Can Intensive Insulin Therapy Improve Outcomes of COVID-19 Patients

What Was Tested

This registered phase 1 trial tested Insulin (regular human).

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.

It had two arms (groups): Intensive insulin therapy (active comparator) and Conventional insulin therapy (active comparator).

The registry classes the interventions as drug.

More on the Plan

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. 1.

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.

Patients' grouping * Diabetic group: includes patients with definite DM and maintained on anti-diabetic therapy, either oral hypoglycemic or insulin therapy.

Who Took Part

The registry lists 436 actual participants took part.

It was open to people of any sex aged from 20 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Confirmed COVID-19 disease both by PCR diagnosis of viral RNA and by CT diagnosis of COVID- associated pneumonia.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: patients younger than 18 years,; patients admitted with critical illness requiring immediate admission to icu,; patients deceased before evaluation,.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

In this single-blind Insulin (regular human) study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2020-04-01 with completion listed for 2020-07-15.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The relation between application intensive insulin therapy and patients' survival (time frame: 12 months).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin (regular human) in 436 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.