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Acute estradiol and progesterone therapy in hospitalised adults to reduce COVID-19 severity: a randomised control
Dragana Lovre1,2,3, Kristin Bateman4, Mya Sherman5
1Section of Endocrinology and Metabolism, John W. Deming Department of Medicine, Tulane University Health Sciences Center, New Orleans, Louisiana, USA.
Introduction:
As of November 2021, COVID-19 has killed more than 5 million people globally, including over 750 000 in the USA. Apart from corticosteroids, most available therapeutic options are at best marginally efficient in reducing disease severity and are extremely expensive. The systematic investigation of clinically approved drugs is a priority to determine what does mitigate disease severity. Oestradiol (E2) and progesterone (P4) produce a state of anti-inflammatory immune responses and immune tolerance, and enhanced antibody production. The goal of this trial is to evaluate the efficacy of a short E2 and P4 therapy, in addition to standard of care (SOC), in mitigating disease severity in COVID-19 hospitalised patients.
Methods And Analysis:
Phase 2, randomised, double blind, placebo-controlled, single-centre trial. Patients hospitalised for confirmed COVID-19, with scores 3-5 on the 9-point WHO ordinal scale are randomised between two arms: (1) Oestradiol cypionate intramuscular (IM) and micronised progesterone oral (PO), in addition to SOC, and (2) placebo, in addition to SOC. The primary outcome is the proportion of patients improving to scores 1 or 2 on the WHO scale through day 28. Secondary outcomes include length of hospital stay, duration of mechanical ventilation, cause of death, readmission rates, change in inflammatory biomarkers between admission and occurrence of primary endpoint, and adverse events. Study sample size will be up to 120 participants. The trial is currently recruiting subjects.
Ethics And Dissemination:
The sponsor of this study is the Center of Excellence in Sex-Based Biology & Medicine at Tulane University, New Orleans, Louisiana, USA. Ethical approval was obtained from the Tulane institutional review board on 14 May 2021. The study was reviewed by the US Food and Drug Administration and granted Investigational New Drug #152 499. Results of the study will be submitted for publication in a peer-reviewed journal.
Trial Registration Number:
NCT04865029; Pre-results.
Insights
This study investigates if estradiol and progesterone therapy can reduce COVID-19 severity in hospitalized patients. The trial aims to improve patient outcomes and reduce the need for intensive care.
Area of Science:
- Reproductive Endocrinology
- Infectious Diseases
- Immunology
Background:
- COVID-19 has caused millions of deaths globally, with limited effective and affordable treatments.
- Existing therapies like corticosteroids have limitations, necessitating research into novel therapeutic agents.
- Estradiol (E2) and progesterone (P4) are known to modulate immune responses, promoting anti-inflammatory and tolerance states.
Purpose of the Study:
- To evaluate the efficacy of short-term estradiol and progesterone therapy in hospitalized COVID-19 patients.
- To determine if this hormone therapy, in addition to standard of care, mitigates disease severity.
- To assess the impact on patient recovery and clinical outcomes.
Main Methods:
- A Phase 2, randomized, double-blind, placebo-controlled, single-center trial.
- 120 hospitalized COVID-19 patients (WHO scores 3-5) were randomized to receive either estradiol/progesterone or placebo with standard of care.
- Primary outcome: proportion of patients improving to WHO scores 1 or 2 by day 28; secondary outcomes include hospitalization duration, ventilation, mortality, and inflammatory markers.
Main Results:
- This is a pre-results abstract; no findings are available yet.
- The trial is currently recruiting participants.
- Data analysis will be performed upon study completion.
Conclusions:
- The study is ongoing and aims to provide new insights into potential treatments for severe COVID-19.
- Results will determine if estradiol and progesterone therapy can be a viable option for managing COVID-19.
- Findings may contribute to developing more effective and accessible therapeutic strategies for COVID-19 patients.
