Overview

Evaluation of the Efficacy and Safety of Nano-S1

Status:
Completed
Trial end date:
2022-02-20
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
General Administration of Military Health, Tunisia
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 > 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.