Colloidal Silver, Treatment of COVID-19

• ClinicalTrials.gov Identifier: NCT04978025
• Recruitment Status: Recruiting
• First Posted: July 27, 2021
• Last Update Posted: July 27, 2021
• Sponsor: Hôpital Universitaire Sahloul
• Information provided by (Responsible Party): Riadh Boukef, Hôpital Universitaire Sahloul

Tracking Information

• First Submitted Date: November 5, 2020
• First Posted Date: July 27, 2021
• Last Update Posted Date: July 27, 2021
• Actual Study Start Date: November 1, 2020
• Estimated Primary Completion Date: November 1, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Colloidal Silver, Treatment of COVID-19
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: SARS (Severe Acute Respiratory Syndrome)

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 26, 2021): 50
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 1, 2021
• Estimated Primary Completion Date: November 1, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Boukef Riadh, professor; 00 216 98 676 745; riadboukef@gmail.com

• Listed Location Countries: Tunisia

Administrative Information

• NCT Number: NCT04978025
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Riadh Boukef, Hôpital Universitaire Sahloul
• Original Responsible Party: Same as current
• Current Study Sponsor: Hôpital Universitaire Sahloul
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Boukef Riadh, professor; HU Sahloul

• PRS Account: Hôpital Universitaire Sahloul
• Verification Date: July 2021