Evaluation of the Efficacy and Safety of Nano-S1

NCT05822180 | Completed Phase 3 DMC

• 1 other identifier: COVID NANO S1
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Pneumonia

Keywords

ARGENT COLLOIDAL

Outcome Measures

Primary Outcomes (1)

• 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)

  14DAY

Secondary Outcomes (5)

• Disappearance of clinical signs

  3 days

• Viral load Ct value

  admission ,DAY6, DAY14

• Negativation of the RT- PCR

  DAY 14

• Tolerance

  DAY 14, DAY 30

• Systemic passage

  DAY 30

Study Arms (2)

A bras actif

EXPERIMENTAL

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).

Drug: NANOS1 , argent colloïdal ,

B bras controle

PLACEBO COMPARATOR

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).

Drug: NANOS1 , argent colloïdal ,

Interventions

NANOS1 , argent colloïdal , DRUG

orally, during 5 day

A bras actif; B bras controle

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Non observance.Non-compliant patient With drawal of Consent. Patient who refuses blood samples.

Sponsors & Collaborators

• General Administration of Military Health, Tunisia: lead

Study Sites (1)

Agili Faida

Tunis, 2034, Tunisia

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: April 20, 2023
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: February 20, 2022
• Last Updated: April 20, 2023

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)