Selective Estrogen Modulation and Melatonin in Early COVID-19

• Status: Withdrawn
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a randomized, double-blind, controlled clinical trial to evaluate the effects of toremifene and/or melatonin in adults with mild COVID-19.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Reena Mehra, MD
• Treatments: Melatonin; Toremifene

Criteria

Inclusion Criteria:

• Clinical testing positive for SARS-Cov-2 by standard RT-PCR or equivalent test

• Willing and able to give informed consent for participation in the study and agrees with the study and its conduct

• Age>18 years

• Fluency in English or Spanish language, functional literacy

• Able to swallow pills

• COVID-19 Daily Sign and Symptom score of 2-8

Exclusion Criteria:

• History of deep venous thrombosis or pulmonary embolism

• Hypercoagulable disorders (e.g. lupus anticoagulant, deficiency of protein C or S)

• Embolic stroke

• Liver disease

• History of endometrial cancer

• Menopausal hormone therapy or oral, injectable or transdermal contraceptives

• Depression which is not optimally treated (assessed via medical record and patient will be asked if she/he feels that depression is optimally treated)

• Medications which prolong the QT interval (e.g. hydroxychloroquine or azithromycin) or those with long QT syndrome (heritable or acquired). Examples of other medications which prolong the QT interval include: Agents generally accepted to prolong QT interval include Class 1A (e.g., quinidine, procainamide, disopyramide) and Class III (e.g., amiodarone, sotalol, ibutilide, dofetilide) antiarrhythmics; certain antipsychotics (e.g., thioridazine, haloperidol); certain antidepressants (e.g., venlafaxine, amitriptyline); certain antibiotics (e.g., erythromycin, clarithromycin, levofloxacin, ofloxacin); and certain anti-emetics (e.g., ondansetron, granisetron) (Please refer to Appendix for detailed list of medications)

• Inability to participate in follow up assessment

• Dementia/cognitive dysfunction

• Pregnancy (pregnancy testing will be performed to determine eligibility)

• Breastfeeding

• Participating in other COVID-19 trials

• Immunodeficiency (including HIV, Hepatitis C, bone marrow transplant history, on immunosuppressant medications)

• Current hospitalization

• Seizure disorder

• History of rheumatoid arthritis

• Heart failure (NYHA Class III or IV)

• Current diagnosis of renal insufficiency/failure

• QTc >470ms per 12-lead ECG

• Calcium >10.2mg/dL

• AST or ALT > 2x upper limit of normal (ULN)

• D-dimer >= 1000 u/L

• Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2

• On other treatment(s) for COVID-19 (e.g. hydroxychloroquine, remdesivir)

• Anticoagulant medications (e.g. coumadin, glycoprotein IIa/IIIb inhibitors)

• Clinical signs of severe or critical severity of COVID-19 (e.g. shortness of breath at rest, Respiratory rate ≥ 30 per minute, heart rate ≥ 125 per minute, SpO2 ≤ 93% on room air)

• Use of supplemental oxygen

• Moderate to severe pulmonary disease up to PI discretion