Hormonal Intervention for the Treatment in Veterans With COVID-19 Requiring Hospitalization

What Was Tested

The trial (phase 2) is built around Degarelix.

It had two arms (groups): Placebo + BSC (placebo comparator) and Degarelix + BSC (experimental).

The registry classes the interventions as drug and other.

More on the Plan

A novel coronavirus, now termed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), arose late in 2019.

The first confirmed cases occurred in December in Wuhan, Hubei province, China.

It now infects people on six continents, spreading person to person.

The World Health Organization (WHO) classified it as a global pandemic on March 11, 2020.

Who Took Part

96 actual participants took part.

It was open to men only aged from 18 years up to 85 years.

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

Examples of who could join: Male Veterans admitted to a VA hospital. Age \> 18. Hospitalized on an acute care ward with a diagnosis of COVID-19 contributing to hospitalization. Positive RT-PCR assay for SARS-CoV-2 on a nasopharyngeal swab sample. Severity of illness of level 3, 4 or 5 on the influenza severity scale (see Appendix A) at the time of randomization.

The full record lists 6 inclusion and 17 exclusion criteria; among the exclusions: history of severe hypersensitivity to degarelix or any component of their respective formulation; planned discharge within 24 hours of treatment initiation; myocardial infarction in the past 6 months, severe or unstable angina, or new york heart association (nyha) class iii or iv heart disease.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Degarelix and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Degarelix.

Those kept unaware of assignments: participant and investigator.

It started in 2020-07-06 with completion listed for 2021-06-08.

It ran at 14 sites in United States (14).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Composite of Mortality, Ongoing Need for Hospitalization, or Mechanical Ventilation at Day 15 (time frame: 15 days).

It also tracked 7 secondary outcomes, for example Inpatient Mortality, Duration of Hospitalization, Duration of Intubation, Time to Normalization of Temperature, Maximum Severity of COVID19 Illness and Composite of Mortality, Ongoing Need for Hospitalization, or Mechanical Ventilation at Day 30.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Degarelix in 96 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Degarelix compound page, all human trials.