COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04531748

Samantha Wells

wellss@ccf.org

2020-08-28

Withdrawn

RCT

Randomized

Parallel

Blind label

unclear

Treatment

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

- 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

3

Reena Mehra, MD

18

100

None

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

0

Peak increase in COVID-19 Sign and Symptom score

None

Phase 2

[{"arm_notes": "", "treatment_id": 1625, "treatment_name": "Melatonin+toremifene", "treatment_type": "Central nervous system agents+others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 779, "treatment_name": "Melatonin", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]