- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04978025
Colloidal Silver, Treatment of COVID-19
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Boukef Riadh, professor
- Phone Number: 00 216 98 676 745
- Email: riadboukef@gmail.com
Study Locations
-
-
Itinéraire Ceinture Cité Sahloul
-
Sousse, Itinéraire Ceinture Cité Sahloul, Tunisia, 4054
- Recruiting
- HU Sahloul, sousse, Tunisia
-
Contact:
- boukef riadh, professor
- Phone Number: 73 369 411
- Email: riadboukef@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Silver Group
|
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.
Other Names:
|
|
Placebo Comparator: Placebo Group
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
10 DAYS
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adverse events
Time Frame: ON 1 month
|
adverse events throughout the study period
|
ON 1 month
|
|
the duration of hospitalization
Time Frame: ON 11 days
|
number of days of hospitalization
|
ON 11 days
|
|
the duration of the different respiratory assistance modes
Time Frame: ON 11 days
|
the duration of the different respiratory assistance modes
|
ON 11 days
|
|
all-cause mortality
Time Frame: ON 1 month
|
the cause and the date of Death
|
ON 1 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Boukef Riadh, professor, HU Sahloul
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- colloidal silver and COVID-19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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