Evaluation of the Efficacy and Safety of Nano-S1

Phase 3

Completed

• Conditions: COVID-19 Pneumonia
• Interventions: Drug: NANOS1 , argent colloïdal ,

• Registration Number: NCT05822180
• Lead Sponsor: General Administration of Military Health, Tunisia

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.

Study Timeline

• Study Start: 2021-01-01
• Status Verified: 2022-01
• Primary Completion: 2022-01-01
• Study Completion: 2022-02-20
• Study First Submitted: 2023-04-19
• Study First Submitted QC: 2023-04-19
• Last Update Submitted: 2023-04-19
• Study First Posted: 2023-04-20
• Last Update Posted: 2023-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A bras actif	NANOS1 , argent colloïdal ,	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).
B bras controle	NANOS1 , argent colloïdal ,	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).

Primary Outcome Measures

Name	Time	Method
Clinical evolution	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 Outcome Measures

Name	Time	Method
Negativation of the RT- PCR	DAY 14	Negativation of the RT- PCR after 14 days since the beginning of the disease. of the randomization
Systemic passage	DAY 30	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.
Disappearance of clinical signs	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
Viral load Ct value	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.
Tolerance	DAY 14, DAY 30	Évaluate the tolerance of the study product (Nano-S1) versus placebo on the occurrence of adverse events

Trial Locations

Locations (1)

Agili Faida; 🇹🇳 Tunis, Tunisia