A Comparative Randomized Clinical Study on Covid-19 Positive Hospitalized Patients Supplemented With NASAFYTOL
Abstract
The objective of this study is to evaluate the effect and safety of NASAFYTOL® on COVID-19 positive hospitalized patients as a supportive supplementation to standard-of-care in improving clinical parameters safely during hospital admission (maximum 14 days).
The study is a standard-of-care comparative, open, parallel two-arms and randomized trial in 50 adult patients positive to COVID-19 infection and hospitalized. It will be monocentric but may be extended to several investigation sites (multicentric) depending on the evolution of the epidemic within the hospitals.
Conditions: Coronavirus Infection.
Primary outcome: Improvement of the patient's clinical condition based on the WHO ordinal outcomes score; Improvement of the patient's clinical condition based on the WHO ordinal outcomes score; Duration of hospitalization; In-hospital mortality; Temperature (fever); Temperature (fever); Need of oxygen therapy; Tolerance as defined by the Incidence of Adverse Events (AE); Tolerance as defined by the incident of Serious Adverse Events (SAE); Compliance using the pill count; Blood test; Blood test; Blood test.
Enrollment: 51 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 51 participants or records.
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