COVID-19Phase 1NCT05441631
Can Intensive Insulin Therapy Improve Outcomes of COVID-19 Patients
A Phase 1 study testing Insulin and Subcutaneous Insulin in people with COVID-19 and Dysglycemia, run by Benha University at 1 site in Egypt.
Trial summary
Evaluation of the reciprocal relation between hyperglycemia/diabetes mellitus (HG/DM) and COVID-19 disease and the effect of mode of insulin therapy; intensive (IIT) or conventional (CIT) on patients' outcomes All patients admitted to the quarantine hospitals with mild-severe COVID disease were evaluated using the… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- COVID-19, Dysglycemia
- What is being tested?
- Insulin and Subcutaneous Insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 436 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2020to 1 Dec 2021
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetic
- Non-diabetic
- Confirmed COVID-19 disease both by PCR diagnosis of viral RNA and by CT diagnosis of COVID- associated pneumonia.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dysglycemia and COVID-19 Disease: A Reciprocal Relationship. Can Intensive Insulin Therapy Cut This Vicious Circle?
Evaluation of the reciprocal relation between hyperglycemia/diabetes mellitus (HG/DM) and COVID-19 disease and the effect of mode of insulin therapy; intensive (IIT) or conventional (CIT) on patients' outcomes All patients admitted to the quarantine hospitals with mild-severe COVID disease were evaluated using the COVID-GRAM Critical Illness Risk Score and gave blood samples for estimation of random blood glucose. Diabetic patients and non-diabetic patients with persistent HG were randomly divided according to mode of IT. Patients who were free HG were included as control normoglycemic (NG) patients. Study outcomes included the incidence of progress to critical illness and mortality rate (MR), and the effect of IT on such outcomes
Read the 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).
- Conditions
- COVID-19, Dysglycemia
- Being tested
- Insulin, Subcutaneous Insulin
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
- Preparation: 50 IU of rapidly acting insulin in 50 ml of 0.9% saline solution was delivered through a 50-ml syringe-driven pump.
- Monitoring: The insulin dose was adjusted to whole-blood glucose levels using glucometer every hour and insulin infusion was continued till BG level (Targeted level) was 80-110 mg, and then BG levels were estimated four-hourly
- Insulin dose was titrated according to the Leuven titration protocol (15)
Subcutaneous InsulinDrug
- Insulin dose was titrated according to the Blood glucose level
- monitoring according to glucose in urine
| Study group | Role | What they receive |
|---|---|---|
| Intensive insulin therapy | Active comparator | Not described Receives: Drug: Insulin |
| Conventional insulin therapy | Active comparator | Not described Receives: Drug: Subcutaneous Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relation between application intensive insulin therapy and patients' survival
The relation between intensive insulin therapy and patients outcome regarding deuteration to Critical illness grade and mortality rate
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start1 Apr 2020
- Primary completion15 Jul 2020
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Benha UniversityThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 436 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr M. El Hammady, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441631
- Sponsor's protocol ID
- RC 1.6.2020
- Status last verified
- Jul 2024
- First submitted
- 18 Jun 2022
- Last updated
- 1 Aug 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dysglycemia and COVID-19 Disease: A Reciprocal Relationship. Can Intensive Insulin Therapy Cut This Vicious Circle?
- ClinicalTrials.gov ID
- NCT05441631
- Acronym / sponsor ID
- RC 1.6.2020
- Conditions
- COVID-19, Dysglycemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 436 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 1 Jul 2022 (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.
Evaluation of the reciprocal relation between hyperglycemia/diabetes mellitus (HG/DM) and COVID-19 disease and the effect of mode of insulin therapy; intensive (IIT) or conventional (CIT) on patients' outcomes All patients admitted to the quarantine hospitals with mild-severe COVID disease were evaluated using the COVID-GRAM Critical Illness Risk Score and gave blood samples for estimation of random blood glucose. Diabetic patients and non-diabetic patients with persistent HG were randomly divided according to mode of IT. Patients who were free HG were included as control normoglycemic (NG) patients. Study outcomes included the incidence of progress to critical illness and mortality rate (MR), and the effect of IT on such outcomes
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive insulin therapy | Active comparator | Drug: Insulin |
| Conventional insulin therapy | Active comparator | Drug: Subcutaneous Insulin |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diabetic
- Non-diabetic
- Confirmed COVID-19 disease both by PCR diagnosis of viral RNA and by CT diagnosis of COVID- associated pneumonia.
Key exclusion criteria (7 listed)
- 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,
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 |
|---|---|---|
| Insulin* Preparation: 50 IU of rapidly acting insulin in 50 ml of 0.9% saline solution was delivered through a 50-ml syringe-driven pump. * Monitoring: The insulin dose was adjusted to whole-blood glucose levels using glucometer every hour and insulin infusion was continued till BG level (Targeted level) was 80-110 mg, and then BG levels were estimated four-hourly * Insulin dose was titrated according to the Leuven titration protocol (15) | Drug | Intensive insulin therapy |
| Subcutaneous Insulin* Insulin dose was titrated according to the Blood glucose level * monitoring according to glucose in urine | Drug | Conventional insulin therapy |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Insulin and Subcutaneous Insulin in people with COVID-19 and Dysglycemia, run by Benha University at 1 site in Egypt.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 1 Aug 2024. 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 Egypt. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relation between application intensive insulin therapy and patients' survival (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2024.