Tele-health Enabled Clinical Trial for COVID-19

• Status: Terminated
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospitals Cleveland Medical Center
• Collaborator: Northwestern University
• Treatments: Cholecalciferol; Vitamin D

Criteria

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