Estradiol and Progesterone in Hospitalized COVID-19 Patients
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04865029 |
Recruitment Status :
Recruiting
First Posted : April 29, 2021
Last Update Posted : July 23, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Covid19 | Other: Placebo injection and placebo pill Drug: Estradiol Cypionate 5 MG/ML Drug: Progesterone 200 MG Oral Capsule | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Randomized, placebo-controlled |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | Double-blinded clinical trial |
Primary Purpose: | Treatment |
Official Title: | Acute Estradiol and Progesterone Therapy in Hospitalized Adults to Reduce Coronavirus Disease (COVID-19) Severity: A Randomized Control Trial |
Actual Study Start Date : | July 22, 2021 |
Estimated Primary Completion Date : | May 2022 |
Estimated Study Completion Date : | May 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Treatment Arm
Standard of Care along with Estradiol Cypionate 5mg intramuscular injection at admission and Progesterone 200mg by mouth daily for 5 days starting at admission.
|
Drug: Estradiol Cypionate 5 MG/ML
Standard of Care along with Estradiol Cypionate 5mg intramuscular injection at admission. Drug: Progesterone 200 MG Oral Capsule Standard of Care along with Progesterone 200mg by mouth daily for 5 days starting at admission. |
Control Arm
Standard of Care along with placebo injection and placebo pill Standard of Care consistent with the National Institutes of Health (NIH) COVID-19 Treatment Guidelines |
Other: Placebo injection and placebo pill
Standard of Care consistent with the National Institutes of Health (NIH) COVID-19 Treatment Guidelines |
- The proportion of patients who achieve scores 1 or 2 on the 9-point World Health Organization (WHO) ordinal scale through day 28. [ Time Frame: Baseline to Day 28 ]
The proportion will be calculated based on WHO ordinal scale for clinical improvement. The scale is from 0 to 8, with a higher score indicating worse clinical status.
- Uninfected: No clinical or virological evidence of infection 0
- Ambulatory: No limitation of activities 1 Limitation of activities 2
- Hospitalized Mild Disease Hospitalized, no oxygen therapy 3 Oxygen by mask or nasal prongs 4
- Hospitalized Severe Disease Non-invasive ventilation or high flow oxygen 5 Intubation and mechanical ventilation 6 Ventilation + additional organ support - 7 pressors, Renal Replacement Therapy (RRT), Extracorporeal Membrane Oxygenation (ECMO)
- Dead Death 8
- Length of hospital stay [ Time Frame: Day 14, Day 28, Day 60 ]The investigators will review patients' medical records on day 14 and day 28. Then, the investigators will call patients on day 60. This will be done to determine the efficiency of treatment on length of hospital stay.
- Readmission [ Time Frame: Day 14, Day 28, Day 60 ]The investigators will review patients' medical records on day 14 and day 28. Then, the investigators will call patients on day 60. This will be done to determine the readmission rates.
- Duration of mechanical ventilation [ Time Frame: Day 14, Day 28, Day 60 ]The investigators will review patients' medical records on day 14 and day 28. Then, the investigators will call patients on day 60. This will be done to determine the efficiency of treatment on duration of mechanical ventilation.
- Time of death [ Time Frame: Day 14, Day 28, Day 60 ]The investigators will review patients' medical records on day 14 and day 28 and calculate number of days death occurred after admission. Then, the investigators will call patients on day 60. This will be done to determine the efficiency of treatment on survival time.
- Cause of death [ Time Frame: Day 14, Day 28, Day 60 ]The investigators will review patients' medical records on day 14 and day 28 and identify the cause of death. Then, the investigators will call patients on day 60. This will be done to determine the effect of treatment on the cause of death.
- Change in biological markers ferritin, procalcitonin and troponin [ Time Frame: Day 14, Day 28, Day 60 ]Biological markers to be measured are: inflammation markers ferritin and procalcitonin, and tissue injury marker troponin. The unit of measure is ng/mL. The investigators will review patients' medical records on day 14 and day 28. Then, the investigators will call patients on day 60. This will be done to determine the efficiency of treatment on improving biological markers associated with COVID-19 infection between admission and occurrence of primary endpoint (2 values at least 2 days apart).
- Change in biological markers C-reactive protein and D-Dimer [ Time Frame: Day 14, Day 28, Day 60 ]Biological markers to be measured are: inflammation marker C-reactive protein and hypercoagulability marker D-Dimer. The unit of measure is mg/L. The investigators will review patients' medical records on day 14 and day 28. Then, the investigators will call patients on day 60 and measure the markers then. This will be done to determine the efficiency of treatment on improving biological markers associated with COVID-19 infection between admission and occurrence of primary endpoint (2 values at least 2 days apart).
- Change in hypercoagulability marker fibrinogen [ Time Frame: Day 14, Day 28, Day 60 ]The unit of measure is g/L. The investigators will review patients' medical records on day 14 and day 28. Then, the investigators will call patients on day 60 and measure the markers then. This will be done to determine the efficiency of treatment on improving hypercoagulability markers associated with COVID-19 infection between admission and occurrence of primary endpoint (2 values at least 2 days apart).
- Change in tissue injury markers ALT, AST and LDH [ Time Frame: Day 14, Day 28, Day 60 ]The investigators will measure Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) and Lactate dehydrogenase (LDH). The unit of measure is U/L. The investigators will review patients' medical records on day 14 and day 28. Then, the investigators will call patients on day 60. This will be done to determine the efficiency of treatment on improving tissue injury markers associated with COVID-19 infection between admission and occurrence of primary endpoint (2 values at least 2 days apart).
- Change in inflammation marker neutrophil:lymphocyte ratio [ Time Frame: Day 14, Day 28, Day 60 ]The investigators will review patients' medical records on day 14 and day 28. Then, the investigators will call patients on day 60. This will be done to determine the efficiency of treatment on improving Inflammation markers associated with COVID-19 infection between admission and occurrence of primary endpoint (2 values at least 2 days apart).
- Grade 3 and 4 adverse events occurrence [ Time Frame: Day 14, Day 28, Day 60 ]The investigators will review patients' medical records on day 14 and day 28. Then, the investigators will call patients on day 60. This will be done to determine the frequency of adverse events in treatment arm vs. placebo arm.
- Serious adverse events occurrence [ Time Frame: Day 14, Day 28, Day 60 ]The investigators will review patients' medical records on day 14 and day 28. Then, the investigators will call patients on day 60. This will be done to determine the frequency of serious adverse events in treatment arm vs. placebo arm.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Hospitalization at Tulane Medical Center in the Department of General Internal Medicine and Geriatrics with COVID-19 (WHO Ordinal scale score 3-5) and confirmed by SARS-CoV-2 Polymerase Chain Reaction (PCR).
- Respiratory symptoms (fever, shortness of breath or cough) or abnormal lung exam or chest imaging characteristic of mild to severe COVID-19 pneumonia.
- Patient and/or legally authorized representative (LAR) agrees to comply with study procedures and the collection of blood samples per protocol.
- Patient and/or LAR agrees to be placed on prophylactic dose of anticoagulation for prevention of deep venous thrombosis (DVT) (if necessary).
- Patient or legally authorized representative has signed informed consent.
- Women of childbearing age with a negative pregnancy test on admission.
Exclusion Criteria:
- Patient under 18 years of age.
- Critical COVID-19 (respiratory failure requiring intubation and mechanical ventilation, shock, multi-organ failure).
- Pregnant women confirmed by pregnancy test.
- Women who are within six weeks of postpartum.
- Patient is not hospitalized at Tulane Medical Center with confirmed COVID-19.
- Patient included in another COVID-19 trial (excluding hydroxychloroquine and dexamethasone).
- Women already treated by estrogen and or progestogen therapy two weeks prior to admission.
- Men already treated by testosterone therapy prior to admission.
- History of breast or endometrial cancer.
- Abnormal genital bleeding.
- Active or recent (e.g., within the past year) stroke or myocardial infarction.
- History of blood clots including deep vein thrombosis related to clotting disease, or pulmonary emboli (prior to hospitalization).
- History of liver dysfunction or disease.
- Patients with end-stage renal disease
- Patients taking inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, and ritonavir.
- Patients taking St. John's Wort preparations (Hypericum perforatum), phenobarbital, carbamazepine, and rifampin.
- Patients within 6 weeks of major orthopedic surgery.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04865029
Contact: Franck Mauvais-Jarvias, MD, PhD | 504-259-1139 | fmauvais@tulane.edu | |
Contact: Dragana Lovre, MD | 504-988-9928 | dlovre@tulane.edu |
United States, Louisiana | |
Tulane University Medical Center | Recruiting |
New Orleans, Louisiana, United States, 70112 | |
Contact: Franck Mauvais-Jarvias, MD, PhD 504-259-1139 fmauvais@tulane.edu | |
Contact: Dragana Lovre, MD 504-988-9928 dlovre@tulane.edu | |
Principal Investigator: Franck Mauvais-Jarvias, MD, PhD | |
Sub-Investigator: Dragana Lovre, MD |
Principal Investigator: | Franck Mauvais-Jarvias, MD, PhD | Tulane University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Tulane University |
ClinicalTrials.gov Identifier: | NCT04865029 |
Other Study ID Numbers: |
2020-939 |
First Posted: | April 29, 2021 Key Record Dates |
Last Update Posted: | July 23, 2021 |
Last Verified: | July 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Estradiol Progesterone Covid19 Estrogen Hormones |
Progestogens Depo-Estradiol Prometrium Micronized Progesterone |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Estradiol 17 beta-cypionate |
Estradiol 3-benzoate Estradiol Polyestradiol phosphate Progesterone Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Contraceptive Agents, Hormonal Contraceptive Agents Reproductive Control Agents Contraceptive Agents, Female Progestins |