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.
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.
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
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.
National Hospital for Tropical Diseases
Hanoi, Vietnam
Can Gio COVID Hospital
Ho Chi Minh City, Vietnam
Cho Ray Hospital
Ho Chi Minh City, Vietnam
Cu Chi COVID Hospital
Ho Chi Minh City, Vietnam
Hospital for Tropical Diseases
Ho Chi Minh City, Vietnam
Guy Thwaites, PhD. MD, Principal Investigator
University of Oxford, UK