Covid19NCT04530539
The Effect of Melatonin and Vitamin C on COVID-19
A study testing Vitamin C, melatonin and Symptom Survey in people with Covid19 and SARS-CoV Infection, run by Lancaster General Hospital at 1 site in United States.
Trial summary
This is a double-blind placebo controlled trial that seeks to evaluate the impact of melatonin and vitamin C on symptoms and outcomes of patients with COVID-19. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, SARS-CoV Infection
- What is being tested?
- Vitamin C, melatonin and Symptom Survey
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2020to 11 Aug 2022
- Phase
- Interventional
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- COVID-19 positive test (outpatient testing),
- Age >50 (chosen based greater risk for older patients to be vitamin deficient, age >65 not used so as not to be too restrictive in the inclusion criteria)
- Experiencing symptoms for <5 days prior to enrollment
- Able to read and write in English or Spanish
- Able to access REDCap daily
- Valid email address
- Current has a Lancaster General Health primary care physician
Who cannot join
- COVID-19 test ordered pre-procedure for asymptomatic screening
- Currently taking vitamin C supplements
- Currently taking melatonin supplements
- Currently hospitalized
- Deceased
- Currently pregnant
- Currently incarcerated
Trial locations and contacts
1 site in 1 country.
United States1 site
Lancaster General Health
Lancaster, Pennsylvania, 17602
About this study
This is a double-blind placebo controlled trial that seeks to evaluate the impact of melatonin and vitamin C on symptoms and outcomes of patients with COVID-19.
- Conditions
- Covid19, SARS-CoV Infection
- Keywords
- vitamin c, melatonin
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDietary supplement
Also called ascorbic acid
1000mg Vitamin C, at bedtime
melatoninDietary supplement
10mg melatonin, at bedtime
PlaceboDietary supplement
Placebo at bedtime
Symptom SurveyOther
Daily symptom survey to be completed by patient electronically
| Study group | Role | What they receive |
|---|---|---|
| Experimental- Melatonin | Experimental | Patients will receive melatonin Receives: Dietary Supplement: melatonin; Other: Symptom Survey |
| Experimental- Vit C | Experimental | Patients will receive vitamin C Receives: Dietary Supplement: Vitamin C; Other: Symptom Survey |
| Control | Placebo comparator | Patients will receive placebo Receives: Dietary Supplement: Placebo; Other: Symptom Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Severity
Symptom severity will be tracked electronically
Measured: 14 days
Secondary outcomes (1)
Symptom progression
Determine symptom course of those with moderate or severe symptoms
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start5 Oct 2020
- Primary completion11 Aug 2022
- Study completion11 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lancaster General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Corey Fogleman, Principal investigator, Penn Medicine Lancaster General HealthCorey Fogleman, MD, Principal investigator, Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04530539
- Sponsor's protocol ID
- 2020-68
- Status last verified
- Aug 2022
- First submitted
- 26 Aug 2020
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Melatonin and Vitamin C on COVID-19
- ClinicalTrials.gov ID
- NCT04530539
- Acronym / sponsor ID
- 2020-68
- Conditions
- Covid19, SARS-CoV Infection
- Keywords
- vitamin c, melatonin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Lancaster General HospitalUniversity, hospital or other
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 11 Aug 2022 (actual)
- Study completion
- 11 Aug 2022 (actual)
- First posted
- 28 Aug 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.
This is a double-blind placebo controlled trial that seeks to evaluate the impact of melatonin and vitamin C on symptoms and outcomes of patients with COVID-19.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental- Melatonin | Experimental | Dietary Supplement: melatonin, Other: Symptom SurveyPatients will receive melatonin |
| Experimental- Vit C | Experimental | Dietary Supplement: Vitamin C, Other: Symptom SurveyPatients will receive vitamin C |
| Control | Placebo comparator | Dietary Supplement: Placebo, Other: Symptom SurveyPatients will receive placebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- COVID-19 positive test (outpatient testing),
- Age >50 (chosen based greater risk for older patients to be vitamin deficient, age >65 not used so as not to be too restrictive in the inclusion criteria)
- Experiencing symptoms for <5 days prior to enrollment
- Able to read and write in English or Spanish
- Able to access REDCap daily
Key exclusion criteria (7 listed)
- COVID-19 test ordered pre-procedure for asymptomatic screening
- Currently taking vitamin C supplements
- Currently taking melatonin supplements
- Currently hospitalized
- Deceased
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 CAlso: ascorbic acid1000mg Vitamin C, at bedtime | Dietary supplement | Experimental- Vit C |
| melatonin10mg melatonin, at bedtime | Dietary supplement | Experimental- Melatonin |
| PlaceboPlacebo at bedtime | Dietary supplement | Control |
| Symptom SurveyDaily symptom survey to be completed by patient electronically | Other | Control, Experimental- Melatonin, Experimental- Vit C |
Primary outcome
Symptom Severity
Time frame: 14 days
Symptom severity will be tracked electronically
1 secondary outcome
Symptom progression
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 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.
Corey Fogleman principal investigator
Penn Medicine Lancaster General Health
Corey Fogleman, MD principal investigator
Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin C, melatonin and Symptom Survey in people with Covid19 and SARS-CoV Infection, run by Lancaster General Hospital 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 17 Aug 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Symptom Severity (time frame: 14 days). 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 17 Aug 2022.