NCT04531748

Selective Estrogen Modulation and Melatonin in Early COVID-19

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Reena Mehra, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a randomized, double-blind, controlled clinical trial to evaluate the effects of a 14 day intervention of toremifene plus melatonin or melatonin in adults with mild COVID-19. The study will evaluate the progression of clinical signs and symptoms (fever, dyspnea, cough, fatigue daily score) and any adverse outcomes in comparison to placebo for 30 days. The successful completion of this project offers high potential to identify effective treatment (e.g., toremifene plus melatonin and/or melatonin) rapidly for patients with early COVID-19 and to provide, important, fundamental mechanistic insights.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	Toremifene	Participants will be instructed to take 60mg of oral toremifene capsule daily, 30 minutes before bedtime.
DRUG	Melatonin	Participants will be instructed to take the pills orally around the same time in the morning and 30 minutes prior to bedtime in the evening.
OTHER	Placebo	Oral placebo will be used with the same number and appearance to the pills as the interventions.

Timeline

• Start date: 2021-12-01
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2020-08-28
• Last updated: 2021-05-10

Regulatory

• FDA-regulated drug study