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Completed

NCT Number: NCT05822180

Evaluation of the Efficacy and Safety of Nano-S1

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.

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Key information

Conditions

COVID-19 Pneumonia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Agili Faida

Tunis, 2034, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NANOS1 , argent colloïdal ,

Drug

orally, during 5 day

Primary outcomes

  1. Clinical evolution

    Time frame: 14DAY

    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 outcomes

  1. Disappearance of clinical signs

    Time frame: 3 days

    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

  2. Viral load Ct value

    Time frame: admission ,DAY6, DAY14

    Evaluate the significative decrease of viral load between DAY 0 and DAY 6, and between DAY6 and DAY14 by the variation of CtT values.

  3. Negativation of the RT- PCR

    Time frame: DAY 14

    Negativation of the RT- PCR after 14 days since the beginning of the disease. of the randomization

  4. Tolerance

    Time frame: DAY 14, DAY 30

    Évaluate the tolerance of the study product (Nano-S1) versus placebo on the occurrence of adverse events

  5. Systemic passage

    Time frame: DAY 30

    • 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.

Sponsors and collaborators

Lead sponsor

General Administration of Military Health, Tunisia

Network

Registry information

Official study title

Evaluation of the Efficacy and Safety of Nano-S1 in Adult Patients Infected With SARS-Cov-2: "COVID Nano-S1

Acronym: COVNANOS1

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 20, 2023
Registry last updated
Apr 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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