Tele-health Enabled Clinical Trial for COVID-19

Phase 1

Withdrawn

• Conditions: SARS-CoV Infection
• Interventions: Drug: Vitamin D3 or Placebo; Device: Doctella telehealth monitoring

• Registration Number: NCT04489628
• Lead Sponsor: University Hospitals Cleveland Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-24
• Study First Submitted QC: 2020-07-24
• Study First Posted: 2020-07-28
• Study Start: 2020-08-01
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-04
• Last Update Posted: 2022-02-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D	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.
Vitamin D	Doctella telehealth monitoring	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.
Placebo	Doctella telehealth monitoring	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.

Primary Outcome Measures

Name	Time	Method
Patients requiring admission to the hospital or experiencing death	Days 1 to 15	Proportion of patients requiring admission to the hospital or experiencing death by Day 15

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States