Ignite Creation Date:
2024-05-06 @ 2:29 PM
Last Modification Date:
2024-10-26 @ 1:32 PM
Study NCT ID:
NCT04333628
Status:
TERMINATED
Last Update Posted:
2020-10-14
First Post:
2020-04-01
Brief Title:
Chloroquine for Mild Symptomatic and Asymptomatic COVID-19
Sponsor:
HaEmek Medical Center Israel
Organization:
HaEmek Medical Center Israel
Study Overview
Official Title:
Chloroquine for Mild Symptomatic and Asymptomatic COVID-19 in A Two Staged Multicenter Open Label and Randomized Trial
Status:
TERMINATED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Teminated due to changes in treatment guidelines
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
19 COVID Coronavirus disease 2019 is a deadly viral disease that has been spreading around the world for several months and is caused by a CORONA family virus COVID-19 Following IN-VITRO evidence of the antiviral effect of CHLOROQUINE in CORONA viruses this drug has been used empirically for COVID-19 patients and is currently recommended in Israel for the treatment of intermediate and severity disease
The mechanism of action of chloroquine is in part by inhibiting the virus distribution and changing the intracellular acidity the virus distribution site The intracellular chloroquine concentration is determined by a pump called PGP permeability glycoprotein that removes the drug from the cell and is activated by the drug In the treatment of malaria the benefit of low dosage of the drug has been shown to be effective due to the fact that the intracellular concentration of the drug is probably higher and therefore the logic to examine this issue in COVID-19 treatment
The purpose of this study is to test whether a low dose of Chloroquine will reduce the duration of the viral shedding and prevent the disease from worsening
The mechanism of action of chloroquine is in part by inhibiting the virus distribution and changing the intracellular acidity the virus distribution site The intracellular chloroquine concentration is determined by a pump called PGP permeability glycoprotein that removes the drug from the cell and is activated by the drug In the treatment of malaria the benefit of low dosage of the drug has been shown to be effective due to the fact that the intracellular concentration of the drug is probably higher and therefore the logic to examine this issue in COVID-19 treatment
The purpose of this study is to test whether a low dose of Chloroquine will reduce the duration of the viral shedding and prevent the disease from worsening
Detailed Description:
19 COVID is a deadly viral disease that has been spreading around the world for several months and is caused by a CORONA family virus COVID-19 This virus family causes upper respiratory tract disease and sometimes severe and fatal lung disease as in the past SARS-CoV severe acute respiratory syndrome and -MERS-CoV
Since the outbreak of the pandemic there has been a constant search for effective drug treatment for the disease Following IN-VITRO evidence of the antiviral effect of CHLOROQUINE in CORONA viruses this drug has been used empirically for COVID-19 patients and is currently recommended in Israel for the treatment of intermediate and severity disease
Currently it is not common to treat patients with mild illness or asymptomatic carriers In these situations isolation is recommended until upper respiratory tract surfaces no longer show the presence of the virus a period of approximately 20 days
The mechanism of action of chloroquine is in part by inhibiting the virus distribution and changing the intracellular acidity the virus distribution site The intracellular chloroquine concentration is determined by a pump called PGP that removes the drug from the cell and is activated by the drug In the treatment of malaria the benefit of low dosage of the drug has been shown to be effective due to the fact that the intracellular concentration of the drug is probably higher and therefore the logic to examine this issue in COVID-19 treatment
The purpose of this study is to test whether a low dose of Chloroquine will reduce the duration of the viral shedding and prevent the disease from worsening Reducing the duration of viral shedding shortens the time when there is a risk that the person will spread the disease and the time when the person is in isolation and cannot return to his normal life
The trial will be conducted in two stages first in patients with mild-grade symptomatology disease and then depending on the results of the first phase Investigators will consider chloroquine therapy in asymptomatic patients carriers only to reduce the duration of viral shedding and prevent the onset of symptomatic disease Chloroquine dosage at this stage will be determined by the results of the first stage In the first stage patients will be recruited at a slight level and will compare two doses of chloroquine low and normal with standard of care
In the second stage Investigators plan to examine asymptomatic carriers Progress between Phase 1 and Phase 2 of the experiment will be contingent upon receiving a renewed approval from the Helsinki Committee based on an interim report to be submitted
For the first study patients diagnosed with COVID-19 patients will be recruited in a mild condition with no background disease or drug therapy that endangers them with the side effects of chloroquine will monitor patients will be monitor for clinical status and periodic PCR polymerase chain reaction results from nasal and pharyngeal surfaces
Since the outbreak of the pandemic there has been a constant search for effective drug treatment for the disease Following IN-VITRO evidence of the antiviral effect of CHLOROQUINE in CORONA viruses this drug has been used empirically for COVID-19 patients and is currently recommended in Israel for the treatment of intermediate and severity disease
Currently it is not common to treat patients with mild illness or asymptomatic carriers In these situations isolation is recommended until upper respiratory tract surfaces no longer show the presence of the virus a period of approximately 20 days
The mechanism of action of chloroquine is in part by inhibiting the virus distribution and changing the intracellular acidity the virus distribution site The intracellular chloroquine concentration is determined by a pump called PGP that removes the drug from the cell and is activated by the drug In the treatment of malaria the benefit of low dosage of the drug has been shown to be effective due to the fact that the intracellular concentration of the drug is probably higher and therefore the logic to examine this issue in COVID-19 treatment
The purpose of this study is to test whether a low dose of Chloroquine will reduce the duration of the viral shedding and prevent the disease from worsening Reducing the duration of viral shedding shortens the time when there is a risk that the person will spread the disease and the time when the person is in isolation and cannot return to his normal life
The trial will be conducted in two stages first in patients with mild-grade symptomatology disease and then depending on the results of the first phase Investigators will consider chloroquine therapy in asymptomatic patients carriers only to reduce the duration of viral shedding and prevent the onset of symptomatic disease Chloroquine dosage at this stage will be determined by the results of the first stage In the first stage patients will be recruited at a slight level and will compare two doses of chloroquine low and normal with standard of care
In the second stage Investigators plan to examine asymptomatic carriers Progress between Phase 1 and Phase 2 of the experiment will be contingent upon receiving a renewed approval from the Helsinki Committee based on an interim report to be submitted
For the first study patients diagnosed with COVID-19 patients will be recruited in a mild condition with no background disease or drug therapy that endangers them with the side effects of chloroquine will monitor patients will be monitor for clinical status and periodic PCR polymerase chain reaction results from nasal and pharyngeal surfaces
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None