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Tele-health Enabled Clinical Trial for COVID-19

NCT04489628 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2022-02-07

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Kevin Cooper, MD · University Hospitals Cleveland Medical Center

  • Wesley Yu, MD · University Hospitals Cleveland Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2021-06-01
Completion
2021-06-01
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04489628 on ClinicalTrials.gov