Covid19 Clinical Trial
— SENTINELOfficial title:
Selective Estrogen Modulation and Melatonin in Early COVID-19
NCT number | NCT04531748 |
Other study ID # | 20-842 |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | December 2021 |
Est. completion date | September 2022 |
Verified date | May 2021 |
Source | The Cleveland Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 2022 |
Est. primary completion date | September 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Reena Mehra, MD |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Peak increase in COVID-19 Sign and Symptom score | Score total of 0-12 assessed daily. Each category based on severity of symptoms of Cough, Shortness of breath, Fatigue/tiredness and daily temperature on a rating scale of 0-3. | Screening to 28 days | |
Secondary | Nadir Oxygen Saturation | Daily mean values | Day 1 through day 14 | |
Secondary | Peak Heart Rate | Daily mean values | Day 1 through day 14 | |
Secondary | Time to COVID-19 Sign and Symptom score resolution | Score total of 0-12 assessed daily. Each category based on severity of symptoms of Cough, Shortness of breath, Fatigue/tiredness and daily temperature on a rating scale of 0-3. | Screening to 28 days | |
Secondary | Time to WHO 7-point ordinal scale score of 3 or higher | not hospitalized, no limitation of activities (or resumption of normal activity) not hospitalized but limitation on activities hospitalized, not requiring supplemental oxygen hospitalized, requiring supplemental oxygen (low-flow, e.g., nasal prong) hospitalized, requiring non-invasive ventilation and/or high-flow oxygen hospitalized, on invasive ventilation or ECMO death |
Day 1 to Day 30 |
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