Colloidal Silver, Treatment of COVID-19 | NCT04978025

Studies
Colloidal Silver, Treatment of COVID-19

NCT04978025

Sponsor

Hôpital Universitaire Sahloul

Status

Unknown status

Last Update Posted

Jul 27, 2021Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

SARS (Severe Acute Respiratory Syndrome)

Interventions

Colloidal Silver
Placebo

Countries

Tunisia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2020Actual

Primary Completion Date

Nov 1, 2021Estimated

Completion Date

Nov 1, 2021Estimated

First Submitted Date

Nov 5, 2020

First Submission Date that Met QC Criteria

Jul 26, 2021

First Posted Date

Jul 27, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 26, 2021

Last Update Posted Date

Jul 27, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Riadh Boukef, PROFESSOR, Hôpital Universitaire SahloulPrincipal Investigator

Lead Sponsor

Hôpital Universitaire SahloulOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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) .

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Silver Group	Experimental	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.	Drug: Colloidal Silver
Placebo Group	Placebo Comparator	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.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Colloidal Silver	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Chage of clinical status	the distribution of clinical status assessed on the 7-point ordinal scale on day 10 of the study	10 DAYS

Secondary Outcomes

Measure	Description	Time Frame
Adverse events	adverse events throughout the study period	ON 1 month
the duration of hospitalization	number of days of hospitalization

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Boukef Riadh, professor	Contact	00 216 98 676 745		riadboukef@gmail.com

Overall Officials

Name	Affiliation	Role
Boukef Riadh, professor	HU Sahloul	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
HU Sahloul, sousse, Tunisia	Recruiting	Sousse	Itinéraire Ceinture Cité Sahloul	4054	Tunisia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D045169	Severe Acute Respiratory Syndrome
D000086382	COVID-19

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D018352	Coronavirus Infections
D003333	Coronaviridae Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C586932	colloidal silver

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided