Trial NCT04573153
Publication Altay O, medRxiv, 2020 (preprint)
Dates: 2020-07-15 to 2020-09-18
Funding: Private (This work was supported by Knut and Alice Wallenberg Foundation. ChromaDex (Irvine, CA, USA) for providing NR (nicotinamide riboside).)
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 |
Exclusion criteria | Patients who has partial oxygen saturation below 90% or with severe clinical status requiring admission to critical care unit |
Interventions | |
Treatment
Combined metabolic cofactor supplementation (39.26 g/day (L-Carnitine tartrate, 7.46 g/day ) Co-Intervention: Standard care Duration : 14 days |
|
Control
Placebo (lactose 60 mL) Duration : 14 days | |
Participants | |
Randomized 93 participants (n1=71 / n2= 22) | |
Characteristics of participants N=93 Mean age : NR 37 males Severity : Mild: n=93 / Moderate: n=0/ Severe: n=0 Critical: n=0 | |
Primary outcome | |
In the register No | |
In the report The primary outcome was the time to recovery (ending of all symptoms) | |
Documents avalaible |
Protocol NR Statistical plan NR Data-sharing stated Yes |
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 | In addition to the pre-print study report, the study registration and supplementary materials were used in data extraction and assessment of risk of bias. Neither study protocol nor statistical analysis plan was available. Completed single-center phase II study with 100 patients; the research will continue as a multi-center Phase III study with a further 300 patients. There were some changes in the primary outcome between the trial registration and the reported study, but the authors are transparent about this and report that all protocol amendments were authorized and approved by the sponsor, the institutional review board or independent ethics committee, and the pertinent regulatory authorities. The authors' descriptions of blinding in the study are unclear. The study is described as open-label in the report and registration, and in the limitations authors report “the trial was not blinded”. But they also report that the trial is placebo-controlled and that “Except the investigator, all other clinical staff involved in the daily surveying of the study participants blinded to whether the patients were receiving placebo or active. The patients were also unaware if they were receiving active or placebo.” |