Trial NCT04573153
Publication Altay O, Adv. Sci., 2021 (published paper)
Dates: 2020-07-15 to 2020-09-18
Funding: Private (ScandiBio Therapeutics and Knut and Alice Wallenberg Foundation; The Plasma
Profiling Facility team at SciLifeLab; Metabolon Inc.; ChromaDex (nicotinamide riboside provision))
Conflict of interest: Yes
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Single center / Turkey Follow-up duration (days): 14 | |
| Inclusion criteria | Patients of both genders over 18 years of age; Written informed consent obtained from the subjects prior to any procedures related to the study; Understand all procedures to be applied within the scope of the study protocol; Ambulatory patients with symptoms diagnosed with COVID-19 with real time PCR test result positivity in the last 72 hours; Patients with stable clinical course and who could be treated on an ambulatory basis. |
| Exclusion criteria | Patients who has partial oxygen saturation below 90% or with severe clinical status requiring admission to critical care unit; Inability or unwillingness to give written informed consent; Physician makes a decision that trial involvement is not in patients' best interest, or any condition that does not allow the protocol to be followed safely; Patients considered as inappropriate for this study for any reason; Active participation in another clinical study; Uncontrolled Type 1 or type 2 diabetes; Severe liver disease (e.g. Child Pugh score ≥ C, AST >5 times upper limit); Patients with known severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis; Significant cardiovascular co-morbidity (i.e. heart failure); Patients with phenylketonuria (contraindicated for NAC); Known allergy for substances used in the study; Alcohol consumption over 192 grams for men and 128 grams for women per week; Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination; Receipt of any experimental treatment for COVID-19 within the 30 days prior to the time of the screening evaluation. |
| Interventions | |
| Treatment
Combined metabolic cofactor supplementation 3.73 g L-carnitine tartrate, 2.55 g N-acetylcysteine, 1 g nicotinamide riboside chloride, and 12.35 g serine orally twice a day for 2 weeks |
|
| Control
Placebo Duration : 14 days | |
| Participants | |
| Randomized 93 participants (n1=71 / n2= 22) | |
| Characteristics of participants N=93 Mean age : NR 37 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=0 | |
| Primary outcome | |
| In the register The evaluation of clinical efficacy of the combination of metabolic cofactor supplementation and hydroxychloroquine [ Time Frame: 14 days ] | |
| In the report Time to recovery (ending of all symptoms) | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated
|
| Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
Some concerns |
| General comment |