NCT04489628

Tele-health Enabled Clinical Trial for COVID-19

Tele-health Enabled Clinical Trial for COVID-19: Vitamin D as an Immunomodulator to Prevent Complications and Reduce Resource Utilization in Outpatients

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine the efficacy of high dose Vitamin D (an over-the-counter nutritional supplement) in preventing immune-related complications in outpatients with confirmed SARS-CoV-2 infection.

Conditions

• SARS-CoV Infection

Interventions

Type	Name	Description
DRUG	Vitamin D3 or Placebo	): Participants will be given 8 capsules of either cholecalciferol 50,000 IU or placebo at study randomization. Participants will be instructed to take 4 capsules on receipt of the treatment package(Day 0), 2 capsules on Day 5, 1 capsule on Day 10, and 1 capsule on Day 15. A phone or text reminder will be included at Days 5, 10, and 15 to take the additional doses of vitamin D.
DEVICE	Doctella telehealth monitoring	Doctella device will be give to participants by the Emergency department as part of usual care to monitor heart rate, respiratory rate, oxygen saturation, and perfusion index vitals continuously for approximately 10 days. The study team will receive the vitals signs data (heart rate, respiratory rate, oxygen saturation, perfusion index, and temperature) retrospectively and will not be able to monitor patients in real time.

Timeline

• Start date: 2020-08-01
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2020-07-28
• Last updated: 2022-02-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study