- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05441631
Can Intensive Insulin Therapy Improve Outcomes of COVID-19 Patients
Dysglycemia and COVID-19 Disease: A Reciprocal Relationship. Can Intensive Insulin Therapy Cut This Vicious Circle?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
All patients admitted to the quarantine department at Benha University hospital and quarantine hospitals all over the Qalyubia Governorate were eligible for evaluation for exclusion criteria. Taking on the precautions according to the instruction of the Ministry of Health on dealing with suspected or confirmed COVID patients and with the application of conditions of Infection Control Programs and considering the personal protective equipment, clinical, radiological, and laboratory evaluation were undertaken.
- COVID-19 disease severity grading Patients were categorized according to the guidelines of the National Institutes of Health (NIH) and patients with pre-symptomatic infection or critical disease severity were excluded, while patients with mild-to-severe disease severity grade were enrolled in the study: Mild disease was defined as the presence of any of the signs and symptoms of COVID-19 without shortness of breath, dyspnea, or abnormal chest imaging. The moderate disease was determined by the presence of evidence of lower respiratory disease during clinical assessment or imaging, but oxygen saturation (SpO2) was ≥94% on room air at sea level. Patients were diagnosed as having the severe disease if SpO2 was <94% on room air at sea level, a ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) <300 mm Hg, respiratory frequency >30 breaths/min, or lung infiltrates >50% (10).
- Diagnosis of hyperglycemia Stress hyperglycemia was defined according to the American Association of Clinical Endocrinologists and American Diabetes Association Consensus Statement on Inpatient Glycemic Control, as transient BG level at the time of admission >140 mg/dl that subsided on relief of stress and apprehension, but if BG persisted >140 mg/dl at 6-hr after admission it is persistent hyperglycemia and needs intervention (11). For diagnosis of hyperglycemia and determination of baseline BG level of diabetic patients blood samples were obtained at admission and 6-hr thereafter for non-diabetic and put in a tube containing sodium fluoride (2 mg sodium fluoride/ ml blood) to prevent glycolysis till estimation of BG levels using glucose oxidase method (12).
- COVID-GRAM Critical Illness Risk Score At the time of admission, the risk for progression to critical COVID-19 illness was evaluated by one of the authors and the determined risk remained uncovered till the end of the study for comparative purposes. The risk of progression to critical illness depended on the three outcomes defined by Liang et al. (13) as admission to the ICU, need for invasive mechanical ventilation (IMV), or death. The risk of progression to critical illness was determined qualitatively as low, medium, or high and quantitatively as risk percentage using the COVID-GRAM Critical Illness Risk (CG-CIR) Score that can be computed depending on clinical, radiological, and laboratory findings at the time of admission using an online calculator (14).
Patients' grouping
- Diabetic group: includes patients with definite DM and maintained on anti-diabetic therapy, either oral hypoglycemic or insulin therapy. Patients were divided according to the type of DM as T1D or T2D groups.
- Non-diabetic group: included patients who denied any history of DM or receiving antidiabetic therapy and were categorized as normoglycemic (NG) if their at admission random BG was <140 mg/dl or had stress hyperglycemia that disappeared at the 6-hr estimation of BG (NG Group), and hyperglycemic if their at admission BG level was >140 mg/dl and persisted at 6-hr estimation (HG Group).
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
El- Qalyobia
-
Banhā, El- Qalyobia, Egypt, 13511
- Banha University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Diabetic Non-diabetic Confirmed COVID-19 disease both by PCR diagnosis of viral RNA and by CT diagnosis of COVID-associated pneumonia.
Exclusion Criteria:
Patients younger than 18 years, patients admitted with critical illness requiring immediate admission to ICU, patients deceased before evaluation, patients who had autoimmune diseases or were maintained on immunosuppressive therapy, patients with chronic medical diseases other than DM, patients requiring surgical interference for emergency conditions, and patients who had cancer or were maintained anticancer therapy were excluded from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Intensive insulin therapy
|
|
Active Comparator: Conventional insulin therapy
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The relation between application intensive insulin therapy and patients' survival
Time Frame: 12 months
|
The relation between intensive insulin therapy and patients outcome regarding deuteration to Critical illness grade and mortality rate
|
12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- COVID-19
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Insulin
- Insulin, Globin Zinc
Other Study ID Numbers
- RC 1.6.2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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