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Colloidal Silver, Treatment of COVID-19

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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

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


Condition or disease Intervention/treatment Phase
SARS (Severe Acute Respiratory Syndrome) Drug: Colloidal Silver Drug: Placebo Not Applicable

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) .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Value of Colloidal Silver in the Treatment of COVID-19
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : November 1, 2021

Resource links provided by the National Library of Medicine


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.
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

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.
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: ON 1 month ]
    adverse events throughout the study period

  2. the duration of hospitalization [ Time Frame: ON 11 days ]
    number of days of hospitalization

  3. the duration of the different respiratory assistance modes [ Time Frame: ON 11 days ]
    the duration of the different respiratory assistance modes

  4. all-cause mortality [ Time Frame: ON 1 month ]
    the cause and the date of Death



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04978025


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

Locations
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Tunisia
HU Sahloul, sousse, Tunisia Recruiting
Sousse, Itinéraire Ceinture Cité Sahloul, Tunisia, 4054
Contact: boukef riadh, professor    73 369 411    riadboukef@gmail.com   
Sponsors and Collaborators
Hôpital Universitaire Sahloul
Investigators
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Principal Investigator: Boukef Riadh, professor HU Sahloul
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Responsible Party: Riadh Boukef, PROFESSOR, Hôpital Universitaire Sahloul
ClinicalTrials.gov Identifier: NCT04978025    
Other Study ID Numbers: colloidal silver and COVID-19
First Posted: July 27, 2021    Key Record Dates
Last Update Posted: July 27, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Riadh Boukef, Hôpital Universitaire Sahloul:
colloidal silver
treatment
COVID-19
Additional relevant MeSH terms:
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Severe Acute Respiratory Syndrome
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases