Covid-19, Hospitalized, PatIents, Nasafytol

NCT04844658 | Completed DMC

• 1 other identifier: CHOPIN
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (13)

• 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

• 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

• Duration of hospitalization

  Number of days hospitalization

  day 14

• In-hospital mortality

  Number of deads

  day 14

• 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

• Temperature (fever)

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

  day 14

• Need of oxygen therapy

  Proportion of participants with oxygen therapy

  day 14

• Tolerance as defined by the Incidence of Adverse Events (AE)

  Numbers of Adverse Events

  day 14

• Tolerance as defined by the incident of Serious Adverse Events (SAE)

  Numbers of Serious Adverse Events

  day 14

• Compliance using the pill count

  Numbers of Pill count taken by the patient

  day 14

• Blood test

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

  day 14

• Blood test

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

  day 14

• Blood test

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

  day 14

Other Outcomes (3)

• Radiological response (exploratory)

  day 14

• Oxygenation

  day 14

• Oxygenation

  day 14

Study Arms (2)

standard treatment + NASAFYTOL®

EXPERIMENTAL

Minimum 25 patients will receive NASAFYTOL® as a supportive supplementation to standard treatment of hospitalized patients infected with COVID-19. For each patient, 8 capsules of NASAFYTOL® taken orally per day (4 capsules in the morning and 4 capsules in the evening before meal ,with a full glass of water. ) in support of the standard COVID-19 treatment in force in the hospital from the day after the randomization (day1) and during the period of hospitalization and maximum for 14 days

Dietary Supplement: NASAFYTOL®; Drug: Strandard of care treatment

standard treatment + FULTIUM® - D3 800

ACTIVE COMPARATOR

Minimum 25 patients will receive vitamin D , FULTIUM® - D3 800 as a supportive supplementation to standard treatment of hospitalized patients infected with COVID-19. For each patient,1 capsule of Vitamin D taken orally per day (1 capsule in the morning) in support of the standard COVID-19 treatment in force in the hospital from the day after the randomization (day1) and for the duration of the hospitalization and maximum for 14 days

Dietary Supplement: FULTIUM® -D3 800; Drug: Strandard of care treatment

Interventions

NASAFYTOL® DIETARY_SUPPLEMENT

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.

standard treatment + NASAFYTOL®

FULTIUM® -D3 800 DIETARY_SUPPLEMENT

Vitamin D , FULTIUM® - D3 800 is a blue soft capsule that contains 800 UI (20 µg) of D3 vitamin (cholecalciferol).

standard treatment + FULTIUM® - D3 800

Strandard of care treatment DRUG

Strandard of care treatment for Covid-19 infection

standard treatment + FULTIUM® - D3 800; standard treatment + NASAFYTOL®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tilman S.A.: lead
• Artialis: collaborator

Study Sites (1)

Delta Hospital

Brussels, 1160, Belgium

Location

Related Publications (1)

• Gerain J, Uebelhoer M, Costes B, Herman J, Pietri S, Donneau AF, Monseur J, Henrotin Y. NASAFYTOL(R) supplementation in adults hospitalized with COVID-19 infection: results from an exploratory open-label randomized controlled trial. Front Nutr. 2023 Jun 22;10:1137407. doi: 10.3389/fnut.2023.1137407. eCollection 2023.

  PMID: 37426178 DERIVED

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 14, 2021
• Study Start: February 17, 2021
• Primary Completion: October 29, 2021
• Study Completion: March 31, 2022
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)