The Vietnam Chloroquine Treatment on COVID-19 (VICO)

May 20, 2021 updated by: Oxford University Clinical Research Unit, Vietnam

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Hanoi, Vietnam
        • National Hospital for Tropical Diseases
      • Ho Chi Minh City, Vietnam
        • Hospital for Tropical Diseases
      • Ho Chi Minh City, Vietnam
        • Can Gio COVID Hospital
      • Ho Chi Minh City, Vietnam
        • Cho Ray Hospital
      • Ho Chi Minh City, Vietnam
        • Cu Chi COVID Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Chloroquine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 56 days post randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: Up to 56 days post randomization
The time since randomization to discharge between study groups
Up to 56 days post randomization
Ventilator free days
Time Frame: first 28 days
The number of ventilator free days over the first 28 days of treatment
first 28 days
Oxygen free days
Time Frame: first 28 days
The number of oxygen free days over the first 28 days of treatment
first 28 days
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
first 7, 10, 14, 28 and 56 days since randomization
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
Over the first 28 days (due to the prolonged half-life of Chloroquine)
fever clearance time
Time Frame: Up to 56 days post randomization
Time since randomization to the first defervescence day
Up to 56 days post randomization
Ordinal outcome scale
Time Frame: Up to 56 days post randomization
WHO Ordinal outcome scale for COVID-19
Up to 56 days post randomization
Development of ARDS
Time Frame: Up to 56 days post randomization
Development of ARDS defined by the Kigali criteria
Up to 56 days post randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oxford University Clinical Research Unit, Vietnam

Collaborators

National Hospital for Tropical Diseases, Hanoi, 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
Department of Health, Ho Chi Minh city

Investigators

  • Principal Investigator: Guy Thwaites, PhD. MD, University of Oxford, UK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2020

Primary Completion (Actual)

September 10, 2020

Study Completion (Actual)

September 10, 2020

Study Registration Dates

First Submitted

March 27, 2020

First Submitted That Met QC Criteria

March 30, 2020

First Posted (Actual)

March 31, 2020

Study Record Updates

Last Update Posted (Actual)

May 24, 2021

Last Update Submitted That Met QC Criteria

May 20, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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