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Colloidal Silver, Treatment of COVID-19

Primary Purpose

SARS (Severe Acute Respiratory Syndrome)

Status
Unknown status
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
Colloidal Silver
Placebo
Sponsored by
Hôpital Universitaire Sahloul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SARS (Severe Acute Respiratory Syndrome) focused on measuring colloidal silver, treatment, COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • HU Sahloul, sousse, TunisiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Silver Group

Placebo Group

Arm Description

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: 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.

Outcomes

Primary Outcome Measures

Chage of clinical status
the distribution of clinical status assessed on the 7-point ordinal scale on day 10 of the study

Secondary Outcome Measures

Adverse events
adverse events throughout the study period
the duration of hospitalization
number of days of hospitalization
the duration of the different respiratory assistance modes
the duration of the different respiratory assistance modes
all-cause mortality
the cause and the date of Death

Full Information

First Posted
November 5, 2020
Last Updated
July 26, 2021
Sponsor
Hôpital Universitaire Sahloul
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1. Study Identification

Unique Protocol Identification Number
NCT04978025
Brief Title
Colloidal Silver, Treatment of COVID-19
Official Title
The Value of Colloidal Silver in the Treatment of COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
November 1, 2021 (Anticipated)
Study Completion Date
November 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hôpital Universitaire Sahloul

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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) .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS (Severe Acute Respiratory Syndrome)
Keywords
colloidal silver, treatment, COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Silver Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Colloidal Silver
Other Intervention Name(s)
Experimental
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Chage of clinical status
Description
the distribution of clinical status assessed on the 7-point ordinal scale on day 10 of the study
Time Frame
10 DAYS
Secondary Outcome Measure Information:
Title
Adverse events
Description
adverse events throughout the study period
Time Frame
ON 1 month
Title
the duration of hospitalization
Description
number of days of hospitalization
Time Frame
ON 11 days
Title
the duration of the different respiratory assistance modes
Description
the duration of the different respiratory assistance modes
Time Frame
ON 11 days
Title
all-cause mortality
Description
the cause and the date of Death
Time Frame
ON 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Boukef Riadh, professor
Phone
00 216 98 676 745
Email
riadboukef@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boukef Riadh, professor
Organizational Affiliation
HU Sahloul
Official's Role
Principal Investigator
Facility Information:
Facility Name
HU Sahloul, sousse, Tunisia
City
Sousse
State/Province
Itinéraire Ceinture Cité Sahloul
ZIP/Postal Code
4054
Country
Tunisia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
boukef riadh, professor
Phone
73 369 411
Email
riadboukef@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Colloidal Silver, Treatment of COVID-19

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