Status:
COMPLETED
Covid-19, Hospitalized, PatIents, Nasafytol
Lead Sponsor:
Tilman S.A.
Collaborating Sponsors:
Artialis
Conditions:
Coronavirus Infection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 para...
Detailed Description
50 patients (25 per arm) infected with COVID-19 and hospitalized (depending on the progress of the pandemic and therefore the presence of COVID-19 patients, this number could reach 100 (50 per arm)). ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
February 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT04844658
Start Date
February 17 2021
End Date
March 31 2022
Last Update
October 13 2022
Active Locations (1)
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1
Delta Hospital
Brussels, Belgium, 1160