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Colloidal Silver, Treatment of COVID-19

Sponsor
Hôpital Universitaire Sahloul (Other)
Overall Status
Recruiting
CT.gov ID
NCT04978025
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
4.2
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Colloidal Silver
  • Drug: Placebo
 N/A

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 Design

Study Type:
Interventional
Anticipated 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 :
Nov 1, 2020
Anticipated Primary Completion Date :
Nov 1, 2021
Anticipated Study Completion Date :
Nov 1, 2021

Arms and Interventions

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 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.

    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.

    Outcome Measures

    Primary Outcome Measures

    1. Chage of clinical status [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 [ON 1 month]

      adverse events throughout the study period

    2. the duration of hospitalization [ON 11 days]

      number of days of hospitalization

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

      the duration of the different respiratory assistance modes

    4. all-cause mortality [ON 1 month]

      the cause and the date of Death

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 HU Sahloul, sousse, Tunisia Sousse Itinéraire Ceinture Cité Sahloul Tunisia 4054

    Sponsors and Collaborators

    • Hôpital Universitaire Sahloul

    Investigators

    • Principal Investigator: Boukef Riadh, professor, HU Sahloul

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Riadh Boukef, PROFESSOR, Hôpital Universitaire Sahloul
    ClinicalTrials.gov Identifier:
    NCT04978025
    Other Study ID Numbers:
    • colloidal silver and COVID-19
    First Posted:
    Jul 27, 2021
    Last Update Posted:
    Jul 27, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Riadh Boukef, PROFESSOR, Hôpital Universitaire Sahloul
    colloidal silver
    treatment
    COVID-19
    Additional relevant MeSH terms:
    COVID-19
    Severe Acute Respiratory Syndrome

    Study Results

    No Results Posted as of Jul 27, 2021