COVID-19Phase 2/3NCT04333628
Chloroquine for Mild Symptomatic and Asymptomatic COVID-19
A Phase 2/3 study testing chloroquine in people with COVID-19, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- chloroquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jun 2020to 1 Sep 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18
- A person diagnosed with COVID-19 in the past 48 hours
- Asymptomatic
Who cannot join
- chronic lung disease with chronic hypoxia
- Sleep apnea requiring BIPAP / continuous positive airway pressure
- Retinal disease
- Porphyria
- Myastenia gravis
- immunodeficiency disorders
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chloroquine for Mild Symptomatic and Asymptomatic COVID-19 in A Two Staged, Multicenter, Open Label and Randomized Trial
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- chloroquine, standard care
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chloroquineDrug
oral treatment of chloroquine
standard careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| low dose chloroquine | Experimental | oral chloroquine 125mg daily for 7 days (or until the condition worsens, whichever comes first) Receives: Drug: chloroquine |
| Regular dose chloroquine | Experimental | oral chloroquine 500 mg twice daily for 7 days (or until the condition worsens, whichever comes first) Receives: Drug: chloroquine |
| Standard of care | Other | The treatment is mostly supportive in character and is given, based on patient's clinical state. Antibiotics do not help patients fight novel coronavirus. Receives: Other: standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in virus duration (viral shedding)
change in the extent and duration of virus shedding.
Measured: 23 days
change in the number of patients going from asymptomatic to moderately disease
change in the number of patients going from asymptomatic to moderately disease
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start1 Jun 2020
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Why it stopped: Teminated due to changes in treatment guidelines .
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will compare three groups of treatment, identical of their size (by randomization table) group 1- 125mgx1 / d low dose chloroquine group for 7 days (or until the condition worsens, whichever comes first) group 2- Regular dose chloroquine dose at 500mgx2 / d for 7 days (or until the condition worsens, whichever comes first) 3. Standard treatment group. We will monitor patients' clinical status and periodic PCR (Polymerase Chain Reaction) results from nasal and pharyngeal surfaces.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Collaborators
- T MAY BIOPHARMA LTD.
- Responsible party
- Sponsor
- Investigators
- Lee Goldstein, MD, Principal investigator, HaEmek Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04333628
- Sponsor's protocol ID
- EMC 0045-20
- Status last verified
- Oct 2020
- First submitted
- 1 Apr 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chloroquine for Mild Symptomatic and Asymptomatic COVID-19 in A Two Staged, Multicenter, Open Label and Randomized Trial
- ClinicalTrials.gov ID
- NCT04333628
- Acronym / sponsor ID
- EMC 0045-20
- Conditions
- COVID-19
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Teminated due to changes in treatment guidelines .
- Enrolment
- 5 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Collaborators
- T MAY BIOPHARMA LTD.
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 3 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study will compare three groups of treatment, identical of their size (by randomization table) group 1- 125mgx1 / d low dose chloroquine group for 7 days (or until the condition worsens, whichever comes first) group 2- Regular dose chloroquine dose at 500mgx2 / d for 7 days (or until the condition worsens, whichever comes first) 3. Standard treatment group. We will monitor patients' clinical status and periodic PCR (Polymerase Chain Reaction) results from nasal and pharyngeal surfaces.
| Arm | Type | Receives |
|---|---|---|
| low dose chloroquine | Experimental | Drug: chloroquineoral chloroquine 125mg daily for 7 days (or until the condition worsens, whichever comes first) |
| Regular dose chloroquine | Experimental | Drug: chloroquineoral chloroquine 500 mg twice daily for 7 days (or until the condition worsens, whichever comes first) |
| Standard of care | Other | Other: standard careThe treatment is mostly supportive in character and is given, based on patient's clinical state. Antibiotics do not help patients fight novel coronavirus. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age over 18
- A person diagnosed with COVID-19 in the past 48 hours
- Asymptomatic
Key exclusion criteria (14 listed)
- chronic lung disease with chronic hypoxia
- Sleep apnea requiring BIPAP / continuous positive airway pressure
- Retinal disease
- Porphyria
- Myastenia gravis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chloroquineoral treatment of chloroquine | Drug | Regular dose chloroquine, low dose chloroquine |
| standard careCurrently, 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. | Other | Standard of care |
Primary outcome
change in virus duration (viral shedding)
Time frame: 23 days
change in the extent and duration of virus shedding.
change in the number of patients going from asymptomatic to moderately disease
Time frame: 1 month
change in the number of patients going from asymptomatic to moderately disease
Results and safety
The study was stopped early (reason given: Teminated due to changes in treatment guidelines .). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee Goldstein, MD principal investigator
HaEmek Medical Center, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing chloroquine in people with COVID-19, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Teminated due to changes in treatment guidelines .). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in virus duration (viral shedding) (time frame: 23 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.