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Evaluation of the Efficacy and Safety of Nano-S1 (COVNANOS1)

Primary Purpose

COVID-19 Pneumonia

Status
Completed
Phase
Phase 3
Locations
Tunisia
Study Type
Interventional
Intervention
NANOS1 , argent colloïdal ,
Sponsored by
General Administration of Military Health, Tunisia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 Pneumonia focused on measuring ARGENT COLLOIDAL

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants are hospitalized in a COVID unity or outpatient follow-up by the investigator Participants who have positive SARS-CoV-2 test result and the onset of symptoms of COVID-19 ≤7 days prior to randomization, Not exceed the 7th day since the beginning of disease symptoms; and the randomization's day. Present at least one of these symptoms: Participants who have one or more mild or moderate COVID-19 symptoms: Fever, general signs such as: headaches, asthenia, myalgia, arthralgia, etc... ENT signs such as: Sore throat, anosmia, agueusia, hypoacusis, deafness, etc... Digestive signs such as: diarrhea, vomiting, abdominal pain, etc... Respiratory signs such as: dyspnea, cough, etc... And cutaneous signs such as: skin rash, livedo, etc... Present an oxygen saturation patients with SpO2 > 94% at room air Present at least one of these risk factors: Participants who satisfy one or more than one of the following high risks for progression to severe COVID-19, including death: Age 65 years old Or -Age between 18 and 64 years old with at least one of these risk factors: Obesity (BMI> 30 kg/m2),and/or diabetes under treatment and/or cardiovascular disease (including hypertension and stable angina) high blood pressure and/or Chronic obstructive pulmonary disease (COPD) disease and/or asthma and/or Neoplasia (solid tumour; hematological malignancy) neoplasia, and/or a blood disease and/or heart failure and/or chronic renal failure (Cl creat> 30Mml/min) and/or unstabe angina and/or autoimmune disease. Have signed the informed consent to participate in this trial. Exclusion Criteria: Non observance.Non-compliant patient With drawal of Consent. Patient who refuses blood samples.

Sites / Locations

  • Agili Faida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A bras actif

B bras controle

Arm Description

The experimental arm has received the Nanos product orally with a dose of 30mL, 3 times per day and away from meals (2 hours after a meal or on an empty stomach).

The placebo arm has received the Nanos product orally with a dose of 30mL, 3 times per day and away from meals (2 hours after a meal or on an empty stomach).

Outcomes

Primary Outcome Measures

Clinical evolution
The evolution clinical state of evaluated patient clinical state after 14 days since the beginning of the disease is made with " a 8-point ordinal scale " (WHO Rd Blue print novel Coronavirus / COVID-19 Therapeutic Trial Synopsis / 18 February 2020)

Secondary Outcome Measures

Disappearance of clinical signs
Disappearance of clinical signs (functional and physical) reported and confirmed at the study inclusion visit (Visit 1). The deadline of disappearance: - Less than or equal to 3 days
Viral load Ct value
Evaluate the significative decrease of viral load between DAY 0 and DAY 6, and between DAY6 and DAY14 by the variation of CtT values.
Negativation of the RT- PCR
Negativation of the RT- PCR after 14 days since the beginning of the disease. of the randomization
Tolerance
Évaluate the tolerance of the study product (Nano-S1) versus placebo on the occurrence of adverse events
Systemic passage
6. Evaluate the systemic passage of the product of the study by the assay in the blood on J1 (before taking PI ID), on J6 (on the last day) and on DAY 30 in the two study groups.

Full Information

First Posted
April 19, 2023
Last Updated
April 19, 2023
Sponsor
General Administration of Military Health, Tunisia
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1. Study Identification

Unique Protocol Identification Number
NCT05822180
Brief Title
Evaluation of the Efficacy and Safety of Nano-S1
Acronym
COVNANOS1
Official Title
Evaluation of the Efficacy and Safety of Nano-S1 in Adult Patients Infected With SARS-Cov-2: "COVID Nano-S1
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
February 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
General Administration of Military Health, Tunisia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study aims to assess the efficacy of the efficacy and safety of investigational drug (NanoS) in patients with mild to moderate COVID-19 at high risk for progression to severe COVID-19, including death.
Detailed Description
We conducted a prospective randomized double-blind clinical trial over five months to determine the efficacy of NanoS compared to placebo. The effectiveness of treatment was measured by the significant decline in the number of cases of covid-19 infection and/or a decrease in the viral load determined by SARS-CoV-2 cycle threshold (Ct) value using RT-PCRs test.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pneumonia
Keywords
ARGENT COLLOIDAL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A bras actif
Arm Type
Experimental
Arm Description
The experimental arm has received the Nanos product orally with a dose of 30mL, 3 times per day and away from meals (2 hours after a meal or on an empty stomach).
Arm Title
B bras controle
Arm Type
Placebo Comparator
Arm Description
The placebo arm has received the Nanos product orally with a dose of 30mL, 3 times per day and away from meals (2 hours after a meal or on an empty stomach).
Intervention Type
Drug
Intervention Name(s)
NANOS1 , argent colloïdal ,
Intervention Description
orally, during 5 day
Primary Outcome Measure Information:
Title
Clinical evolution
Description
The evolution clinical state of evaluated patient clinical state after 14 days since the beginning of the disease is made with " a 8-point ordinal scale " (WHO Rd Blue print novel Coronavirus / COVID-19 Therapeutic Trial Synopsis / 18 February 2020)
Time Frame
14DAY
Secondary Outcome Measure Information:
Title
Disappearance of clinical signs
Description
Disappearance of clinical signs (functional and physical) reported and confirmed at the study inclusion visit (Visit 1). The deadline of disappearance: - Less than or equal to 3 days
Time Frame
3 days
Title
Viral load Ct value
Description
Evaluate the significative decrease of viral load between DAY 0 and DAY 6, and between DAY6 and DAY14 by the variation of CtT values.
Time Frame
admission ,DAY6, DAY14
Title
Negativation of the RT- PCR
Description
Negativation of the RT- PCR after 14 days since the beginning of the disease. of the randomization
Time Frame
DAY 14
Title
Tolerance
Description
Évaluate the tolerance of the study product (Nano-S1) versus placebo on the occurrence of adverse events
Time Frame
DAY 14, DAY 30
Title
Systemic passage
Description
6. Evaluate the systemic passage of the product of the study by the assay in the blood on J1 (before taking PI ID), on J6 (on the last day) and on DAY 30 in the two study groups.
Time Frame
DAY 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants are hospitalized in a COVID unity or outpatient follow-up by the investigator Participants who have positive SARS-CoV-2 test result and the onset of symptoms of COVID-19 ≤7 days prior to randomization, Not exceed the 7th day since the beginning of disease symptoms; and the randomization's day. Present at least one of these symptoms: Participants who have one or more mild or moderate COVID-19 symptoms: Fever, general signs such as: headaches, asthenia, myalgia, arthralgia, etc... ENT signs such as: Sore throat, anosmia, agueusia, hypoacusis, deafness, etc... Digestive signs such as: diarrhea, vomiting, abdominal pain, etc... Respiratory signs such as: dyspnea, cough, etc... And cutaneous signs such as: skin rash, livedo, etc... Present an oxygen saturation patients with SpO2 > 94% at room air Present at least one of these risk factors: Participants who satisfy one or more than one of the following high risks for progression to severe COVID-19, including death: Age 65 years old Or -Age between 18 and 64 years old with at least one of these risk factors: Obesity (BMI> 30 kg/m2),and/or diabetes under treatment and/or cardiovascular disease (including hypertension and stable angina) high blood pressure and/or Chronic obstructive pulmonary disease (COPD) disease and/or asthma and/or Neoplasia (solid tumour; hematological malignancy) neoplasia, and/or a blood disease and/or heart failure and/or chronic renal failure (Cl creat> 30Mml/min) and/or unstabe angina and/or autoimmune disease. Have signed the informed consent to participate in this trial. Exclusion Criteria: Non observance.Non-compliant patient With drawal of Consent. Patient who refuses blood samples.
Facility Information:
Facility Name
Agili Faida
City
Tunis
ZIP/Postal Code
2034
Country
Tunisia

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of the Efficacy and Safety of Nano-S1

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