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The Vietnam Chloroquine Treatment on COVID-19 (VICO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04328493
Recruitment Status : Recruiting
First Posted : March 31, 2020
Last Update Posted : May 29, 2020
Sponsor:
Collaborators:
Ministry of Health, Vietnam
Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
Cu Chi COVID Hospital, Vietnam
Can Gio COVID Hospital, Vietnam
Cho Ray Hospital, Vietnam
National Hospital for Tropical Diseases, Hanoi, Vietnam
Department of Health, Ho Chi Minh city
Information provided by (Responsible Party):
Oxford University Clinical Research Unit, Vietnam

Brief Summary:

COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. There is currently no vaccine to prevent COVID-19 or therapeutic agent to treat COVID-19. This clinical trial is designed to evaluate potential therapeutics for the treatment of hospitalized COVID-19.

We hypothesis that chloroquine slows viral replication in patients with COVID-19, attenuating the infection, and resulting in more rapid declines in viral load in throat swabs. This viral attenuation should be associated with improved patient outcomes. Given the enormous experience of its use in malaria chemoprophylaxis, excellent safety and tolerability profile, and its very low cost, if proved effective then chloroquine would be a readily deployable and affordable treatment for patients with COVID-19.

The study is funded and leaded by The Ministry of Health, Vietnam.


Condition or disease Intervention/treatment Phase
SARS-CoV-2 Infection COVID-19 Drug: Chloroquine phosphate Phase 2

Detailed Description:

The study will start with a 10-patient prospective observational pilot study. All these patients will be subject to the same entry and exclusion criteria for the randomized trial, and undergo the same procedures. They will all receive chloroquine at the doses used in the trial (see sections below); they will not be randomized. The purpose of the pilot is to develop the study procedures for the randomized controlled trial, including the safe monitoring of patients, to refine the CRF, and to acquire some preliminary data on the safety of chloroquine in those with COVID-19.

Once the pilot study has been completed, and the data reviewed by the TSC and DMC, and the MOH ethics committee, we will then proceed to the trial. We will aim for minimum delay between completing the pilot study and starting the randomized trial.

The main study is an open label, randomised, controlled trial that will be conducted in 240 in-patients in Ho Chi Minh City. Viet Nam.

Patients will have daily assessment as per standard of care while in-patients by the hospital staff. While in-patients the study will collect the following data: peripheral oxygen saturation (pulse oximeter), respiratory rate, and FiO2. These will be recorded between 2 and 4 times per day depending on the practice of the treating site. Where recording is twice daily, one record will be made from the time period of 00:00 until 12:00, and the second recording between 12:01 and 23:59. Where the parameters are recorded four times/day they will be recorded in each of the time periods 00:00 - 06:00, 06:01 - 12:00, 12:01 - 18:00 and 18:01 - 23:59. Vitals recorded will include: FiO2, SpO2, Temp, RR HR BP. The use of ventilator or other assisted breathing device will be recorded each day.

Patients will have clinical assessment recorded as per the study schedule.

The decision to discharge patients will be at the discretion of the attending physician and depend upon the clinical status of the patient. According to current standard of care recovery and hospital discharge is dependent upon the patient having had 2 daily consecutive negative PCR throat/nose swabs. Following discharge patients will be seen on days 14, 28, 42 and 56 post-randomization.

In a subset of patients admitted to HTD we will look for ECG changes, using real-time monitoring.

Patients will have up to 1 hour ECG continuous recordings daily. The ECG recording will be downloaded from standard monitor (GE Careview) and stored electronically. ECG changes (including QT interval) will then be analyzed by machine learning.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The main trial is an open label, randomised, controlled trial that will be conducted in in-patients in Ho Chi Minh City. Viet Nam. Randomization will be 1:1, stratified by study site and severity of illness, to either with or without chloroquine for 10 days. All patients will also receive a supportive care/treatment according to VN MoH's guidline for COVID-19
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi Center Randomized Open Label Trial on the Safety and Efficacy of Chloroquine for the Treatment of Hospitalized Adults With Laboratory Confirmed SARS-CoV-2 Infection in Vietnam
Actual Study Start Date : April 7, 2020
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 1, 2022


Arm Intervention/treatment
No Intervention: Control arm
Patients randomized to the control arm will receive a standard of care therapy (a supportive care/treatment according to VN MoH's guideline).
Experimental: Intervention arm

In addition to standard of care therapy, patients randomized to the intervention arm receive chloroquine phosphate as below.

For adult ≥ 53kg: 1000mg (4 tablets) at initial dose (T=0), followed by 500mg (2 tablets) at 6 hours later (T=6), and 500mg (2 tablets) once daily for 9 days.

For adult from 45 - 52kg: 875mg (3.5 tablets) at T=0, followed by 500mg (2 tablets) at T=6 and 500mg (2 tablets) once daily thereafter.

For adult weighted 38 -<45 kg: 750mg (3 tablets) at T=0, followed by 375mg (1.5 tablets) at T = 6 and 375mg (1.5 tablets) once daily thereafter.

For adult weighted <38 kg: 625mg (2.5 tablets) at T=0, followed by 375mg (1.5 tablets) at T=6 and 375mg (1.5 tablets) once daily thereafter.

The total duration of treatment with chloroquine will be 10 days.

Drug: Chloroquine phosphate

Each chloroquine tablet contains 250mg chloroquine phosphate (or 150mg chloroquine base). Chloroquine treatment for patient is weight-based dosing.

Chloroquine will be administered orally, as tablets. For unconscious patients chloroquine can be crushed and administered as a suspension via a nasogastric tube.

The total duration of treatment with Chloroquine will be 10 days

Other Name: Chloroquine




Primary Outcome Measures :
  1. Viral clearance time [ Time Frame: Up to 56 days post randomization ]
    Viral presence will be determined using RT-PCR to detect SARS-CoV-19 RNA. Throat/nose swabs for viral RNA will be taken daily while in hospital until there have at least 2 consecutive negative results . Virus will be defined as cleared when the patient has had ≥2 consecutive negative PCR tests. The time to viral clearance will be defined as the time following randomization to the first of the negative throat/nose swabs.


Secondary Outcome Measures :
  1. Lengh of hospital stay [ Time Frame: Up to 56 days post randomization ]
    The time since randomization to discharge between study groups

  2. Ventilator free days [ Time Frame: first 28 days ]
    The number of ventilator free days over the first 28 days of treatment

  3. Oxygene free days [ Time Frame: first 28 days ]
    The number of oxygene free days over the first 28 days of treatment

  4. Time to death [ Time Frame: first 7, 10, 14, 28 and 56 days since randomization ]
    The time to (all-cause) death following over the first 7, 10, 14, 28 and 56 days since randomization

  5. Adverse events [ Time Frame: Over the first 28 days (due to the prolonged half-life of Chloroquine) ]
    The rates of serious adverse events, rates of grade 3 or 4 adverse events

  6. fever clearance time [ Time Frame: Up to 56 days post randomization ]
    Time since randomization to the first defervescence day

  7. Ordinal outcome scale [ Time Frame: Up to 56 days post randomization ]
    WHO Ordinal outcome scale for COVID-19

  8. Development of ARDS [ Time Frame: Up to 56 days post randomization ]
    Development of ARDS defined by the Kigali criteria



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  1. Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen < 48 hours prior to randomization, and requiring hospital admission in the opinion of the attending physician.
  2. Provides written informed consent prior to initiation of any study procedures (or legally authorized representative).
  3. Understands and agrees to comply with planned study procedures.
  4. Agrees to the collection of OP swabs and venous blood per protocol.
  5. Male or female adult ≥18 years of age at time of enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04328493


Contacts
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Contact: Jeremy Day, PhD. MD +84 8 39237954 jday@oucru.org
Contact: Dung Nguyen, PhD. MD +84 28 3924 1983 CTU-Admin@oucru.org

Locations
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Vietnam
National Hospital for Tropical Diseases Not yet recruiting
Hanoi, Vietnam
Contact: Thach N Pham, PhD. MD         
Principal Investigator: Thach N Pham, PhD.MD         
Can Gio COVID Hospital Recruiting
Ho Chi Minh City, Vietnam
Contact: Manh Hung Le         
Principal Investigator: Manh Hung Le         
Cho Ray Hospital Not yet recruiting
Ho Chi Minh City, Vietnam
Principal Investigator: Hung Le Quoc, MD         
Cu Chi COVID Hospital Recruiting
Ho Chi Minh City, Vietnam
Contact: Thanh Dung Nguyen         
Principal Investigator: Thanh Dung Nguyen         
Hospital for Tropical Diseases Recruiting
Ho Chi Minh City, Vietnam
Contact: Van Vinh Chau Nguyen, PhD, MD       nguyenvanvinhchau@gmail.com   
Sub-Investigator: Thanh Dung Nguyen, Dr         
Sub-Investigator: Thanh Phong Nguyen, Dr         
Sub-Investigator: Thanh Truong Nguyen, Dr         
Sub-Investigator: Nguyen Huy Man Dinh, Dr         
Sub-Investigator: Phuong Thao Huynh, Phar         
Principal Investigator: Van Vinh Chau Nguyen, Dr         
Sponsors and Collaborators
Oxford University Clinical Research Unit, Vietnam
Ministry of Health, Vietnam
Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
Cu Chi COVID Hospital, Vietnam
Can Gio COVID Hospital, Vietnam
Cho Ray Hospital, Vietnam
National Hospital for Tropical Diseases, Hanoi, Vietnam
Department of Health, Ho Chi Minh city
Investigators
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Principal Investigator: Guy Thwaites, PhD. MD University of Oxford, UK
Additional Information:
Publications:

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Responsible Party: Oxford University Clinical Research Unit, Vietnam
ClinicalTrials.gov Identifier: NCT04328493    
Other Study ID Numbers: COVID
First Posted: March 31, 2020    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Oxford University Clinical Research Unit, Vietnam:
SARS-CoV-2
COVID-19
chloroquine
Additional relevant MeSH terms:
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Infection
Chloroquine
Chloroquine diphosphate
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Filaricides
Antinematodal Agents
Anthelmintics