Can Intensive Insulin Therapy Improve Outcomes of COVID-19 Patients

NCT05441631 | Completed Phase 1 FDA Drug

• 1 other identifier: RC 1.6.2020
• Study Type: interventional
• Target: 436
• Locations: 1 country
• Sites: 1

Brief 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 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

Conditions

COVID-19; Dysglycemia

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Study Arms (2)

Intensive insulin therapy

ACTIVE COMPARATOR

Drug: Insulin

Conventional insulin therapy

ACTIVE COMPARATOR

Drug: Subcutaneous Insulin

Interventions

Insulin DRUG

* 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)

Intensive insulin therapy

Subcutaneous Insulin DRUG

* Insulin dose was titrated according to the Blood glucose level * monitoring according to glucose in urine

Conventional insulin therapy

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetic
• Non-diabetic
• Confirmed COVID-19 disease both by PCR diagnosis of viral RNA and by CT diagnosis of COVID- associated pneumonia.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Banha University

Banhā, El- Qalyobia, 13511, Egypt

Location

MeSH Terms

Conditions

COVID-19

Interventions

Insulin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Internal Medicine

Study Record Dates

• First Submitted: June 18, 2022
• First Posted: July 1, 2022
• Study Start: April 1, 2020
• Primary Completion: July 15, 2020
• Study Completion: December 1, 2021
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)