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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04978025
Other study ID # colloidal silver and COVID-19
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2020
Est. completion date November 1, 2021

Study information

Verified date July 2021
Source Hôpital Universitaire Sahloul
Contact Boukef Riadh, professor
Phone 00 216 98 676 745
Email riadboukef@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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) .


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date November 1, 2021
Est. primary completion date November 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • SARS (Severe Acute Respiratory Syndrome)
  • Severe Acute Respiratory Syndrome

Intervention

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.
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.

Locations

Country Name City State
Tunisia HU Sahloul, sousse, Tunisia Sousse Itinéraire Ceinture Cité Sahloul

Sponsors (1)

Lead Sponsor Collaborator
Hôpital Universitaire Sahloul

Country where clinical trial is conducted

Tunisia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Adverse events adverse events throughout the study period ON 1 month
Secondary the duration of hospitalization number of days of hospitalization ON 11 days
Secondary the duration of the different respiratory assistance modes the duration of the different respiratory assistance modes ON 11 days
Secondary all-cause mortality the cause and the date of Death ON 1 month
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