Evaluation of the Efficacy and Safety of Nano-S1

COVID-19 Pneumonia Clinical Trial

— COVNANOS1  

Official title:

Evaluation of the Efficacy and Safety of Nano-S1 in Adult Patients Infected With SARS-Cov-2: "COVID Nano-S1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05822180
• Other study ID #: COVID NANO S1
• Status: Completed
• Phase: Phase 3
• Start date: January 1, 2021
• Est. completion date: February 20, 2022

Study information

• Verified date: January 2022
• Source: General Administration of Military Health, Tunisia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: February 20, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19 Pneumonia
• Pneumonia

Intervention

Drug:
• NANOS1 , argent colloïdal ,
orally, during 5 day

Locations

Country	Name	City	State
Tunisia	Agili Faida	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
General Administration of Military Health, Tunisia

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical evolution	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)	14DAY
Secondary	Disappearance of clinical signs	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	3 days
Secondary	Viral load Ct value	Evaluate the significative decrease of viral load between DAY 0 and DAY 6, and between DAY6 and DAY14 by the variation of CtT values.	admission ,DAY6, DAY14
Secondary	Negativation of the RT- PCR	Negativation of the RT- PCR after 14 days since the beginning of the disease. of the randomization	DAY 14
Secondary	Tolerance	Évaluate the tolerance of the study product (Nano-S1) versus placebo on the occurrence of adverse events	DAY 14, DAY 30
Secondary	Systemic passage	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.	DAY 30