Tele-health Enabled Clinical Trial for COVID-19

Study Overview
=================
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.

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

Conditions
-----------------
SARS-CoV Infection

Intervention / Treatment
-----------------
* Drug: Vitamin D3 or Placebo
* Device: Doctella telehealth monitoring


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin D<br>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. | Drug: Vitamin D3 or Placebo<br>* ): 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.<br>Device: Doctella telehealth monitoring<br>* 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.<br>|
| Placebo Comparator: Placebo<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin D, Telehealth, SARS-CoV-2, Immune Storm