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

General Administration of Military Health, Tunisia

Status and phase: Completed; Phase 3

Conditions: COVID-19 Pneumonia

Treatments: Drug: NANOS1 , argent colloïdal ,

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT05822180

COVID NANO S1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 116 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participants are hospitalized in a COVID unity or outpatient follow-up by the investigator

2. 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.

3. 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...

4. Present an oxygen saturation patients with SpO2 > 94% at room air

5. 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.

6. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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116 participants in 2 patient groups, including a placebo group

A bras actif

Experimental group

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).

Treatment:

Drug: NANOS1 , argent colloïdal ,

B bras controle

Placebo Comparator group

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).

Treatment:

Drug: NANOS1 , argent colloïdal ,