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Tele-health Enabled Clinical Trial for COVID-19

Primary Purpose

SARS-CoV Infection

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Vitamin D3 or Placebo
Doctella telehealth monitoring
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SARS-CoV Infection focused on measuring Vitamin D, Telehealth, SARS-CoV-2, Immune Storm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. ≥ 18 years of age
  2. Laboratory confirmed SARS-CoV-2 infection < 4 days before randomization
  3. Report of symptoms consistent with SARS-CoV-2 infection (including but not limited to fever, cough, muscle aches, joint pain, change in taste, change in smell, or shortness of breath) <4 days before admission
  4. Asymptomatic or mild symptoms (not requiring hospital admission)
  5. Access to and ability to use a mobile phone with telehealth capability

Exclusion Criteria:

  1. Unable to provide informed consent or comply with study directions
  2. Admitted to an acute care bed
  3. Baseline serum calcium < 8.8 mg/dL or > 10.2 mg/dl (as evaluated by labs taken in the ER/urgent care)
  4. Women who are currently breastfeeding
  5. History of kidney stone in the past year or h/o multiple (>1) previous kidney stones
  6. Does not have a smart phone that can download apps from Google Play or App Store.
  7. No way to keep the phone charged consistently
  8. The smartphone is shared with another individual.
  9. Required laboratory data is unavailable (eg calcium levels)
  10. No new oxygen requirement (see remote monitoring document)
  11. Pregnant and lactating mothers.
  12. Vitamin D level of 80ng/ml and above
  13. No lab work for calcium or vitamin D completed in ED

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Vitamin D

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Patients requiring admission to the hospital or experiencing death
Proportion of patients requiring admission to the hospital or experiencing death by Day 15

Secondary Outcome Measures

Full Information

First Posted
July 24, 2020
Last Updated
February 4, 2022
Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT04489628
Brief Title
Tele-health Enabled Clinical Trial for COVID-19
Official Title
Tele-health Enabled Clinical Trial for COVID-19: Vitamin D as an Immunomodulator to Prevent Complications and Reduce Resource Utilization in Outpatients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to overcome hurdles to study recruitment
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
June 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV Infection
Keywords
Vitamin D, Telehealth, SARS-CoV-2, Immune Storm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Vitamin D3 or Placebo
Intervention Description
): 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.
Intervention Type
Device
Intervention Name(s)
Doctella telehealth monitoring
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patients requiring admission to the hospital or experiencing death
Description
Proportion of patients requiring admission to the hospital or experiencing death by Day 15
Time Frame
Days 1 to 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥ 18 years of age Laboratory confirmed SARS-CoV-2 infection < 4 days before randomization Report of symptoms consistent with SARS-CoV-2 infection (including but not limited to fever, cough, muscle aches, joint pain, change in taste, change in smell, or shortness of breath) <4 days before admission Asymptomatic or mild symptoms (not requiring hospital admission) Access to and ability to use a mobile phone with telehealth capability Exclusion Criteria: Unable to provide informed consent or comply with study directions Admitted to an acute care bed Baseline serum calcium < 8.8 mg/dL or > 10.2 mg/dl (as evaluated by labs taken in the ER/urgent care) Women who are currently breastfeeding History of kidney stone in the past year or h/o multiple (>1) previous kidney stones Does not have a smart phone that can download apps from Google Play or App Store. No way to keep the phone charged consistently The smartphone is shared with another individual. Required laboratory data is unavailable (eg calcium levels) No new oxygen requirement (see remote monitoring document) Pregnant and lactating mothers. Vitamin D level of 80ng/ml and above No lab work for calcium or vitamin D completed in ED
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Cooper, MD
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wesley Yu, MD
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Tele-health Enabled Clinical Trial for COVID-19

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