Chloroquine for Mild Symptomatic and Asymptomatic COVID-19

NCT04333628 | Terminated Phase 2 DMC

• 1 other identifier: EMC 0045-20
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• change in virus duration (viral shedding)

  change in the extent and duration of virus shedding.

  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

  1 month

Study Arms (3)

low dose chloroquine

EXPERIMENTAL

oral chloroquine 125mg daily for 7 days (or until the condition worsens, whichever comes first)

Drug: chloroquine

Regular dose chloroquine

EXPERIMENTAL

oral chloroquine 500 mg twice daily for 7 days (or until the condition worsens, whichever comes first)

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.

Other: standard care

Interventions

chloroquine DRUG

oral treatment of chloroquine

Regular dose chloroquine; low dose chloroquine

standard care OTHER

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.

Standard of care

Eligibility Criteria

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

You may qualify if:

• Age over 18
• A person diagnosed with COVID-19 in the past 48 hours
• Asymptomatic

You may not qualify if:

• 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.

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead
• T MAY BIOPHARMA LTD.: collaborator

Study Sites (1)

Haemek Medical Center

Afula, Israel

Location

MeSH Terms

Conditions

COVID-19

Interventions

Chloroquine; Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Lee Goldstein, MD

  HaEmek Medical Center, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 3, 2020
• Study Start: June 1, 2020
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)