Colloidal Silver, Treatment of COVID-19

NCT04978025 | Unknown

• 1 other identifier: colloidal silver and COVID-19
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

SARS (Severe Acute Respiratory Syndrome)

Keywords

colloidal silver; treatment; COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 (4)

• Adverse events

  ON 1 month

• the duration of hospitalization

  ON 11 days

• the duration of the different respiratory assistance modes

  ON 11 days

• all-cause mortality

  ON 1 month

Study Arms (2)

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

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.

Also known as: Experimental

Silver Group

Placebo DRUG

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.

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hôpital Universitaire Sahloul: lead

Study Sites (1)

HU Sahloul, sousse, Tunisia

Sousse, Itinéraire Ceinture Cité Sahloul, 4054, Tunisia

RECRUITING

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; COVID-19

Interventions

colloidal silver

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases

Study Officials

• Boukef Riadh, professor

  HU Sahloul

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Boukef Riadh, professor

CONTACT

00 216 98 676 745; riadboukef@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: July 27, 2021
• Study Start: November 1, 2020
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: July 27, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)