Clinical trial NCT05822180: Evaluation of the Efficacy and Safety of Nano-S1
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: COVID-19 Pneumonia
Keywords: ARGENT COLLOIDAL
Lead sponsor: General Administration of Military Health, Tunisia
Sponsor class: NETWORK
First posted: 2023-04-20
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 \&gt; 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\&gt; 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\&gt; 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.

Primary outcomes:
measure: Clinical evolution
timeFrame: 14DAY
Secondary outcomes:
measure: Disappearance of clinical signs
timeFrame: 3 days
measure: Viral load Ct value
timeFrame: admission ,DAY6, DAY14
measure: Negativation of the RT- PCR
timeFrame: DAY 14
measure: Tolerance
timeFrame: DAY 14, DAY 30
measure: Systemic passage
timeFrame: DAY 30
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Agili Faida
Study officials:
References: