Covid-19, Hospitalized, PatIents, Nasafytol

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tilman S.A.
• Collaborator: Artialis

Criteria

Inclusion Criteria:

• Adult ≥ 18 years of age at the time of inclusion in the study;

• Recently hospitalized patients in whom SARS CoV-2 infection has been laboratory confirmed by RT-PCR or other commercial or public health test on any sample.

• 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).