Estradiol and Progesterone in Hospitalized COVID-19 Patients

• ClinicalTrials.gov Identifier: NCT04865029
• Recruitment Status: Recruiting
• First Posted: April 29, 2021
• Last Update Posted: July 23, 2021
• Sponsor: Tulane University
• Information provided by (Responsible Party): Tulane University

Study Description

Brief Summary:

The purpose of this study is to determine to what extent a short systemic steroid therapy with estradiol and progesterone, administered early to hospitalized and confirmed COVID-19 positive patients of both sexes in addition to standard of care (SOC) can reduce the severity of symptoms and outcomes compared to SOC alone.

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

Detailed Description:

Coronavirus Severe Acute Respiratory Syndrome (SARS-CoV-2), causing COVID-19, has killed over 2.8 million people globally, including 550,000 in the US as of March 2021. Although, the vaccination campaign is ramping up, vaccination hesitancy in the United States represents up to 25-30% of the population, and hospitalizations and deaths are still at the level of 2020. Apart from corticosteroids, most available therapeutic options are at best marginally efficient in reducing disease severity and mortality and extremely expensive. Therefore, the systematic investigation of clinically approved drugs is a priority in order to determine what does improve the disease and invest resources to go to full-scale production. Our current understanding of the disease is that COVID-19 deaths result from an inappropriate immune response with outpouring of pro-inflammatory chemokines leading to lung infiltration and hyperactivation of monocytes and macrophages producing pro-inflammatory cytokines (cytokine storm), resulting in lung edema, reduced gas exchange, and ultimately leading to acute respiratory distress syndrome and multiorgan failure. Men with COVID-19 have a uniformly more severe outcome than women. In series from China, Europe and the U.S., COVID-19 mortality was consistently 1.5 to 2-fold higher in men than in women, suggesting that female biological sex is protecting women from COVID-19 mortality. It is established that women exhibit heightened immune responses to viral infections compared to men, which is at least partially due to the genetic benefit of gene dosage in X-linked immune-response genes. Ovarian steroids, however, also play a protective role. In New York City, among 5700 hospitalized patients, the female protection from COVID-19 mortality was observed at all ages, but was more pronounced in subjects under 50 years of age (18% mortality in women) compared to patients > 50 years of age (40.5% mortality in women), suggesting that ovarian steroids are involved in mitigating COVID-19 mortality in pre-menopausal women. Further, the analysis of electronic health records of over 68,000 COVID-19 patients revealed that estrogen therapy is associated with more than 50% reduction in mortality. The main female steroids, 17β-estradiol and progesterone exhibit potent immuno-modulatory and anti-inflammatory actions via estrogen and progesterone receptors expressed in all immune cells, including epithelial cells, macrophages, dendritic cells, cluster of differentiation 4 (CD4+) and cluster of differentiation 8 (CD8+) lymphocytes, and B cells. Progesterone also acts partially via the glucocorticoid receptor. Together estradiol and progesterone produce a state of decreased innate immune cells production of proinflammatory cytokines, enhanced T cells anti-inflammatory responses and immune tolerance, and enhanced B-cell-mediated antibody production. The National Institutes of Health (NIH) COVID-19 Treatment Guidelines Panel recommends the use of dexamethasone 6 mg per day for up to 10 days or until hospital Discharge (whichever comes first) as standard of care (SOC) for the treatment of hospitalized COVID-19 patients who require supplemental oxygen but who are not mechanically ventilated and for the treatment of hospitalized patients who are mechanically ventilated. Remdesivir is SOC at Tulane for COVID-19 patients who require supplemental oxygen but who are not mechanically ventilated. We believe that in hospitalized COVID-19 patients, a short treatment with the combination estradiol and progesterone, administered early and as a prevention in addition to SOC, will prevent or mitigate the cytokine storm while increasing antibody production and prevent severe outcomes, without side effects. Therefore, it will provide steroid immunomodulation without immunosuppression. The advantage of repurposing estradiol and progesterone compounds is the depth of knowledge regarding their clinical efficacy and toxicity that has accumulated from decades of clinical and basic studies. Estradiol and progesterone are widely available in hospitals, inexpensive, manufacturable to scale, and can be prescribed immediately.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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).
7. 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).
8. 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).
9. 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).
10. 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).
11. 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.
12. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. 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).
2. Respiratory symptoms (fever, shortness of breath or cough) or abnormal lung exam or chest imaging characteristic of mild to severe COVID-19 pneumonia.
3. Patient and/or legally authorized representative (LAR) agrees to comply with study procedures and the collection of blood samples per protocol.
4. Patient and/or LAR agrees to be placed on prophylactic dose of anticoagulation for prevention of deep venous thrombosis (DVT) (if necessary).
5. Patient or legally authorized representative has signed informed consent.
6. Women of childbearing age with a negative pregnancy test on admission.

Exclusion Criteria:

1. Patient under 18 years of age.
2. Critical COVID-19 (respiratory failure requiring intubation and mechanical ventilation, shock, multi-organ failure).
3. Pregnant women confirmed by pregnancy test.
4. Women who are within six weeks of postpartum.
5. Patient is not hospitalized at Tulane Medical Center with confirmed COVID-19.
6. Patient included in another COVID-19 trial (excluding hydroxychloroquine and dexamethasone).
7. Women already treated by estrogen and or progestogen therapy two weeks prior to admission.
8. Men already treated by testosterone therapy prior to admission.
9. History of breast or endometrial cancer.
10. Abnormal genital bleeding.
11. Active or recent (e.g., within the past year) stroke or myocardial infarction.
12. History of blood clots including deep vein thrombosis related to clotting disease, or pulmonary emboli (prior to hospitalization).
13. History of liver dysfunction or disease.
14. Patients with end-stage renal disease
15. Patients taking inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, and ritonavir.
16. Patients taking St. John's Wort preparations (Hypericum perforatum), phenobarbital, carbamazepine, and rifampin.
17. Patients within 6 weeks of major orthopedic surgery.

Contacts and Locations

Contacts

Contact: Franck Mauvais-Jarvias, MD, PhD; 504-259-1139; fmauvais@tulane.edu

Contact: Dragana Lovre, MD; 504-988-9928; dlovre@tulane.edu

Locations

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

Sponsors and Collaborators

Tulane University

Investigators

• Principal Investigator: Franck Mauvais-Jarvias, MD, PhD; Tulane University

More Information

Publications:

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Tanaka T, Narazaki M, Kishimoto T. Immunotherapeutic implications of IL-6 blockade for cytokine storm. Immunotherapy. 2016 Jul;8(8):959-70. doi: 10.2217/imt-2016-0020. Review.

McGonagle D, Sharif K, O'Regan A, Bridgewood C. The Role of Cytokines including Interleukin-6 in COVID-19 induced Pneumonia and Macrophage Activation Syndrome-Like Disease. Autoimmun Rev. 2020 Jun;19(6):102537. doi: 10.1016/j.autrev.2020.102537. Epub 2020 Apr 3. Review.

Mauvais-Jarvis F, Bairey Merz N, Barnes PJ, Brinton RD, Carrero JJ, DeMeo DL, De Vries GJ, Epperson CN, Govindan R, Klein SL, Lonardo A, Maki PM, McCullough LD, Regitz-Zagrosek V, Regensteiner JG, Rubin JB, Sandberg K, Suzuki A. Sex and gender: modifiers of health, disease, and medicine. Lancet. 2020 Aug 22;396(10250):565-582. doi: 10.1016/S0140-6736(20)31561-0. Review. Erratum in: Lancet. 2020 Sep 5;396(10252):668.

Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.

Richardson S, Hirsch JS, Narasimhan M, Crawford JM, McGinn T, Davidson KW; the Northwell COVID-19 Research Consortium, Barnaby DP, Becker LB, Chelico JD, Cohen SL, Cookingham J, Coppa K, Diefenbach MA, Dominello AJ, Duer-Hefele J, Falzon L, Gitlin J, Hajizadeh N, Harvin TG, Hirschwerk DA, Kim EJ, Kozel ZM, Marrast LM, Mogavero JN, Osorio GA, Qiu M, Zanos TP. Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area. JAMA. 2020 May 26;323(20):2052-2059. doi: 10.1001/jama.2020.6775. Erratum in: JAMA. 2020 May 26;323(20):2098.

Klein SL, Dhakal S, Ursin RL, Deshpande S, Sandberg K, Mauvais-Jarvis F. Biological sex impacts COVID-19 outcomes. PLoS Pathog. 2020 Jun 22;16(6):e1008570. doi: 10.1371/journal.ppat.1008570. eCollection 2020 Jun.

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Mauvais-Jarvis F, Klein SL, Levin ER. Estradiol, Progesterone, Immunomodulation, and COVID-19 Outcomes. Endocrinology. 2020 Sep 1;161(9). pii: bqaa127. doi: 10.1210/endocr/bqaa127. Review.

Mauvais-Jarvis F, Manson JE, Stevenson JC, Fonseca VA. Menopausal Hormone Therapy and Type 2 Diabetes Prevention: Evidence, Mechanisms, and Clinical Implications. Endocr Rev. 2017 Jun 1;38(3):173-188. doi: 10.1210/er.2016-1146. Review.

Mauvais-Jarvis F. Aging, Male Sex, Obesity, and Metabolic Inflammation Create the Perfect Storm for COVID-19. Diabetes. 2020 Sep;69(9):1857-1863. doi: 10.2337/dbi19-0023. Epub 2020 Jul 15.

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lovre D, Bateman K, Sherman M, Fonseca VA, Lefante J, Mauvais-Jarvis F. Acute estradiol and progesterone therapy in hospitalised adults to reduce COVID-19 severity: a randomised control trial. BMJ Open. 2021 Nov 30;11(11):e053684. doi: 10.1136/bmjopen-2021-053684.

• Responsible Party: Tulane University
• ClinicalTrials.gov Identifier: NCT04865029
• Other Study ID Numbers: 2020-939
• First Posted: April 29, 2021
• 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

Keywords provided by Tulane University:

Estradiol; Progesterone; Covid19; Estrogen; Hormones; Progestogens; Depo-Estradiol; Prometrium; Micronized Progesterone

Additional relevant MeSH terms:

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