Improvement of the Nutritional Status Regarding Nicotinamide (Vitamin B3) and the Disease Course of COVID-19

NCT ID: NCT04751604

Last Updated: 2022-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 900 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-10-20

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Nicotinamide

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

Group Type: EXPERIMENTAL

Nicotinamide

Intervention Type: DIETARY_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

Placebo

Daily oral administration of 2 matching placebo tablets for 4 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Daily oral administration of 2 matching placebo tablets for 4 weeks

Interventions

Nicotinamide

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Daily oral administration of 2 matching placebo tablets for 4 weeks

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Current participation in another trial.
• Pregnancy or breastfeeding.
• Vaccination against SARS-CoV-2.

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

Sponsors

University Hospital Schleswig-Holstein

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefan Schreiber, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Schleswig-Holstein

Locations

University Hospital Schleswig-Holstein

Kiel, Schleswig-Holstein, Germany

Countries

Germany

Other Identifiers

A 107/20

Identifier Type: -

Identifier Source: org_study_id