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Colloidal Silver, Treatment of COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04978025
Recruitment Status : Recruiting
First Posted : July 27, 2021
Last Update Posted : July 27, 2021
Sponsor:
Information provided by (Responsible Party):
Riadh Boukef, Hôpital Universitaire Sahloul

Tracking Information
First Submitted Date  ICMJE November 5, 2020
First Posted Date  ICMJE July 27, 2021
Last Update Posted Date July 27, 2021
Actual Study Start Date  ICMJE November 1, 2020
Estimated Primary Completion Date November 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2021)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2021)
  • Adverse events [ Time Frame: ON 1 month ]
    adverse events throughout the study period
  • the duration of hospitalization [ Time Frame: ON 11 days ]
    number of days of hospitalization
  • the duration of the different respiratory assistance modes [ Time Frame: ON 11 days ]
    the duration of the different respiratory assistance modes
  • all-cause mortality [ Time Frame: ON 1 month ]
    the cause and the date of Death
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Colloidal Silver, Treatment of COVID-19
Official Title  ICMJE The Value of Colloidal Silver in the Treatment of COVID-19
Brief 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 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE SARS (Severe Acute Respiratory Syndrome)
Intervention  ICMJE
  • Drug: Colloidal Silver

    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 Name: Experimental
  • 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.
Study Arms  ICMJE
  • Experimental: Silver Group
    • 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.
    Intervention: Drug: Colloidal Silver
  • 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.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 26, 2021)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2021
Estimated Primary Completion Date November 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Boukef Riadh, professor 00 216 98 676 745 riadboukef@gmail.com
Listed Location Countries  ICMJE Tunisia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04978025
Other Study ID Numbers  ICMJE colloidal silver and COVID-19
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Riadh Boukef, Hôpital Universitaire Sahloul
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Hôpital Universitaire Sahloul
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Boukef Riadh, professor HU Sahloul
PRS Account Hôpital Universitaire Sahloul
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP