COVID Clinical Trial
Official title:
Phase II Clinical Trial of Estradiol to Reduce Severity of COVID19 Infection in COVID19+ and Presumptive COVID19+ Patients
The purpose of this study is to find out if estrogen, a female sex hormone, given as a patch placed on skin of COVID19 positive or presumptive positive patients for 7 days can reduce the severity of COVID19 symptoms compared to regular care. This study has two study groups. One group will receive the study drug, a single-use Climara 25cm2 estrogen patch. The other group will receive standard of care. Participants will be asked questions about their symptoms for up 6 times in up to 45 days.
As the COVID19 pandemic has spread, it has been observed that adult men of all ages and older women are at higher risk of developing serious complications from infection with the virus. Animal model studies of SARS suggest that the age and sex difference in COVID19 symptom severity may be due to protective and acute actions of the female sex hormone estrogen. Animal and human studies support immune modulating effects of estrogen that are acute acting in viral infections and wound repair processes that may reduce the damaging effects of the virus on the lung and symptom severity. Our hypothesis is that a short 7 day course of estradiol delivered in a transdermal patch applied to the upper buttock in COVID19+ or presumptive positive patients will be safe and will reduce symptom severity in adult men and older women when given prior to intubation. COVID19+ and presumptive positive patients not requiring intubation will be enrolled to the study and randomized to receive an estrogen patch or standard of care. Patients will be followed up at day 1, 7, 14 and 28 for clinical symptoms and disease outcomes. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT04558125 -
Low-Dose Tenecteplase in Covid-19 Diagnosed With Pulmonary Embolism
|
Phase 4 | |
| Recruiting |
NCT04410510 -
P2Et Extract in the Symptomatic Treatment of Subjects With COVID-19
|
Phase 2/Phase 3 | |
| Active, not recruiting |
NCT04420676 -
Synbiotic Therapy of Gastrointestinal Symptoms During Covid-19 Infection
|
N/A | |
| Completed |
NCT04419025 -
Efficacy of N-Acetylcysteine (NAC) in Preventing COVID-19 From Progressing to Severe Disease
|
Phase 2 | |
| Completed |
NCT04395911 -
Safety and Efficacy of SCD in AKI or ARDS Patients Associated With COVID-19 Infections
|
N/A | |
| Completed |
NCT04425317 -
Detection of SARS-CoV-2 in Follicular Fluid and Cumulus-oocyte-complexes in COVID-19 Patients
|
N/A | |
| Withdrawn |
NCT04456426 -
Characteristics of Patients With COVID-19 in Meta State, Colombia
|
||
| Completed |
NCT04526769 -
Detecting SARS-CoV-2 in Tears
|
||
| Completed |
NCT04425720 -
Use of Remote Monitoring for COVID-19 Patient
|
N/A | |
| Suspended |
NCT04385771 -
Cytokine Adsorption in Patients With Severe COVID-19 Pneumonia Requiring Extracorporeal Membrane Oxygenation
|
N/A | |
| Completed |
NCT04419610 -
RAS and Coagulopathy in COVID19
|
Early Phase 1 | |
| Completed |
NCT04546581 -
Inpatient Treatment of COVID-19 With Anti-Coronavirus Immunoglobulin (ITAC)
|
Phase 3 | |
| Completed |
NCT04435327 -
Lung Damage Caused by SARS-CoV-2 Pneumonia (COVID-19)
|
||
| Terminated |
NCT04530448 -
Coronavirus Induced Acute Kidney Injury: Prevention Using Urine Alkalinization
|
Phase 4 | |
| Not yet recruiting |
NCT04524156 -
COVID-19 : Transcutaneous pO2 and pCO2 as Predictive Factors for Acute Respiratory Destress Syndrome in Patients Affected With SARS-Cov-2
|
N/A | |
| Completed |
NCT04441710 -
Caregiver Serological Monitoring Extended Secondarily to Patients With the SARS-CoV-2 Coronavirus
|
||
| Completed |
NCT04357834 -
WAVE. Wearable-based COVID-19 Markers for Prediction of Clinical Trajectories
|
||
| Not yet recruiting |
NCT04392427 -
New Antiviral Drugs for Treatment of COVID-19
|
Phase 3 | |
| Terminated |
NCT04614025 -
Open-label Multicenter Study to Evaluate the Efficacy of PLX-PAD for the Treatment of COVID-19
|
Phase 2 | |
| Completed |
NCT04402957 -
LSALT Peptide vs. Placebo to Prevent ARDS and Acute Kidney Injury in Patients Infected With SARS-CoV-2 (COVID-19)
|
Phase 2 |