The research company Tilman S.A is conducting the clinical trial to evaluate the efficacy and safety of NASAFYTOL® on COVID-19 positive hospitalized patients.

A Coronavirus Infection clinical trial begins in Belgium.

The objective of this study is to evaluate the efficacy and safety of NASAFYTOL® on COVID-19 positive hospitalized patients as a supportive treatment 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.

It is planned to include 50 participants.

Actual study start date is February 17, 2021. The researchers expect to complete the study by September 1, 2021.

One primary outcome measure is Tolerance as defined by the incident of Serious Adverse Events (SAE), Numbers of Serious Adverse Events.

The following patients may be included into the study: Adult ≥ 18 years of age at the time of inclusion in the study; - Has laboratory-confirmed SARS-CoV-2 infection as determined by RT-PCR, or other commercial or public health assay in any specimen as diagnosed within 72 hours prior to randomization; - Severity of 3-4-5 according to the WHO 7-point ordinal scale (3: hospitalized, no oxygen therapy; 4: hospitalized, oxygen by mask or nasal prongs; 5:non-invasive ventilation or high-flow oxygen); - Subject (or authorized legal representative) who can provide oral or written informed consent before beginning any study procedure; - Understand and agree to abide by the study procedures. Exclusion Criteria: - Contra-indication to NASAFYTOL® or constituents (incl. Vit D): hypersensitivity or allergy to product components; - Swallowing disorder or inability to take oral caps; - Presence of comorbidities that imply a poor prognosis (according to clinical judgment); - Pregnancy or breastfeeding women; If patient is a female of childbearing potential, patient must use an effective means of birth control (oral, intravaginal or transdermal oestrogen-progestogen combined hormonal contraceptives or intrauterine devices or sexual abstinence); - Serious or active bacterial infections or documented sepsis by pathogens other than SARS-CoV-2; - Patients participating in clinical trials of other products; Patients presenting acute impairment of renal function or nephrolithiasis; ALT/AST> 5 times the normal limit, or Neutropenia (Absolute neutrophil count < 500/uL), or Thrombocytopenia (Platelets < 50,000/uL) is one of the inclusion criteria.

Among the exclusion criteria are:

  • Contra-indication to NASAFYTOL® or constituents (incl. Vit D): hypersensitivity or allergy to product components; - Swallowing disorder or inability to take oral caps; - Presence of comorbidities that imply a poor prognosis (according to clinical judgment); - Pregnancy or breastfeeding women; If patient is a female of childbearing potential, patient must use an effective means of birth control (oral, intravaginal or transdermal oestrogen-progestogen combined hormonal contraceptives or intrauterine devices or sexual abstinence); - Serious or active bacterial infections or documented sepsis by pathogens other than SARS-CoV-2; - Patients participating in clinical trials of other products; Patients presenting acute impairment of renal function or nephrolithiasis; ALT/AST> 5 times the normal limit, or Neutropenia (Absolute neutrophil count < 500/uL), or Thrombocytopenia (Platelets < 50,000/uL).

The location of the study is Brussels, Belgium (further details can be found here: https://ichgcp.net/clinical-trials-registry/NCT04844658

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