ICD: U07.1: SARS-CoV-2 U07.1
Conditions
Interventions
Group 1: Nicotinamide, 1,000 mg/day p.o. (one each of 500-mg conventional and delayed-release nicotinamide tablets), for 4 weeks
Group 2: Placebo, p.o. (2 tablets), for 4 weeks
Sponsors
Klinik für Innere Medizin I (UKSH Campus Kiel)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: Current participation in another trial. Pregnancy or breastfeeding. Vaccination against SARS-CoV-2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 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. 2. Occurrence and severity of symptoms that are characteristic for PCS (at month 6). 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). 4. Complete resolution of symptoms after 2 weeks. 5. Complete resolution of symptoms after 4 weeks. 6. Complete resolution of symptoms after 6 weeks. 7. Time from diagnosis to resolution of individual symptoms (in days, up to 6 weeks). 8. Time from diagnosis to complete resolution of symptoms (in days, up to 6 weeks). Exploratory endpoints include the WHO COVID-19 Ordinal Scale for Clinical Improvement, the frequency of severe COVID-19, comparisons between findings from the pilot phase and the second part of the trial, changes in fatigue and quality of life and, in selected patients, changes in blood levels of tryptophan and its metabolites, changes in inflammatory markers, changes in blood cell counts and standard blood profiles, changes in the blood metabolome, the SARS-CoV-2 strain, changes in stool microbiome, metagenome and metabolome as well as the pharmacokinetics. | — |
Countries
Germany
Contacts
Public ContactStefan Schreiber
Klinik für Innere Medizin I, UKSH Campus Kiel
Outcome results
None listed