Colloidal Silver, Treatment of COVID-19

July 26, 2021 updated by: Riadh Boukef, Hôpital Universitaire Sahloul

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

Recruiting

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

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Itinéraire Ceinture Cité Sahloul
      • Sousse, Itinéraire Ceinture Cité Sahloul, Tunisia, 4054
        • Recruiting
        • HU Sahloul, sousse, Tunisia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: 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.

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:
  • Experimental
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.
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Boukef Riadh, professor, HU Sahloul

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Anticipated)

November 1, 2021

Study Completion (Anticipated)

November 1, 2021

Study Registration Dates

First Submitted

November 5, 2020

First Submitted That Met QC Criteria

July 26, 2021

First Posted (Actual)

July 27, 2021

Study Record Updates

Last Update Posted (Actual)

July 27, 2021

Last Update Submitted That Met QC Criteria

July 26, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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