SARS-CoV InfectionPhase 1/2NCT04489628
Tele-health Enabled Clinical Trial for COVID-19
A Phase 1/2 study testing Doctella telehealth monitoring in people with SARS-CoV Infection, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV Infection
- What is being tested?
- Doctella telehealth monitoring
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 1 Jun 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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.
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tele-health Enabled Clinical Trial for COVID-19: Vitamin D as an Immunomodulator to Prevent Complications and Reduce Resource Utilization in Outpatients
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
- Being tested
- Vitamin D3 or Placebo, Doctella telehealth monitoring
- Keywords
- Vitamin D, Telehealth, SARS-CoV-2, Immune Storm
- Medical subject headings
- Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3 or PlaceboDrug
): 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 monitoringDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Active comparator | 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. Receives: Drug: Vitamin D3 or Placebo; Device: Doctella telehealth monitoring |
| Placebo | Placebo comparator | 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. Receives: Device: Doctella telehealth monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients requiring admission to the hospital or experiencing death
Proportion of patients requiring admission to the hospital or experiencing death by Day 15
Measured: Days 1 to 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start1 Aug 2020
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Why it stopped: Unable to overcome hurdles to study recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV InfectionStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University
- Responsible party
- Principal investigator, Dr. Kevin Cooper, University Hospitals Cleveland Medical Center
- Investigators
- Kevin Cooper, MD, Principal investigator, University Hospitals Cleveland Medical CenterWesley Yu, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04489628
- Sponsor's protocol ID
- STUDY20200461
- Status last verified
- Feb 2022
- First submitted
- 24 Jul 2020
- Last updated
- 7 Feb 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele-health Enabled Clinical Trial for COVID-19: Vitamin D as an Immunomodulator to Prevent Complications and Reduce Resource Utilization in Outpatients
- ClinicalTrials.gov ID
- NCT04489628
- Acronym / sponsor ID
- STUDY20200461
- Conditions
- SARS-CoV Infection
- Keywords
- Vitamin D, Telehealth, SARS-CoV-2, Immune Storm
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to overcome hurdles to study recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Northwestern University
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 28 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Active comparator | Drug: Vitamin D3 or Placebo, Device: Doctella telehealth monitoringParticipants 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 | Placebo comparator | Device: Doctella telehealth monitoringParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Vitamin D |
| Doctella telehealth monitoringDoctella 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. | Device | Placebo, Vitamin D |
Primary outcome
Patients requiring admission to the hospital or experiencing death
Time frame: Days 1 to 15
Proportion of patients requiring admission to the hospital or experiencing death by Day 15
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Cooper, MD principal investigator
University Hospitals Cleveland Medical Center
Wesley Yu, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Doctella telehealth monitoring in people with SARS-CoV Infection, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients requiring admission to the hospital or experiencing death (time frame: Days 1 to 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2022.