Covid-19, Hospitalized, PatIents, Nasafytol

Coronavirus Infection Clinical Trial

Official title:

A Comparative Randomized Clinical Study on Covid-19 Positive Hospitalized Patients Supplemented With NASAFYTOL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04844658
• Other study ID #: CHOPIN
• Status: Completed
• Phase: N/A
• Start date: February 17, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: October 2022
• Source: Tilman S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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)). The first ten sentinel patients will be monitored at the safety level before enrolling the rest of the participants.

The effect and safety of NASAFYTOL® will be evaluated using the following outcome measures:

1. Improvement of clinical condition of the patient defined by the COVID-19 WHO ordinal Outcomes score. This scale reflects a range from uninfected to dead, where 0 is "no clinical or virological evidence of infection", 1 is "no limitation of activities", 2 is "limitation of activities", 3 is "hospitalized, no oxygen therapy", 4 is "oxygen by mask or nasal prongs", 5 is "non-invasive ventilation or high-flow oxygen", 6 is "intubation and mechanical ventilation", 7 is "ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)", and 8 is "death".

• Time to a 1-point decrease

• Score at 14 days (or at hospital leave if <14 days) post randomization

2. Duration (days) of hospitalization

3. In-hospital mortality

4. Temperature (fever):

• Time to resolution of fever for at least 48 hours without antipyretics for 48 hours
• Defined as ≤36.6°C (axilla), ≤37.2°C (oral) or ≤37.8°C (rectal or tympanic)

• Proportion of participants with normalization at day 14 (or at hospital leave if <14 days)

5. Need of oxygen therapy

6. Tolerance as defined by the Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)

7. Compliance using the pill count

8. Blood test:

• C-reactive proteins : Time to halving of (or achieve normal ) CRP levels compared to peak value during trial

• Hematological values (included Lymphocyte Count) and others routine laboratory parameters (LDH, albumin, etc.): Time to normalization

• Vitamin D serum concentration: comparison of concentration between inclusion and end of trial and between the 2 arms.

Optional outcome measures will be perform if data is available from routine practice:

9. Blood tests between inclusion and end of trial

10. Radiological response - Thoracic CT scan or Chest XR

11. Oxygenation PaO2 (partial pressure of oxygen) / FiO2 (fraction of inspired oxygen, FiO2) ratio (or P/F ratio) :

• Time to improvement (TBD) in oxygenation for at least 48 hours

• Proportion of participants with normalization at day 14 (or at hospital leave if <14 days)

12. Time until negative RT-PCR

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: March 31, 2022
• Est. primary completion date: October 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections

Intervention

Dietary Supplement:
• NASAFYTOL®
Dietary supplement presented as green soft gel capsules of 1008 mg, containing a bioactive mixture of turmeric extract or curcumin, natural quercetin from Sophora japonica L. and vitamin D3.
• FULTIUM® -D3 800
Vitamin D , FULTIUM® - D3 800 is a blue soft capsule that contains 800 UI (20 µg) of D3 vitamin (cholecalciferol).

Drug:
• Strandard of care treatment
Strandard of care treatment for Covid-19 infection

Locations

Country	Name	City	State
Belgium	Delta Hospital	Brussels

Sponsors (2)

Lead Sponsor	Collaborator
Tilman S.A.	Artialis

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Radiological response (exploratory)	Thoracic CT scan or Chest XR if available	day 14
Other	Oxygenation	Time to improvement in oxygenation ratio for at least 48 hours. PaO2 (partial pressure of oxygen) / FiO2 (fraction of inspired oxygen, FiO2) ratio (or P/F ratio)	day 14
Other	Oxygenation	Proportion of participants with ratio normalization at day 14 (or at hospital leave if <14 days) PaO2 (partial pressure of oxygen) / FiO2 (fraction of inspired oxygen, FiO2) ratio (or P/F ratio)	day 14
Primary	Improvement of the patient's clinical condition based on the WHO ordinal outcomes score	Time to a 1-point decrease on the ordinal scale. The ordinal scale reflects a range score from uninfected to dead, where 0 is "no clinical or virological evidence of infection", 1 is "no limitation of activities", 2 is "limitation of activities", 3 is "hospitalized, no oxygen therapy", 4 is "oxygen by mask or nasal prongs", 5 is "non-invasive ventilation or high-flow oxygen", 6 is "intubation and mechanical ventilation", 7 is "ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)", and 8 is "death".	day 14
Primary	Improvement of the patient's clinical condition based on the WHO ordinal outcomes score	Ordinal score at 14 days (or at hospital leave if <14 days) post randomization. The ordinal scale reflects a range score from uninfected to dead, where 0 is "no clinical or virological evidence of infection", 1 is "no limitation of activities", 2 is "limitation of activities", 3 is "hospitalized, no oxygen therapy", 4 is "oxygen by mask or nasal prongs", 5 is "non-invasive ventilation or high-flow oxygen", 6 is "intubation and mechanical ventilation", 7 is "ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)", and 8 is "death".	day 14
Primary	Duration of hospitalization	Number of days hospitalization	day 14
Primary	In-hospital mortality	Number of deads	day 14
Primary	Temperature (fever)	Time to resolution of fever for at least 48 hours without antipyretics for 48 hours - Defined as =36.6°C (axilla), =37.2°C (oral) or =37.8°C (rectal or tympanic)	day 14
Primary	Temperature (fever)	Proportion of participants with normalization at day 14 (or at hospital leave if <14 days)	day 14
Primary	Need of oxygen therapy	Proportion of participants with oxygen therapy	day 14
Primary	Tolerance as defined by the Incidence of Adverse Events (AE)	Numbers of Adverse Events	day 14
Primary	Tolerance as defined by the incident of Serious Adverse Events (SAE)	Numbers of Serious Adverse Events	day 14
Primary	Compliance using the pill count	Numbers of Pill count taken by the patient	day 14
Primary	Blood test	C-reactive proteins : Time to halving of (or achieve normal ) CRP levels compared to peak value during trial	day 14
Primary	Blood test	Hematological values (included Lymphocyte Count) and others routine laboratory parameters (LDH, albumin, etc.): Time to normalization	day 14
Primary	Blood test	Vitamin D serum concentration: comparison of concentration between inclusion and end of trial and between the 2 arms.	day 14