COVNANOS1: Evaluation of the Efficacy and Safety of Nano-S1
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: A bras actif 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). |
Drug: NANOS1 , argent colloïdal ,
orally, during 5 day
|
| Placebo Comparator: B bras controle 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). |
Drug: NANOS1 , argent colloïdal ,
orally, during 5 day
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- Negativation of the RT- PCR [DAY 14]
Negativation of the RT- PCR after 14 days since the beginning of the disease. of the randomization
- Tolerance [DAY 14, DAY 30]
Évaluate the tolerance of the study product (Nano-S1) versus placebo on the occurrence of adverse events
- 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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Agili Faida | Tunis | Tunisia | 2034 |
Sponsors and Collaborators
- General Administration of Military Health, Tunisia
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- COVID NANO S1