Tele-health Enabled Clinical Trial for COVID-19

NCT ID: NCT04489628

Last Updated: 2022-02-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2021-06-01

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.

Conditions

SARS-CoV Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Vitamin D

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.

Group Type: ACTIVE_COMPARATOR

Vitamin D3 or Placebo

Intervention Type: DRUG

): 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.

Doctella telehealth monitoring

Intervention Type: DEVICE

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.

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.

Group Type: PLACEBO_COMPARATOR

Doctella telehealth monitoring

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DRUG

Doctella telehealth monitoring

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: collaborator

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Dr. Kevin Cooper

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kevin Cooper, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Wesley Yu, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STUDY20200461

Identifier Type: -

Identifier Source: org_study_id