaccinate Against Covid-19, Patients Among 20 to 90 Years of Age, Healthy Control Patients of the Same Age
- Keywords
- Covid-19, Polymerase Chain Reaction, Plasminogen activator inhibitor 1, Pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 10 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of our study is to understand the effects of Covid-19 disease on vascular inflammation and coagulation cascade, and secondarily, to investigate its utility in predicting disease prognosis by analyzing serum PAI-1 levels in patients with different severity. The study is planned as a prospective, cross-sectional study that will include patients admitted to Covid-19 services between January 18, 2021, and August 30, 2021. A total of 80 volunteers will be enrolled in the trial whose age, gender, and BMI are planned to be matched.The study will be conducted on four groups. Group 1 (n=20; with mild symptoms), Group 2 (n=20; with moderate symptoms), Group 3 (n=20; with severe symptoms) and Group 4 (n=20; Control group).
All participants who accepted the study will have their sociodemographic data, medical history, and vital signs (respiratory rate, saturation, temperature, and blood pressure values) recorded at the start of the study. The pulmonologist in the study will also classify the patient group's chest X-ray and chest tomography findings and the thymus gland dimensions. After all four groups of patients have given their consent for the study, a sample of 5cc blood will be obtained once for the PAI-1 analysis.
Detailed description
The study is planned as a prospective, cross-sectional study that will include patients admitted to Covid-19 services between January 18, 2021, and August 30, 2021. A total of 80 volunteers will be enrolled in the trial whose age, gender, and BMI are planned to be matched. The study will be conducted on four groups.
Group 1 (n=20; with mild symptoms)
- Covid positive patients with mild symptoms who required to be hospitalized,
- Symptomatic (fever, cough, weakness, joint pain, etc.) new patients who apply to the Covid clinic for the first time,
- Patients with stable vital signs and/or SpO2 ≥92% in room air, no radiological signs of lung involvement or mild pneumonia,
- Patients who have not been started on steroid therapy and who have not yet received anticoagulant therapy.
Group 2 (n=20; with moderate symptoms)
- Patients who are positive for Covid 19 and admitted to the covid clinic for the first time;
- Radiologically moderate pneumonia findings and/or SpO2=88-92% in room air,
- Patients who have not been started antiviral, steroid, and anticoagulant treatment.
Group 3 (n=20; with severe symptoms)
- Patients who are currently hospitalized in the Covid clinic,
- Patients with radiological findings of severe pneumonia or ARDS and/or high FiO2 requirement due to respiratory failure.
- Patients of this group may have received antiviral, anticoagulant, and/or steroid and/or biologic agent treatment.
Group 4 (n=20; Control group)
- The control group will be composed of healthy adult individuals applying to adult allergy outpatient clinics on a voluntary basis.
- Patients who have not been previously diagnosed with Covid-19 and have not vaccinated against Covid-19,
- The control patients will be matched with the study groups according to age, gender, and BMI.
All participants who accepted the study will have their sociodemographic data, medical history, and vital signs (respiratory rate, saturation, temperature, and blood pressure values) recorded at the start of the study. The pulmonologist in the study will also classify the patient group's chest X-ray and chest tomography findings, as well as the thymus gland dimensions. After all four groups of patients have given their consent for the study, a sample of 5cc blood will be obtained once for the PAI-1analysis. The sample will be centrifuged for around 5 minutes at 3000 rpm before being frozen at -70 degrees. The blood sample will be dissolved under proper conditions after a sufficient number of participants has been reached. The researchers will provide the ELISA kits for the study, and laboratory services will be purchased from outside the hospital. Due to Covid-19 disease, white blood cell, neutrophil, lymphocyte, and platelet counts, liver enzymes (AST, ALT, LDH), sodium, total protein, albumin, aPTT, PTZ, INR, D-Dimer, and fibrinogen levels will be recorded in the patient case report form, as well as CRP, IL-6, and ferritin levels, which are routinely requested from patients during their hospitalization. No treatment other than the treatments specified in the Covid-19 guidelines of the Ministry of Health will never be applied to the patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 (n=20; with mild symptoms) | – | Other: Serum PAI-1 alpha analysis.Group 1 (n=20; with mild symptoms) * Covid positive patients with mild symptoms who required to be hospitalized, * Symptomatic (fever, cough, weakness, joint pain, etc.) new patients who apply to the Covid clinic for the first time, * Patients with stable vital signs and/or SpO2 ≥92% in room air, no radiological signs of lung involvement or mild pneumonia, * Patients who have not been started on steroid therapy and who have not yet received anticoagulant therapy. |
| Group 2 (n=20; with moderate symptoms) | – | Other: Serum PAI-1 alpha analysis.Group 2 (n=20; with moderate symptoms) * Patients who are positive for Covid 19 and admitted to the covid clinic for the first time; * Radiologically moderate pneumonia findings and/or SpO2=88-92% in room air, * Patients who have not been started antiviral, steroid, and anticoagulant treatment. |
| Group 3 (n=20; with severe symptoms) | – | Other: Serum PAI-1 alpha analysis.Group 3 (n=20; with severe symptoms) * Patients who are currently hospitalized in the Covid clinic, * Patients with radiological findings of severe pneumonia or ARDS and/or high FiO2 requirement due to respiratory failure. * Patients of this group may have received antiviral, anticoagulant, and/or steroid and/or biologic agent treatment. |
| Group 4 (n=20; Control group) | – | Other: Serum PAI-1 alpha analysis.Group 4 (n=20; Control group) * The control group will be composed of healthy adult individuals applying to adult allergy outpatient clinics on a voluntary basis. * Patients who have not been previously diagnosed with Covid-19 and have not vaccinated against Covid-19, * The control patients will be matched with the study groups according to age, gender, and BMI. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population: patients who are 20 years of age and older, having Covid-19 PCR positivity in the nasopharyngeal swab and showing symptoms of Covid-19 (fever, cough, dyspnea, joint pain, etc.) with or without involvement in lung imaging. A total of 80 volunteers will be enrolled in the trial whose age, gender, and BMI are planned to be matched.
Key inclusion criteria (4 listed)
- Patients who are 20 years of age and older, having Covid-19 PCR positivity in the nasopharyngeal swab and showing symptoms of Covid-19 (fever, cough, dyspnea, joint pain, etc.) with or without involvement in lung imaging.
- Patients may have hypertension disease and type II diabetes mellitus (occurring less than 5 years, diet and/or insulin-regulated).
- HbA1C levels of all participants (HbA1C < 6.4%) will be studied to confirm if any patient in the study or control groups has unregulated DM or undiagnosed overlooked DM. Diabetic patients with an HbA1C level above 6.4% will be excluded from the study.
- Enrolled patients have to have a diagnostic chest X-ray and/or HRCT. (Participants will be subjected to radiological classification and scoring according to lung involvement such as ground-glass opacity.)
Key exclusion criteria (12 listed)
- Patients who are considered to have previous vascular endothelial damage due to secondary causes such as history of thrombosis, thrombophlebitis and/or thromboembolism,
- Presence of active cancer, history of chemotherapy, radiotherapy or bone marrow transplantation,
- Presence or history of autoimmune, connective tissue diseases, vasculitis (autoimmune thyroiditis, Crohn's, ulcerative colitis, SLE, Sjogren's disease, etc.),
- Familial inherited hereditary diseases (Hemophilia, Mediterranean anemia, FMF, Thalassemia major etc.)
- Patients with chronic renal failure and/or requiring dialysis,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum PAI-1 alpha analysis.After all four groups of patients have given their consent for the study, a sample of 5cc blood will be obtained once for the PAI-1 analysis. | Other | Group 1 (n=20; with mild symptoms), Group 2 (n=20; with moderate symptoms), Group 3 (n=20; with severe symptoms), Group 4 (n=20; Control group) |
Primary outcome
Serum PAI-1 levels of Covid-19 patients
Time frame: Blood sample collection is limited to up to 32 weeks and laboratory studies will be completed up to one week.
To understand the effects of Covid-19 disease on vascular inflammation and coagulation cascade.
1 secondary outcome
Serum PAI-1 levels of Covid-19 patients
Time frame: Up to 32 weeks for blood sample collection and up to one week for laboratory analysis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Results publication: PubMed 32386428Kwaan HC. Coronavirus Disease 2019: The Role of the Fibrinolytic System from Transmission to Organ Injury and Sequelae. Semin Thromb Hemost. 2020 Oct;46(7):841-844. doi: 10.1055/s-0040-1709996. Epub 2020 May 9. No abstract available.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ozgür Kartal, MD study chair
University of Health Sciences Turkey, Gulhane Research and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid-19 Positivity Confirmed With PCR Positivity in the Nasopharyngeal Swab and Symptomatic Covid -19 Positive Patients Who Require Hospitalization, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nazli Ercan, MD (+905319957255, drnazliercan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum PAI-1 levels of Covid-19 patients (time frame: Blood sample collection is limited to up to 32 weeks and laboratory studies will be completed up to one week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04997928, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2021.