Tele-health Enabled Clinical Trial for COVID-19

University Hospitals (UH)

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: SARS-CoV Infection

Treatments: Device: Doctella telehealth monitoring; Drug: Vitamin D3 or Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04489628

STUDY20200461

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Vitamin D

Active Comparator group

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.

Treatment:

Device: Doctella telehealth monitoring

Drug: Vitamin D3 or Placebo

Placebo

Placebo Comparator group

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.

Treatment:

Device: Doctella telehealth monitoring