NCT05774405

Brief Summary

The goal of this randomized placebo-controlled study is to investigate the short-term effects of transdermal estrogen therapy on postmenopausal women with COVID-19 disease. The main question\[s\] it aims to answer are:

  • the clinical outcomes with adding estrogen treatment to conventional therapy of Covid-19 disease
  • the biochemical outcomes with adding estrogen treatment to conventional therapy of Covid-19 disease All participants received favipiravir for a week according to the national guidelines published by the Health Ministry of Turkish Republic at that time. As an intervention, transdermal estradiol patch (7.8 mg patch/week) was applied for 14 days on the upper buttock of the patients in experimental arm. As a placebo, hydrogel patch (adhesive hydrogel patch/week) was applied to the female patients for 14 days. Researchers compared experimental and control groups to see if the impact of adding estrogen on the clinical course of Covid-19 disease

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,169

participants targeted

Target at P75+ for phase_2 covid19

Timeline
Completed

Started Jul 2020

Typical duration for phase_2 covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 17, 2023

Completed
Last Updated

March 27, 2023

Status Verified

March 1, 2023

Enrollment Period

1.1 years

First QC Date

March 15, 2023

Last Update Submit

March 23, 2023

Conditions

COVID-19Hormone Replacement Therapy

Keywords

Covid-19hormone replacement therapy

Outcome Measures

Primary Outcomes (6)

  • Evidence of disease progression for mild cases

    Proportion of patients who are hospitalised in 15 days

    15 days

  • Evidence of disease progression for moderate and severe cases

    Proportion of patients who required mechanical ventilation or died within 15 days

    15 days

  • Kidney function tests

    change of urea(mg/dL), creatinine(mg/dL) and uric acid (mg/dL) levels with estrogen and hydrogel patch application

    15 days

  • Platelet

    change of platelets in total blood count (\*10\^3/μL) with estrogen and hydrogel patch application

    15 days

  • Markers of coagulation

    change of fibrinogen (mg/dL) and D-dimer (mg/L) with estrogen and hydrogel patch application

    15 days

  • Marker of inflammation

    change of C-reactive protein (mg/L) levels within 15 days

    15 days

Secondary Outcomes (3)

  • serum E2 levels

    15 days

  • rate of death

    15 days

  • rate of complications

    15 days

Study Arms (2)

Experimental

EXPERIMENTAL

All patients were treated with favipiravir for a week. At the same time, the patients in this arm received Estradiol patch (Climara 7.8 mg patch/week, Bayer, Germany) for 14 days.

Drug: Climara 0.1Mg/24Hr Transdermal System

Placebo

PLACEBO COMPARATOR

All patients were treated with favipiravir for a week. At the same time, the patients in this arm received Hydrogel patch (Adhesive Hydrogel patch/week, Rebul Pharmacy, Turkey) for 14 days.

Other: Hydrogel patch

Interventions

Climara 0.1Mg/24Hr Transdermal SystemDRUG

Transdermal estradiol patch is used.

Experimental
Hydrogel patchOTHER

Adhesive Hydrogel patch

Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patients diagnosed with Covid-19 disease
  • Postmenopausal women (who had 12 months of amenorrhea after their final menstrual period)
  • Positive reverse transcription-polymerase chain reaction (RT-PCR) test given with nasal and oral swabs

You may not qualify if:

  • Negative RT-PCR test
  • Female patients at reproductive stage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, 34098, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19

Interventions

Estradiol

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Cemal Tamer Erel, Prof

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 15, 2023

First Posted

March 17, 2023

Study Start

July 1, 2020

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

March 27, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)