SARS (Severe Acute Respiratory Syndrome)NCT04978025
Colloidal Silver, Treatment of COVID-19
A study testing Colloidal Silver in people with SARS (Severe Acute Respiratory Syndrome), run by Hôpital Universitaire Sahloul at 1 site in Tunisia.
Trial summary
Noble metals such as gold and silver have been appreciated for millennia not only for their beauty but also for their ability to fight diseases. Silver nanoparticles (AgNPs) have been employed as chemical drugs thanks to their unique physiochemical and chemical properties as well as biological features, such as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS (Severe Acute Respiratory Syndrome)
- What is being tested?
- Colloidal Silver
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Nov 2020to 1 Nov 2021
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion of any patient, over the age of 18, consulting the Sahloul emergencies, Sousse for symptoms of COVID -19 dating less than 10 days and having a positive COVID-19 on the PCR test and typical scanner.
Who cannot join
- Any pregnant or breastfeeding woman
- patient with an expectation of survival of less than 24 hours
- Dyspnea leading to heart failure
- Hepatic insufficiency
- Chronic respiratory failure
- Renal failure, clearance <20ml • min-1 • 1.73 • m-²
Trial locations and contacts
1 site in 1 country.
Tunisia1 site, 1 recruiting
- Recruiting
HU Sahloul, sousse, Tunisia
Sousse, Itinéraire Ceinture Cité Sahloul, 4054
boukef riadh, professor, 73 369 411, riadboukef@gmail.com
About this study
Official title: The Value of Colloidal Silver in the Treatment of COVID-19
Noble metals such as gold and silver have been appreciated for millennia not only for their beauty but also for their ability to fight diseases.
Silver nanoparticles (AgNPs) have been employed as chemical drugs thanks to their unique physiochemical and chemical properties as well as biological features, such as anti-inflammatory, anti-angiogenesis, antiplatelet, antifungal, anti-cancer and antibacterial activities I
Read the detailed description
Noble metals such as gold and silver have been appreciated for millennia not only for their beauty but also for their ability to fight diseases.
Silver nanoparticles (AgNPs) have been employed as chemical drugs thanks to their unique physiochemical and chemical properties as well as biological features, such as anti-inflammatory, anti-angiogenesis, antiplatelet, antifungal, anti-cancer and antibacterial activities Infectious diseases account for more than 20% of global mortality and viruses are responsible for about one-third of these deaths. Highly infectious viral diseases such as severe acute respiratory (SARS), Middle East respiratory syndrome (MERS) and coronavirus disease (COVID-19) are emerging more frequently and their worldwide spread poses a serious threat to human health and the global economy.
The current COVID-19 pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) .
- Conditions
- SARS (Severe Acute Respiratory Syndrome)
- Being tested
- Colloidal Silver, Placebo
- Keywords
- colloidal silver, treatment, COVID-19
- Medical subject headings
- Severe Acute Respiratory Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colloidal SilverDrug
Also called Experimental
Orally: colloidal silver 1 dose of 30ml, 3 times a day for 5 days (use a plastic measuring cup and not a measuring cup or a metal spoon)
and By inhalation: nebulization of 5ml of colloidal silver solution once, 3 times a day for 5 days.
PlaceboDrug
Orally: EPPI 1 dose of 30 ml, 3 times a day for 5 days By inhalation: nebulization of 5ml of EPPI solution once a day, 3 times a day for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Silver Group | Experimental | * Orally: the colloidal agent 1 dose of 30ml, 3 times a day for 5 days (use a plastic measuring cup and not a measuring cup or a metal spoon)
* By inhalation: nebulization of 5ml of colloidal silver solution once, 3 times a day for 5 days. Receives: Drug: Colloidal Silver |
| Placebo Group | Placebo comparator | * Orally: EPPI 1 dose of 30 ml, 3 times a day for 5 days
* By inhalation: nebulization of 5ml of EPPI solution once a day, 3 times a day for 5 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chage of clinical status
the distribution of clinical status assessed on the 7-point ordinal scale on day 10 of the study
Measured: 10 DAYS
Secondary outcomes (4)
Adverse events
adverse events throughout the study period
Measured: ON 1 month
the duration of hospitalization
number of days of hospitalization
Measured: ON 11 days
the duration of the different respiratory assistance modes
the duration of the different respiratory assistance modes
Measured: ON 11 days
all-cause mortality
the cause and the date of Death
Measured: ON 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start1 Nov 2020
- Primary completion1 Nov 2021 (estimated)
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS (Severe Acute Respiratory Syndrome)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital Universitaire Sahloul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riadh Boukef, Hôpital Universitaire Sahloul
- Investigators
- Boukef Riadh, professor, Principal investigator, HU Sahloul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978025
- Sponsor's protocol ID
- colloidal silver and COVID-19
- Status last verified
- Jul 2021
- First submitted
- 5 Nov 2020
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Colloidal Silver in the Treatment of COVID-19
- ClinicalTrials.gov ID
- NCT04978025
- Acronym / sponsor ID
- colloidal silver and COVID-19
- Conditions
- SARS (Severe Acute Respiratory Syndrome)
- Keywords
- colloidal silver, treatment, COVID-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hôpital Universitaire SahloulUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 27 Jul 2021 (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.
Noble metals such as gold and silver have been appreciated for millennia not only for their beauty but also for their ability to fight diseases.
Silver nanoparticles (AgNPs) have been employed as chemical drugs thanks to their unique physiochemical and chemical properties as well as biological features, such as anti-inflammatory, anti-angiogenesis, antiplatelet, antifungal, anti-cancer and antibacterial activities I
Detailed description
Noble metals such as gold and silver have been appreciated for millennia not only for their beauty but also for their ability to fight diseases.
Silver nanoparticles (AgNPs) have been employed as chemical drugs thanks to their unique physiochemical and chemical properties as well as biological features, such as anti-inflammatory, anti-angiogenesis, antiplatelet, antifungal, anti-cancer and antibacterial activities Infectious diseases account for more than 20% of global mortality and viruses are responsible for about one-third of these deaths. Highly infectious viral diseases such as severe acute respiratory (SARS), Middle East respiratory syndrome (MERS) and coronavirus disease (COVID-19) are emerging more frequently and their worldwide spread poses a serious threat to human health and the global economy.
The current COVID-19 pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silver Group | Experimental | Drug: Colloidal Silver* Orally: the colloidal agent 1 dose of 30ml, 3 times a day for 5 days (use a plastic measuring cup and not a measuring cup or a metal spoon) * By inhalation: nebulization of 5ml of colloidal silver solution once, 3 times a day for 5 days. |
| Placebo Group | Placebo comparator | Drug: Placebo* Orally: EPPI 1 dose of 30 ml, 3 times a day for 5 days * By inhalation: nebulization of 5ml of EPPI solution once a day, 3 times a day for 5 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion of any patient, over the age of 18, consulting the Sahloul emergencies, Sousse for symptoms of COVID -19 dating less than 10 days and having a positive COVID-19 on the PCR test and typical scanner.
Key exclusion criteria (6 listed)
- Any pregnant or breastfeeding woman
- patient with an expectation of survival of less than 24 hours
- Dyspnea leading to heart failure
- Hepatic insufficiency
- Chronic respiratory failure
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 |
|---|---|---|
| Colloidal SilverAlso: ExperimentalOrally: colloidal silver 1 dose of 30ml, 3 times a day for 5 days (use a plastic measuring cup and not a measuring cup or a metal spoon) and By inhalation: nebulization of 5ml of colloidal silver solution once, 3 times a day for 5 days. | Drug | Silver Group |
| PlaceboOrally: EPPI 1 dose of 30 ml, 3 times a day for 5 days By inhalation: nebulization of 5ml of EPPI solution once a day, 3 times a day for 5 days. | Drug | Placebo Group |
Primary outcome
Chage of clinical status
Time frame: 10 DAYS
the distribution of clinical status assessed on the 7-point ordinal scale on day 10 of the study
4 secondary outcomes
Adverse events
Time frame: ON 1 month
the duration of hospitalization
Time frame: ON 11 days
the duration of the different respiratory assistance modes
Time frame: ON 11 days
all-cause mortality
Time frame: ON 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- 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.
Boukef Riadh, professor principal investigator
HU Sahloul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colloidal Silver in people with SARS (Severe Acute Respiratory Syndrome), run by Hôpital Universitaire Sahloul 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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 27 Jul 2021. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Boukef Riadh, professor (00 216 98 676 745, riadboukef@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chage of clinical status (time frame: 10 DAYS). 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 27 Jul 2021.