Status:
WITHDRAWN
Tele-health Enabled Clinical Trial for COVID-19
Lead Sponsor:
University Hospitals Cleveland Medical Center
Collaborating Sponsors:
Northwestern University
Conditions:
SARS-CoV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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.
Eligibility Criteria
Inclusion
- ≥ 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
- 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
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04489628
Start Date
August 1 2020
End Date
June 1 2021
Last Update
February 7 2022
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611