COVID-19COVit-2NCT04751604
Improvement of the Nutritional Status Regarding Nicotinamide (Vitamin B3) and the Disease Course of COVID-19
A study testing Nicotinamide in people with COVID-19, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial summary
Based on the literature, it seems likely that a nutritional intervention with nicotinamide (a form of vitamin B3) can support the therapy of SARS-CoV-2 infection (COVID-19). A pilot phase of the COVit trial showed an effect of nicotinamide on the time to complete resolution of COVID-19 symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Nicotinamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 900 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2021to 20 Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is of age (at least 18 years).
- SARS-CoV-2 infection confirmed by laboratory findings; the positive test must not date back more than 7 days.
- Relevant infection symptoms, e.g. in the respiratory or gastrointestinal tract.
- The patient has been able to give written consent via a website before any trial procedure is performed and can comply with the trial-dependent prerequisites and requirements.
Who cannot join
- Current participation in another trial.
- Pregnancy or breastfeeding.
- Vaccination against SARS-CoV-2.
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Schleswig-Holstein
Kiel, Schleswig-Holstein, 24105
About this study
Based on the literature, it seems likely that a nutritional intervention with nicotinamide (a form of vitamin B3) can support the therapy of SARS-CoV-2 infection (COVID-19). A pilot phase of the COVit trial showed an effect of nicotinamide on the time to complete resolution of COVID-19 symptoms. In addition, diarrhoea is a common symptom of COVID-19. Therefore, in a second part of the study, 420 symptomatic patients each with confirmed SARS-CoV-2 infection are to take 1,000 mg nicotinamide (500 mg conventional nicotinamide and 500 mg nicotinamide released in a controlled manner in the intestine) or corresponding placebos per day in a blinded fashion for 4 weeks. The primary endpoint of the trial is the occurrence of individual COVID-19 symptoms over time (primary analysis time point: week 2). Secondary endpoints focus on the severity of COVID-19 symptoms, the post-COVID-19 syndrome (PCS), anti-SARS-CoV-2 antibody levels, and the time to resolution of individual or all symptoms. Exploratory endpoints include the WHO clinical scale for COVID-19, development of severe COVID-19, fatigue, quality of life and biomarkers. Patients are approached after positive testing and give their informed consent online. After randomised distribution of the trial supplements, patients are interviewed by telephone about their disease course at baseline (week 0), week 2, week 4, week 6 and after 6 months. Stool samples are collected from up to 400 patients at the same timepoints. In addition to blood count and standard blood profile, various inflammatory markers and the metabolome, in particular tryptophan metabolism, are examined in the blood of up to 20 selected patients. In these patients, the viral strain is determined by sequencing from nasopharyngeal swabs. In selected patients, short-term pharmacokinetics of nicotinamide, nicotinic acid and nicotinuric acid as well as of metabolites of nicotinamide and tryptophan are investigated. In the stool, changes in the microbiome (in 100-300 patients) as well as metagenome and metabolome (in a subgroup) will be analysed. The study is expected to produce rapid results on whether nicotinamide supplementation can alleviate the disease course of COVID-19. Moreover, a follow-up interview, a smell test, a cognitive test and anti-SARS-CoV-2 antibody levels after at least 6 months will be used to investigate whether the supplementation has any influence on PCS as well as the immune reaction against SARS-CoV-2.
- Conditions
- COVID-19
- Being tested
- Nicotinamide, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicotinamideDietary supplement
Daily oral administration of 1,000 mg nicotinamide [1x 500-mg conventional nicotinamide tablet and 1x 500-mg tablet with controlled-ileocolonic-release nicotinamide (CICR-NAM)] for 4 weeks
PlaceboDietary supplement
Daily oral administration of 2 matching placebo tablets for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Nicotinamide | Experimental | Daily oral administration of 1,000 mg nicotinamide [1x 500-mg conventional nicotinamide tablet and 1x 500-mg tablet with controlled-ileocolonic-release nicotinamide (CICR-NAM)] for 4 weeks Receives: Dietary Supplement: Nicotinamide |
| Placebo | Placebo comparator | Daily oral administration of 2 matching placebo tablets for 4 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequencies of individual COVID-19 symptoms at week 0, week 2 (primary time of analysis), week 4 and week 6 as well as after 6 months.
A broad range of symptoms is recorded during telephone interviews at baseline, at weeks 2, 4 and 6 and after 6 months in an electronic case report form. Key symptoms include performance drop / limited physical capacity, the ability to perform normal activities, cough and fatigue. A complaint scale for lower respiratory tract infections is queried with the aspects of cough, mucus production, shortness of breath, sleep, ability to perform normal activities, and general feeling of illness, with gradations from 0 = normal to 6 = maximally poor. In addition, patient-reported outcomes by paper questionnaires are recorded: SF-36 V.1.0 and FACIT-F are completed in parallel to the telephone interviews from baseline to through study completion (up to 6 months); a subgroup of patients records daily changes in symptom occurrence and severity during the time of dietary supplementation (4 weeks), with gradations from 0 = not at all to 4 = intolerable.
Measured: Through study completion, up to 6 months
Secondary outcomes (8)
Severity of individual COVID-19 symptoms at week 0, week 2 (primary time of analysis), week 4 and week 6 as well as after 6 months.
Symptoms are recorded during telephone interviews at baseline, at weeks 2, 4 and 6 and after 6 months in an electronic case report form and as patient-reported outcomes by paper questionnaires (SF-36 V.1.0, FACIT-F, 4-week daily symptom questionnaire).
Measured: Through study completion, up to 6 months
Frequency and severity of symptoms characteristic of post-COVID-19 syndrome (at month 6).
A validated smell test (Smell Identification Test™; Sensonics / MediSense) is performed by the patient and recorded as patient-reported outcome by a paper questionnaire. Questionnaires on olfactory and gustatory abilities (incl. Questionnaire of Olfactory Disorders, QOD), respiration (Multidimensional Dyspnoea Profile, MDP), mental state (Patient Health Questionnaire Depression, PHQ-8; Generalised Anxiety Disorder 7, GAD-7; Perceived Stress Scale, PSS; Brief Resilience Scale, BRS), sleep quality (Pittsburgh Sleep Quality Index, PSQI) and fatigue (Multidimensional Fatigue Inventory, MFI) are recorded as patient-reported outcomes by paper questionnaires. In addition, a cognition test (T3MS) validated for telephone interviews will be performed.
Measured: 6 months
3. Levels of antibodies directed against the N protein or S protein of SARS-CoV-2 after at least 6 months (anti-S protein stratified for presence and type of booster vaccination).
ELISA measurements of antibodies recovered from dried blood spots are performed using a validated procedure in a central laboratory.
Measured: 6 months
Frequency of complete symptom resolution after 2 weeks of dietary supplementation.
Symptoms are recorded during telephone interviews at baseline and at week 2 in an electronic case report form and as patient-reported outcomes by paper questionnaires (SF-36 V.1.0, FACIT-F, 4-week daily symptom questionnaire).
Measured: 2 weeks
Frequency of complete symptom resolution after 4 weeks of dietary supplementation.
Symptoms are recorded during telephone interviews at baseline and at week 4 in an electronic case report form and as patient-reported outcomes by paper questionnaires (SF-36 V.1.0, FACIT-F, 4-week daily symptom questionnaire).
Measured: 4 weeks
Frequency of complete symptom resolution after 6 weeks (4 weeks of dietary supplementation and 2 weeks follow-up).
Symptoms are recorded during telephone interviews at baseline and at week 6 in an electronic case report form and as patient-reported outcomes by paper questionnaires (SF-36 V.1.0 and FACIT-F).
Measured: 6 weeks
Time from diagnosis resolution of individual symptoms [days].
Symptoms are recorded during telephone interviews at baseline and at weeks 2, 4 and 6 in an electronic case report form and as patient-reported outcomes by paper questionnaires (SF-36 V.1.0, FACIT-F, 4-week daily symptom questionnaire).
Measured: 6 weeks
Time from diagnosis to complete symptom resolution [days].
Symptoms are recorded during telephone interviews at baseline and at weeks 2, 4 and 6 in an electronic case report form and as patient-reported outcomes by paper questionnaires (SF-36 V.1.0, FACIT-F, 4-week daily symptom questionnaire).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start1 Feb 2021
- Primary completion27 Jul 2022
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Schreiber, MD, Principal investigator, University Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751604
- Sponsor's protocol ID
- A 107/20
- Acronym
- COVit-2
- Status last verified
- Nov 2022
- First submitted
- 3 Feb 2021
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of the Nutritional Status Regarding Nicotinamide (Vitamin B3) and the Disease Course of COVID-19
- ClinicalTrials.gov ID
- NCT04751604
- Acronym / sponsor ID
- COVit-2 / A 107/20
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 27 Jul 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 12 Feb 2021 (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.
Based on the literature, it seems likely that a nutritional intervention with nicotinamide (a form of vitamin B3) can support the therapy of SARS-CoV-2 infection (COVID-19). A pilot phase of the COVit trial showed an effect of nicotinamide on the time to complete resolution of COVID-19 symptoms. In addition, diarrhoea is a common symptom of COVID-19. Therefore, in a second part of the study, 420 symptomatic patients each with confirmed SARS-CoV-2 infection are to take 1,000 mg nicotinamide (500 mg conventional nicotinamide and 500 mg nicotinamide released in a controlled manner in the intestine) or corresponding placebos per day in a blinded fashion for 4 weeks. The primary endpoint of the trial is the occurrence of individual COVID-19 symptoms over time (primary analysis time point: week 2). Secondary endpoints focus on the severity of COVID-19 symptoms, the post-COVID-19 syndrome (PCS), anti-SARS-CoV-2 antibody levels, and the time to resolution of individual or all symptoms. Exploratory endpoints include the WHO clinical scale for COVID-19, development of severe COVID-19, fatigue, quality of life and biomarkers. Patients are approached after positive testing and give their informed consent online. After randomised distribution of the trial supplements, patients are interviewed by telephone about their disease course at baseline (week 0), week 2, week 4, week 6 and after 6 months. Stool samples are collected from up to 400 patients at the same timepoints. In addition to blood count and standard blood profile, various inflammatory markers and the metabolome, in particular tryptophan metabolism, are examined in the blood of up to 20 selected patients. In these patients, the viral strain is determined by sequencing from nasopharyngeal swabs. In selected patients, short-term pharmacokinetics of nicotinamide, nicotinic acid and nicotinuric acid as well as of metabolites of nicotinamide and tryptophan are investigated. In the stool, changes in the microbiome (in 100-300 patients) as well as metagenome and metabolome (in a subgroup) will be analysed. The study is expected to produce rapid results on whether nicotinamide supplementation can alleviate the disease course of COVID-19. Moreover, a follow-up interview, a smell test, a cognitive test and anti-SARS-CoV-2 antibody levels after at least 6 months will be used to investigate whether the supplementation has any influence on PCS as well as the immune reaction against SARS-CoV-2.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicotinamide | Experimental | Dietary Supplement: NicotinamideDaily oral administration of 1,000 mg nicotinamide [1x 500-mg conventional nicotinamide tablet and 1x 500-mg tablet with controlled-ileocolonic-release nicotinamide (CICR-NAM)] for 4 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboDaily oral administration of 2 matching placebo tablets for 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient is of age (at least 18 years).
- SARS-CoV-2 infection confirmed by laboratory findings; the positive test must not date back more than 7 days.
- Relevant infection symptoms, e.g. in the respiratory or gastrointestinal tract.
- The patient has been able to give written consent via a website before any trial procedure is performed and can comply with the trial-dependent prerequisites and requirements.
Key exclusion criteria (3 listed)
- Current participation in another trial.
- Pregnancy or breastfeeding.
- Vaccination against SARS-CoV-2.
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 |
|---|---|---|
| NicotinamideDaily oral administration of 1,000 mg nicotinamide [1x 500-mg conventional nicotinamide tablet and 1x 500-mg tablet with controlled-ileocolonic-release nicotinamide (CICR-NAM)] for 4 weeks | Dietary supplement | Nicotinamide |
| PlaceboDaily oral administration of 2 matching placebo tablets for 4 weeks | Dietary supplement | Placebo |
Primary outcome
Frequencies of individual COVID-19 symptoms at week 0, week 2 (primary time of analysis), week 4 and week 6 as well as after 6 months.
Time frame: Through study completion, up to 6 months
A broad range of symptoms is recorded during telephone interviews at baseline, at weeks 2, 4 and 6 and after 6 months in an electronic case report form. Key symptoms include performance drop / limited physical capacity, the ability to perform normal activities, cough and fatigue. A complaint scale for lower respiratory tract infections is queried with the aspects of cough, mucus production, shortness of breath, sleep, ability to perform normal activities, and general feeling of illness, with gradations from 0 = normal to 6 = maximally poor. In addition, patient-reported outcomes by paper questionnaires are recorded: SF-36 V.1.0 and FACIT-F are completed in parallel to the telephone interviews from baseline to through study completion (up to 6 months); a subgroup of patients records daily changes in symptom occurrence and severity during the time of dietary supplementation (4 weeks), with gradations from 0 = not at all to 4 = intolerable.
8 secondary outcomes
Severity of individual COVID-19 symptoms at week 0, week 2 (primary time of analysis), week 4 and week 6 as well as after 6 months.
Time frame: Through study completion, up to 6 months
Frequency and severity of symptoms characteristic of post-COVID-19 syndrome (at month 6).
Time frame: 6 months
3. Levels of antibodies directed against the N protein or S protein of SARS-CoV-2 after at least 6 months (anti-S protein stratified for presence and type of booster vaccination).
Time frame: 6 months
Frequency of complete symptom resolution after 2 weeks of dietary supplementation.
Time frame: 2 weeks
Frequency of complete symptom resolution after 4 weeks of dietary supplementation.
Time frame: 4 weeks
Frequency of complete symptom resolution after 6 weeks (4 weeks of dietary supplementation and 2 weeks follow-up).
Time frame: 6 weeks
Time from diagnosis resolution of individual symptoms [days].
Time frame: 6 weeks
Time from diagnosis to complete symptom resolution [days].
Time frame: 6 weeks
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 8 Nov 2022.
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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.
Stefan Schreiber, MD principal investigator
University Hospital Schleswig-Holstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotinamide in people with COVID-19, run by University Hospital Schleswig-Holstein at 1 site in Germany.
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 4 inclusion and 3 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 8 Nov 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 Germany. 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?
Frequencies of individual COVID-19 symptoms at week 0, week 2 (primary time of analysis), week 4 and week 6 as well as after 6 months. (time frame: Through study completion, up to 6 months). 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 8 Nov 2022.