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Can Intensive Insulin Therapy Improve Outcomes of COVID-19 Patients

NCT05441631 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 436

Last updated 2024-08-01

No results posted yet for this study

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

Interventions

DRUG

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

Subcutaneous Insulin

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

Sponsors & Collaborators

  • Benha University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-01
Primary Completion
2020-07-15
Completion
2021-12-01
FDA Drug
Yes

Countries

  • Egypt

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05441631 on ClinicalTrials.gov