COVID-19 PneumoniaPhase 3COVNANOS1NCT05822180
Evaluation of the Efficacy and Safety of Nano-S1
A Phase 3 study testing NANOS1 , argent colloïdal , in people with COVID-19 Pneumonia, run by General Administration of Military Health, Tunisia at 1 site in Tunisia.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- NANOS1 , argent colloïdal ,
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Jan 2021to 20 Feb 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Non observance.Non-compliant patient With drawal of Consent. Patient who refuses blood samples.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy and Safety of Nano-S1 in Adult Patients Infected With SARS-Cov-2: "COVID Nano-S1
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.
Read the 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.
- Conditions
- COVID-19 Pneumonia
- Being tested
- NANOS1 , argent colloïdal ,
- Keywords
- ARGENT COLLOIDAL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NANOS1 , argent colloïdal ,Drug
orally, during 5 day
| Study group | Role | What they receive |
|---|---|---|
| A bras actif | Experimental | 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). Receives: Drug: NANOS1 , argent colloïdal , |
| B bras controle | Placebo comparator | 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). Receives: Drug: NANOS1 , argent colloïdal , |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 14DAY
Secondary outcomes (5)
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
Measured: 3 days
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.
Measured: admission ,DAY6, DAY14
Negativation of the RT- PCR
Negativation of the RT- PCR after 14 days since the beginning of the disease. of the randomization
Measured: DAY 14
Tolerance
Évaluate the tolerance of the study product (Nano-S1) versus placebo on the occurrence of adverse events
Measured: DAY 14, DAY 30
Systemic passage
- 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.
Measured: DAY 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start1 Jan 2021
- Primary completion1 Jan 2022
- Study completion20 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Administration of Military Health, Tunisia
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822180
- Sponsor's protocol ID
- COVID NANO S1
- Acronym
- COVNANOS1
- Status last verified
- Jan 2022
- First submitted
- 19 Apr 2023
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Nano-S1 in Adult Patients Infected With SARS-Cov-2: "COVID Nano-S1
- ClinicalTrials.gov ID
- NCT05822180
- Acronym / sponsor ID
- COVNANOS1 / COVID NANO S1
- Conditions
- COVID-19 Pneumonia
- Keywords
- ARGENT COLLOIDAL
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- General Administration of Military Health, TunisiaResearch network
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 20 Feb 2022 (actual)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A bras actif | Experimental | Drug: 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 | Placebo comparator | Drug: 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (1 listed)
- Non observance.Non-compliant patient With drawal of Consent. Patient who refuses blood samples.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NANOS1 , argent colloïdal ,orally, during 5 day | Drug | A bras actif, B bras controle |
Primary outcome
Clinical evolution
Time frame: 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)
5 secondary outcomes
Disappearance of clinical signs
Time frame: 3 days
Viral load Ct value
Time frame: admission ,DAY6, DAY14
Negativation of the RT- PCR
Time frame: DAY 14
Tolerance
Time frame: DAY 14, DAY 30
Systemic passage
Time frame: DAY 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NANOS1 , argent colloïdal , in people with COVID-19 Pneumonia, run by General Administration of Military Health, Tunisia at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical evolution (time frame: 14DAY). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2023.