Tele-health Enabled Clinical Trial for COVID-19

SARS-CoV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04489628
• Other study ID #: STUDY20200461
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: August 1, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: February 2022
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center	Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients requiring admission to the hospital or experiencing death	Proportion of patients requiring admission to the hospital or experiencing death by Day 15	Days 1 to 15