Trial NCT04573153
Publication Altay O, Adv. Sci. (2021) (published paper)
Dates: 2020-07-15 to 2020-09-18
Funding: Mixed (ScandiBio Therapeutics and Knut and Alice Wallenberg Foundation; The Plasma
Profiling Facility team at SciLifeLab; Metabolon Inc.; ChromaDex (nicotinamide riboside provision); European Union's Horizon 2020 research and innovation programme)
Conflict of interest: Yes
Methods | |
RCT Blinding: Unblinded | |
Location :
Single center / Turkey Follow-up duration (days): 14 | |
Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Treatment
CMCS 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 |
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Control
Placebo | |
Participants | |
Randomized participants : CMCS=71 Placebo=22 | |
Characteristics of participants N= 93 Mean age : NR 37 males Severity : Mild: n= 93/ Asymptomatic: n=0 Number of vaccinated participants: NR | |
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 willing stated in the publication:
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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 publication/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 phase III trial is reported in the same publication but extracted separately. 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.”
On 08th of July, 2021, this study was updated based on the published report. |