Official Title
Chloroquine for Mild Symptomatic and Asymptomatic COVID-19 in A Two Staged, Multicenter, Open Label and Randomized Trial
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.

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, Investigator's 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, Investigator's 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.

Terminated
COVID-19

Drug: chloroquine

oral treatment of chloroquine

Other: standard care

Currently, there is no specific treatment for novel coronavirus. The treatment is mostly supportive in character and is given, based on patient's clinical state. Antibiotics do not help patients fight novel coronavirus.

Eligibility Criteria

Inclusion Criteria:

- Age over 18

- A person diagnosed with COVID-19 in the past 48 hours

- Asymptomatic

Exclusion Criteria:

- chronic lung disease with chronic hypoxia

- Sleep apnea requiring BIPAP / continuous positive airway pressure

- Retinal disease

- Porphyria

- Myastenia gravis

- immunodeficiency disorders

- Hearing Disorders

- Scheduled for general anesthesia

- treatment with antibiotics or antiretroviral for any reason

- Pulse <50

- Known Ventricular arrhythmias

- Heart Failure: Systolic or Diastolic

- kown QT prolongation

- Taking medicines that increase the risk of QT prolongation in combination with
CHLOROQUINE.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Israel
Locations

Haemek Medical Center
Afula, Israel

Lee Goldstein, MD, Principal Investigator
HaEmek Medical Center, Israel

T MAY BIOPHARMA LTD.
NCT Number
MeSH Terms
COVID-19
Chloroquine